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Committee 5

Initial Assessment of Urinary and Faecal Incontinence in Adult

Male and Female Patients

Chairman

D. STASKIN (USA)

Co-Chairman

C. KELLEHER (U.K)

Members

K. AVERY (U.K),

R. BOSCH (N.L),

N. COTTERILL (U.K),

K. COYNE (USA),

A. EMMANUEL (U.K),

M. YOSHIDA (JAPAN)

Consultant

Z. KOPP (USA)

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REFERENCES

5B - E. RECOMMENDATIONS FORRESEARCH

5B - D. PATIENT REPORTEDOUTCOME (PRO)

QUESTIONNAIRES TO ASSESSTHE IMPACT OF URINARY

INCONTINENCE, OAB AND LOWERURINARY TRACT SYMPTOMS

5B - C. INTERNATIONALCONSULTATION ON

INCONTINENCE MODULARQUESTIONNAIRE (ICIQ):

WHAT IS THE ICIQ?

5B - B. RECOMMENDED PROQUESTIONNAIRES

5B - A. THE MEASUREMENT OFPATIENT-REPORTED OUTCOMES

(PROS) OF INCONTINENCE,OTHER LOWER URINARY TRACT

SYMPTOMS, AND BOWELPROBLEMS

INTRODUCTION

REFERENCES

I. FAECAL INCONTINENCEASSESSMENT

5A - B. INITIAL ASSESSMENT OFFAECAL INCONTINENCE

V. THE MALE PATIENT

IV. THE FEMALE PATIENT

III. THE UTILITY OF POST-VOIDINGRESIDUAL [PVR] URINE VOLUMEDETERMINATION IN THE INITIALASSESSMENT OF INCONTINENT

PATIENTS

II. URINALYSIS IN THE EVALUATIONOF THE PATIENT WITH LUTS AND UI

I. LOWER URINARY TRACTSYMPTOMS

5A - A. INITIAL ASSESSMENT OFURINARY INCONTINENCE INADULT MALE AND FEMALE

PATIENTS

CONTENTS

Committee 5 B

Patient-Reported Outcome Assessment

CONTENTS

Committee 5 A

Initial Assessment of Urinary and FaecalIncontinence in Adult Male and Female Patients

333

Organization of this committee report

Urinary (UI) and faecal incontinence (FI) are a concernfor individuals of all ages and both sexes. This reportreviews the “initial assessment” of urinary and faecalincontinence – and in addition, reviews the availableoutcome measures for symptom assessment andquality of life for these disorders. Therefore, the reportis divided into 2 major sections: 5A-A initial assessmentof urinary incontinence (UI) in adult male and femalepatients, 5A-B initial assessment faecal incontinence(FI) and 5B outcome measures. The initial assess-ments for the conditions of incontinence in paediatric,neurogenic, and geriatric patients and for patientswith pelvic pain are presented in the specificCommittee reports pertaining to these sub-groupsand conditions.

For the purpose of this report, the ‘initial assessment’represents the components of the history, physicalexamination, laboratory tests, and basic office testingto:

1. Establish a presumptive or condition specificdiagnosis, and exclude underlying organ-specificrelated or unrelated conditions that would requireintervention.

2. Assess the level of bother and desire forintervention from information obtained from thepatient or caregiver.

3. Institute empiric or disease specific primary therapybased on the risk and benefit of the untreatedcondition, the nature of the intervention and thealternative therapies.

4. Prompt the recommendation of additional morecomplex testing or specialist referral.

Within the initial assessment of UI, various sub-populations / subgroups are recognized because ofthe differences within patient groups or theinterrelationship between the conditions. The sub-sections in this report should be utilized in conjunctionwith other population or condition specific CommitteeReports of the Consultation and the final recom-mendations of the Consultation which are presentedin simplified form along with treatment algorithms inthe Management Recommendations. These sub-groups include patients with lower urinary tractsymptoms (LUTS) without incontinence and with pelvicpain. The requirements of specific sub-populationsnegate the ability to recommend a ‘universal’ initialevaluation. Pelvic organ prolapse in the female andprostatic obstruction in the male require uniquelydifferent approaches to lower urinary tract dysfunction.Congenital and maturational issues in the paediatricsubgroup and the effects of ageing on the lower urinarytract and medical co-morbidities in the geriatric grouppresent unique challenges. Specific risks for combinedstorage and emptying abnormalities and upper urinarytract deterioration in the neurogenic bladder populationdemand a more involved initial evaluation.

This committee report is evidence based and utilizesthe ICUD - EBM grades. A search of the availableliterature in English obtained from Medline© andPubmed© up to June 2008 by the individual committeemembers utilized multiple search terms related toassessment (eg., ‘urinary incontinence’, ‘faecalincontinence’, ‘lower urinary tract symptoms’, ‘vaginalprolapse’, and terminology related to ‘outcomeassessments’ and ‘quality of life measures’).

5A- A. INITIAL ASSESSMENT OFURINARY INCONTINENCE INADULT MALE AND FEMALE

PATIENTS

INTRODUCTION

Committee 5 A

Initial Assessment of Urinary and Faecal Incontinence in Adult

Male and Female Patients D. STASKIN, C.KELLEHER,

R.BOSCH, K.COYNE, N. COTTERILL, A. EMMANUEL, M.YOSHIDA, Z. KOPP

334

Purpose of the initial assessment

The initial assessment must consider the degree ofbother, and the costs of further evaluation, balancedagainst the consequences of a failure to diagnose anunderlying condition, the risk and benefits of conser-vative management or pharmacological therapy andthe need for an accurate diagnosis before morecomplex intervention or empiric therapy. The burdenof these conditions and the availability of resourcesto different patients, physicians, and health caresystems require that primary intervention strategiesbe formulated, when available from evidence basedfindings and decisions emanating from the initialevaluation. As will be noted, especially in thiscommittee report, the amount and sophistication of theliterature that contributes to the levels of evidencethat are available for determining the grades ofrecommendation in the area of “initial assessment”may often rely on expert opinion of the panel.

Of note, LUTS cannot be used to make a definitivediagnosis of a specific lower urinary tract condition orlower urinary tract disease (LUTD), as these symptomsmay suggest and indicate pathologies such as urinaryinfection or more serious underlying conditions. Basiclaboratory tests, such as testing for urinary or faecalinfection or blood, and appropriate screening formalignancy should be considered before the decisionis made to choose therapy for incontinence.

Concomitant pathology may affect urinary or faecalproduction as co-morbid contributory issues, byaffecting fluid balance or renal function (dietary oralimentary function) and may need to be addressed.The physician should elicit neurological symptomsand signs that may indicate alterations in the controlof the lower urinary tract / bowel function or thecognitive, motivational, physical, and environmentalfactors that determine the ability to perform toiletingfunctions effectively.

Symptoms are either volunteered by, or elicited from,the individual or may be described by the individual’scaregiver. The International Continence Society (ICS)has classified lower urinary tract symptoms (LUTS)into storage, voiding, and post-micturition symptoms[1]. The National Institutes of Health (NIH) recommendsimilar (but not identical) standards of terminology inpelvic floor disorders[2]. Although an accurateurological history will not establish a definitive diagnosisit will ultimately guide investigation and treatment [1].

The following section summarises the definitions ofsymptoms described by the International ContinenceSociety [1].NIH definitions are given (in italics and inparentheses) where they differ from ICS terminology.

1. STORAGE SYMPTOMS

OVERACTIVE BLADDER (OAB) - Urgency with or withouturgency incontinence usually with frequency andnocturia in the absence of an underlying metabolic orpathological condition.

URINARY INCONTINENCE (UI) is the complaint of anyinvoluntary leakage of urine. In each specificcircumstance, urinary incontinence should be furtherdescribed by specifying relevant factors such as type,frequency, severity, precipitating factors, social impact,effect on hygiene and quality of life, the measuresused to contain the leakage (wearing of protection,number and type of pads and change of underwearor outer clothes) and whether or not the individualseeks or desires help because of urinary incontinence.Urinary leakage may need to be distinguished fromperspiration or vaginal discharge.

STRESS URINARY INCONTINENCE (SUI) is the complaintof involuntary leakage on effort or exertion, or onsneezing or coughing (NIH – the patient’s or caregiver’sstatement of involuntary loss of urine during physicalexertion).

URGENCY URINARY INCONTINENCE (UUI) is the complaintof involuntary leakage accompanied by or immediatelypreceded by urgency. Urge incontinence can presentin different symptomatic forms; for example, asfrequent small losses between micturition or as acatastrophic leak with complete bladder emptying.Information should be sought on triggering eventssuch as cold, running water and ‘latch key’incontinence.

MIXED URINARY INCONTINENCE (MUI) is the complaint ofinvoluntary leakage associated with urgency and alsowith exertion, effort, sneezing or coughing.

CONTINUOUS URINARY INCONTINENCE is the complaint ofcontinuous leakage.

OTHER TYPES OF URINARY INCONTINENCE may besituational, for example the report of incontinenceduring sexual intercourse. Coital incontinence mayoccur during arousal, on penetration, throughoutintercourse, or specifically at orgasm; althoughurodynamic stress incontinence is the most commonurodynamic finding in each of these situations, detrusoroveractivity is found more often when leakage isrestricted to orgasm [3].

URGENCY is the complaint of a sudden compellingdesire to pass urine which is difficult to defer (NIH –the statement that the patient feels a strong need topass urine for fear of leakage).

INCREASED DAYTIME FREQUENCY is the complaint ofvoiding too often by day (NIH - the statement that thepatient voids eight or more times in 24 hours).

Increased daytime frequency may arise in thepresence of a normal bladder capacity when there is

I. LOWER URINARY TRACTSYMPTOMS

335

excessive fluid intake, or when bladder capacity isrestricted secondary to detrusor overactivity, impairedbladder compliance, or increased bladder sensation.

NOCTURIA is the complaint that the individual has towake at night one or more times to void (NIH - thestatement that the patient wakes from sleep to passurine). The term ‘night time frequency’ differs from thatfor nocturia, as it includes voids that occur after theindividual has gone to bed, but before he/she hasgone to sleep, and voids which occur in the earlymorning which prevent the individual from gettingback to sleep as he/she wishes. These voids beforeand after sleep may need to be considered in researchstudies. If this definition were used then an adapteddefinition of daytime frequency is required. Nocturiamay arise for similar reasons to daytime frequency,but may also occur due to an increase in fluid outputdue to other physiological abnormalities resulting in‘nocturnal polyuria’. (see Bladder diaries below).

NOCTURNAL ENURESIS is the complaint of loss of urineoccurring during sleep. Enquiry should includeprevious childhood nocturnal enuresis as delayedbladder control in childhood is associated with detrusoroveractivity in adulthood.

BLADDER SENSATION may be categorised as:

NORMAL: the individual is aware of bladder filling andincreasing sensation towards capacity.

INCREASED: the individual feels an early and persistentdesire to void.

REDUCED: the individual is aware of bladder filling butdoes not feel a definite desire to void.

ABSENT: the individual reports no sensation of bladderfilling or desire to void.

NON-SPECIFIC: the individual reports no specific bladdersensation but may perceive bladder filling as abdominalfullness, vegetative symptoms, or spasticity. Thesesymptoms are most frequently seen in neurologicalpatients, particularly those with spinal cord trauma ormalformation.

2. VOIDING SYMPTOMS

Voiding symptoms may occur in situations of overactiveoutlet, or under active detrusor[1]. The former may besecondary to outlet obstruction from urogenitalprolapse, urethral stricture or following previous bladderneck surgery. Detrusor atonia or hypotonia is howevermuch more common in the female, and may ariseidiopathically, or secondarily to over distension afterparturition or surgery, in peripheral neuropathy due todiabetes mellitus, and in other neurological conditions.Women with prolapse may require to digitate vaginallyto initiate or complete voiding.

SLOW STREAM is the individual’s perception of reducedurine flow, usually compared to previous performanceor in comparison to others.

INTERMITTENT STREAM (INTERMITTENCY) is when theindividual describes urine flow which stops and starts,on one or more occasions, during micturition.

HESITANCY is when an individual describes difficulty ininitiating micturition resulting in a delay in the onsetof voiding after the individual is ready to pass urine.

STRAINING to void describes the muscular effort usedto initiate, maintain or improve the urinary stream.

TERMINAL DRIBBLE is the term used when an individualdescribes a prolonged final part of micturition, whenthe flow has slowed to a trickle.

POST-MICTURITION SYMPTOMS

Post micturition symptoms are experiencedimmediately after micturition.

FEELING OF INCOMPLETE EMPTYING is a self-explanatoryterm for a feeling experienced by the individual afterpassing urine.

POST MICTURITION DRIBBLE is the term used when anindividual describes the involuntary loss of urineimmediately after he or she has finished passing urine,usually after leaving the toilet in men, or after risingfrom the toilet in women.

3. MEASURING THE FREQUENCY ANDSEVERITY OF LOWER URINARY TRACTSYMPTOMS

The frequency-volume chart or micturition diary recordsa patient’s voiding pattern during normal daily activities.In some women it may be therapeutic as it providesthem with insight into their bladder behaviour [4]. TheICS has described three different forms of diary,namely the micturition time chart which records thetiming of voids in twenty four hours; the frequencyvolume chart (FVC) which also includes the volumesvoided , and the bladder diary which in additionincludes incontinence episodes, pad usage, fluid

intake, degree of urgency and degree of incontinence.1

However, increasing either the complexity of the diaryor duration of recording is associated with poorercompliance [5]. The optimum duration of recordingdepends on the clinical context and the purpose of themeasurement. A properly performed 1-day FVC, whichincludes the first morning void the following day, is areasonable tool to gain insight into voiding habitsduring normal daily routine.

However, a 3-day FVC or diary is recommended foraccurate assessment of lower urinary tract symptomsand for confirming a consistent clinical pattern in day-to-day practice. Although never completely diagnostic,several different diary patterns have been describedwhich may characterise normal and abnormalstates[6]. For atypical clinical scenarios, a 7-day FVCor diary should be used. Equally, a 7-day diary hasbeen recom-mended for clinical research, [7] however,of note, most pharmacological studies now employ a

336

three day diary as a standard for improved patientcompliance (see Committee Report Pharmacologyfor further recommendations.

The following measurements can be abstracted fromfrequency volume charts and bladder diaries:

DAYTIME FREQUENCY is the number of voids recordedduring waking hours and includes the last void beforesleep and the first void after waking and rising in themorning.

NOCTURIA is the number of voids recorded during anight’s sleep; each void is preceded and followed bysleep.

NIGHT-TIME FREQUENCY is the number of voids recordedfrom the time the individual goes to bed with theintention of going to sleep, to the time the individualwakes with the intention of rising.

24-HOUR FREQUENCY is the total number of daytimevoids and episodes of nocturia during a specified 24hours period.

24-HOUR PRODUCTION is measured by collecting allurine for 24 hours; this is usually commenced after thefirst void produced after rising in the morning and iscompleted by including the first void on rising thefollowing morning.

POLYURIA is defined as the measured production ofmore than 2.8 litres of urine in 24 hours in adults. Itmay be useful to look at output over shorter timeframes.

NOCTURNAL URINE VOLUME is defined as the total volumeof urine passed between the time the individual goesto bed with the intention of sleeping and the time ofwaking with the intention of rising. Therefore, itexcludes the last void before going to bed but includesthe first void after rising in the morning.

NOCTURNAL POLYURIA is present when an increasedproportion of the 24-hour output occurs at night(normally during the 8 hours whilst the patient is inbed). The night time urine output excludes the lastvoid before sleep but includes the first void of themorning. The normal range of nocturnal urineproduction differs with age and the normal rangesremain to be defined. Therefore, nocturnal polyuriais present when greater than 20% (young adults) to33% (over 65 years) is produced at night. Hence theprecise definition is dependent on age.

AVERAGE VOLUME VOIDED is the mean volume of urinepassed in each void. This is calculated by dividing totalvoided volume by number of voids.

NORMALISED MICTURITION FREQUENCY is a moremeaningful way of expressing voided volume. Thisis defined as the number of micturitions required topass 1 litre of urine, and is calculated by dividing 1000

ml by average volume voided. This is a more specificmeasure of bladder function than micturition frequency,since it takes into account behavioural, dietary andpharmacological factors that affect urine volume.

MAXIMUM VOIDED VOLUME is the largest volume of urinevoided during a single micturition and is determinedeither from the frequency/volume chart or bladderdiary.

INCONTINENCE EPISODE FREQUENCY is the number ofepisodes of accidental urine leakage that occur overa specified period (e.g. 24 hours).

URGENCY is the complaint of a sudden compellingdesire to pass urine, which is difficult to defer, andwhich leads to a fear of incontinence. The impact ofthis symptom may be derived from a bladder diary byrecording episodes of urgency, episodes of urgencyleading to incontinence and severity of urgency (e.g.using a daily visual analogue scale).

PAD USAGE is the number of pads used over a specifiedperiod (e.g. 24 hours).

Recommendations

1. Lower Urinary Tract Symptoms (LUTS) cannotbe used to make a definitive diagnosis; theymay also indicate pathologies other than LowerUrinary Tract Disease (LUTD). Specific to thisreport, LUTS may include Overactive Bladder(OAB) a syndrome which may be associatedwith urgency incontinence (OAB-wet) or withoutincontinence (OAB-dry). Likewise, bowelsymptoms should prompt consideration and asappropriate, an evaluation for other similarsymptom based pathology. (Level 5 - Grade D)

2. Urinary and faecal incontinence should bedescribed by specifying relevant factors such astype, frequency, severity, precipitating factors,social impact, effect on hygiene and quality oflife, the measures used to contain the leakageand whether or not the individual seeks ordesires help. (Level 5 - Grade D)

3. Urinary incontinence should be categorized bysymptoms into urgency incontinence, stressincontinence or mixed incontinence andconservative (non-invasive) therapies may thenbe started based on this classification to treatthe most troublesome component, or eithercomponent of the incontinence. (Level 5 - GradeD) More sophisticated testing (eg. urodynamicstudies) is not required prior to the institution ofconservative therapy (see indications forurodynamics in the Committee Report onUrodynamic Studies). (Level 3 - Grade C)

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Future research

1. Standardisation of the ‘definition of symptoms’ andthe ‘measurements of symptom frequency, severityand bother’ are essential for patient care andresearch. Continued research into the appropriatescales and metrics should be accompanied by asignificant attempt to establish best practiceguidelines for their use and a consensus on theadoption of universal standards.

2. Recognition and resolution of the differences incommon language usage and scientific utilisationof terms should continue (e.g. common use of‘urge to void’ and the ‘desire to void’ versus the ICSterminology of “urgency”). In addition, continuedresearch into the development of accuratemeasures to objectify subjective symptoms suchas “urgency”. This would include resolution of thedifferences in the ICS and NIH definitions (inaddition to other regulatory agencies) is essentialfor communicating data with respect to patientcare, research, and treatment outcomes.

3. Further development and standardisation ofsymptom assessment tools (questionnaires) toimprove the diagnostic accuracy of lower urinarytract symptoms. (Refer to section 2 of thiscommittee’s report)

4. Further validation of the accuracy of specificcomponents of the history and physical findings toestablish an accurate diagnosis and initiate non-invasive conservative or pharmacological therapy.In addition, to further identify components thatwould indicate the need for more invasive testing,complex therapeutic interventions, and indicationsfor referral.

“The urinalysis is a fundamental test that should beperformed in all urological patients. Although in manyinstances a simple dipstick urinalysis provides thenecessary information, a complete urinalysis includesboth chemical and microscopic analysis” [8].

In relation to urinary incontinence, dipstick urinalysisis not a diagnostic test, but a screening test, importantin order to detect haematuria, glucosuria, pyuria andbacteriuria. Haematuria can indicate importantpathology such as urothelial carcinoma in situ, leadingto lower urinary tract storage symptoms includingincontinence [9]. Glucosuria is relevant, as a potentialindicator of diabetes mellitus. This can causesymptoms via several mechanisms including polyuriasecondary to osmotic diuresis, peripheral autonomicneuropathy affecting bladder innervation leading toimpaired bladder emptying and chronic urinaryretention and finally due to increased risk of urinarytract infection (UTI), directly related to the glucosuriaand as a sequel to impaired bladder emptying.

Pyuria and bacteriuria, detected from urinary dipstickleukocyte esterase and nitrite tests respectively, areimportant signs of urinary tract infection. The specificityand sensitivity of these latter tests for UTI is increasedwhen used together compared to either individual test[10,11]. Even in the absence of controlled studies,there is general expert consensus that the benefits ofurinalysis clearly outweigh the costs involved, althoughthe use of urinalysis should always be associatedwith prognostic significance [12]. A positive dipstickurinalysis will prompt formal urine microscopy andculture to detect UTI prior to antibiotic treatment and/orthe use of additional tests such as endoscopy andurinary tract imaging. In the evaluation of urinaryincontinence and lower urinary tract symptoms, thevalue of urinalysis can be illustrated by the findingthat 60% of women with stable bladder will developdetrusor overactivity at the time of UTI.

The importance of urinalysis in the basic assessmentof patients with urinary incontinence and lower urinarytract symptoms is not dependent on gender, age oraetiology. Indeed, it has been recommended in theevaluation of geriatric patients including nursing homeresidents who are incontinent, [13,14] in peri- andpostmenopausal women, [15] and in older women

II. URINALYSIS IN THE EVALUATIONOF THE PATIENT WITH LUTS AND UI

4. A bladder diary is recommended in order todocument and communicate the frequency ofvoids and incontinence episodes experiencedby the patient - as well as additional metrics.Additional information as appropriate mayinclude volume of intake, voided volume, and /or symptoms such as urgency or discomfort.Additional metrics may be added for researchpurposes such as degree of urgency or timefrom urgency to toileting. A bladder diary isrecommended for a minimum of 3 days foraccuracy (Level 3 - Grade C) as the idealduration is not clear (Level 4). The committeeacknowledges the difficulty with patientcompliance and acknowledges some value ofshorter periods for patient compliance. (Level5 - Grade D).

5. Referral to a specialist is recommended forhematuria (visible or microscopic), urinary tractinfection (persistent or recurrent), prolapse(symptomatic or below the introitus) , obstructionor retention (symptoms or findings of palpablebladder, hydronephrosis or obstructive renalinsufficiency), suspected neurological disease,mass (urethral, bladder or pelvic - benign ormalignant), fistula (urinary or bowel), faecalincontinence, a history of prior pelvic surgery orradiation (incontinence, oncologic) (Level 5 -Grade D).

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reporting urinary incontinence [16]. In the latter context,it has been suggested that significant urine samplescan even be obtained from disposable diapers inelderly incontinent women [17].

A Norwegian survey of general practitioners’management of female urinary incontinence suggestedthat urinalysis is the most frequently performed test(73%) and is far more frequent than gynaecologicalexamination (54%) [18]. Another survey proposedthat urinalysis is one of the three-part assessment ofurinary incontinence together with patient history andphysical examination [19].

The clinical relevance of asymptomatic bacteriuria(without pyuria) and pyuria (without bacteriuria) in theelderly is controversial, as eradication of bacteruriaappeared to have no effect on resolution ofincontinence, and many suggest thtat it does notdeserve any treatment. [20,21].

Recommendation

Future research

1. Determine the role of urinalysis as a screeningtest in various incontinent populations, specificallythe elderly patient with acute or establishedincontinence in combination with asymptomaticbacteruria. Specifically, to determine the relevanceof asymptomatic bacteriuria without pyuria, andpyuria without bacteriuria, in elderly patients. (seeGeriatric Committee Report).

2. Determine the prognostic significance of urinalysisresults and the impact of therapy the outcome oftreatment of urinary incontinence.

The PVR is the volume of urine remaining in thebladder following a representative void. PVRmeasurement can be accomplished within a fewminutes of voiding either by catheterisation or bycalculation of bladder volume using a portableultrasound scanner. Several studies have comparedvolumes measured with portable ultrasound scannersversus catheterisation and found portable scannersto be 85-94% accurate [22,23]. A study has imagedthe bladder volume after catheterisation and foundthat the volume of urine remaining in the bladder aftercatheterisation accounted for most of the differencebetween the two measurements [22]. Bimanualpalpation cannot reliably estimate the post-voidresidual urine volume [24].

Since PVR may vary, one measurement of PVR maynot be sufficient [25]. PVR should probably bemeasured several times to increase its reliability.Griffiths et al found a significant variability in PVRmeasurement depending on the time of the day, withthe greatest volume occurring in the morning [26]. Anon-representative PVR is particularly common if thepatient’s bladder is not full enough to yield an urge tovoid.

An increased PVR alone is not necessarily problem,but if combined with high pressures it can lead toupper tract problems. If related to UTI’s, PVR mayneed to be treated since UTI’s may not be eradicatedin the presence of an infected residual. A significantPVR also decreases the functional bladder capacityand contributes to urgency/frequency, urgeincontinence and nocturia. However, a Scandinavianstudy in nursing home residents found that an elevatedPVR was not associated with bacteruria and incon-tinence [27].

Review of the literature does not show an evidence-based specific maximum PVR that is considerednormal, nor is there a minimal PVR that is consideredabnormal. The amount of residual urine that precludestreatment by various therapies has also not beendetermined. The AHCPR guidelines state that, ingeneral, a PVR less than 50 ml is considered adequatebladder emptying and over 200 ml is consideredinadequate emptying (expert opinion of the panelmembers) [28].

III. THE UTILITY OF POST-VOIDINGRESIDUAL [PVR] URINE VOLUMEDETERMINATION IN THE INITIALASSESSMENT OF INCONTINENT

PATIENTS

1. It is considered standard to perform a urinalysiseither by using a dipstick test or examining thespun sediment. (Level 5 - Grade D)

2. If a dipstick test is used, it is recommended thata “multiproperty” strip that includes fields forhaematuria, glucose, leukocyte esterase andnitrite tests be chosen. (Level 5 - Grade D)Dipstick is not as accurate as urine culture,being specific for infection but not sensitive.(Level 2 - Grade C)

3. Additional tests available on urine dipstick strips,such a protein, bilirubin, ketones and pH, maybe helpful in the broader medical managementof patients. However, they are not essential inthe context of evaluation of the patient withurinary incontinence or lower urinary tractsymptoms. (Level 5 - Grade D)

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“Normal values” of PVR have been determined inseveral groups of non-incontinent and incontinentwomen. Gehrich et al studied 96 women (mean age60 ± 11 yrs) that were seen in a well-women clinic.These women had no history of incontinence,retention, symptomatic prolapse or neurologicdisorders. Most (97%) had a minor (asymptomatic)degree of prolapse, 80% was post-menopausal and30% had had a hysterectomy. The median PVR was19 ml (range 0-145 ml; mean 24 ± 29 ml); only 5% hadPVR > 100 ml. Only, age > 65 yrs was associated withhigher PVR [29]. Tseng et al studied 107 women withurodynamic stress incontinence. They found a meanPVR of 62.5 ml by bladder scan and 38.5 ml bycatheterization. Only 15.9% had a PVR greater than100 ml. The PVR determined by bladder scan offereda sensitivity of 64.7% and a specificity of 94.3% indetecting PVR greater than 100 ml [30]. Haylen et alstudying women with lower urinary tract dysfunctionfound that 81% had a PVR of less than 30 ml Postvoidresidual volumes higher than this level are significantlyassociated with increasing age, higher grades ofprolapse, and an increased prevalence of recurrentUTIs. [31]. Fitzgerald et al studied women with urgency,frequency and urge incontinence: 10% had an elevatedPVR of > 100ml. In these women with OAB, thefollowing independent risk factors of increased PVRwere found: vaginal prolapse, symptoms of voidingdifficulty and abscence of stress-incontinence [32].Lukacz et al found that only 11% of women with pelvicfloor disorders had an elevated PVR [33]. Wu andBaguley studied 319 consecutive patients (196 women,123 men) in a subacute general, but predominantlygeriatric, rehabilitation unit. 22 had been admittedwith catheter and were excluded. Of the 297“asymptomatic” patients, 21.5% had PVR volumesof 150 mL or more. Patients with elevated PVR (>150 ml) were significantly more likely to have a urinarytract infection at admission and have urinaryincontinence on discharge [34]. Milleman et alretrospectively reviewed 201 women (mean age 55;range 20-90) who presented with complaints of urinaryfrequency, urgency and /or urge incontinence. 19% hadan elevated PVR of more than 100 ml (mean 211 ml;range 100-997 ml). On multivariate analysis thefollowing independent predictors of raised PVR wereidentified: age > 55 yrs [OR 3.71], prior incontinencesurgery [OR 4.32], a history of multiple sclerosis [OR15.32] and pelvic organ prolapse grade 2 or greater[OR 3.61] [35].

In summary, an elevated PVR > 100 ml was found in5% of women visiting a well-women clinic, in 10- 19%of women with OAB, in 11% of women with pelvicfloor disorders and in 15.9% of women withurodynamic SUI.

Does a significant PVR have an impact on the outcomeof treatment in patients with incontinence? Nager etal studied the predictive value of urodynamic measures

on stress continence outcomes after surgery for stressurinary incontinence. They found that urodynamicmeasures do not predict outcomes. However, sincewomen with PVR > 150 ml were excluded in thisstudy, one can only conclude that PVR volumes <150 ml did not have an adverse impact on stresscontinence outcome [36].

POST VIOIDING RESIDUAL URINE IN THEMALE PATIENT

PVR measurement is especially recommended inmen with suggestive of bladder outlet obstruction(BOO). PVR can be measured within a few minutesof voiding by catheterization to confirm that the bladderis empty [37] or by ultrasonography [38]. The AHCPRguidelines state that, in general, a PVR less than50ml is considered adequate bladder emptying andover 200ml is considered inadequate emptying. Morerecently, a dedicated ultrasound system has beendeveloped for automatic measurement of PVR, therebyimproving the accuracy over catheterization [39] whichhas been largely abandoned in clinical practice.International Consultation on BPH defined a rangeof 50 to 100 ml as the lower threshold to defineabnormal PVR [40]. Both the AUA and the EAUguidelines suggest a threshold of 300 ml to identifypatients at risk of unfavorable outcome following LUTS/ BPO treatment [41,42].

There is no consensus about the relation betweenPVR and UTI in the male patient. Although the negativerole of large residuals has been reported, the evidenceis controversial. Large residual urine volume has beenconsidered a bad prognostic factor for diseaseprogression. However, in the standard patients, renalfailure, acute retention and UTIs are uncommon in menwith large, chronic residuals [43]. No factors areavailable to identify patients, with significant residualurine, who are at risk for progression [44].

Therefore, on the basis of these trials, untreated LUTSmay place the male patient at risk for potential clinicaldeterioration. Thus, periodical measurements of PVRare recommended in such patients.

Recommendations

1. Female patients who present with storage specificsymptoms, with normal sensation and nocomplaints of decreased bladder emptying, andno anatomical, neurological, organ-specific, orco-morbid risk factors for retention may beassessed for bladder emptying by history andphysical examination alone, depending on thepotential morbidity of the failure to diagnose andthe nature of the intended therapy. (Grade B).

2. A palpable bladder on physical exam is anindication for referral to a specialist (Grade D).

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Summary of recommendations

Varying degrees of decreased bladder emptying orurinary retention may be a cause of LUTS that areassociated with symptoms of decreased urinarystorage.

The decision to perform a PVR in disease specificsub-groups of patients (eg., male patients with bladderoutlet obstruction, in neurogenic patients whodemonstrate combined disorders of storage andemptying, and preoperatively in female patients beingconsidered for incontinence surgery) should be basedon an association of the condition with poor bladderemptying (Grade D), whereas in individual patients thisdecision may be based on symptoms or physicalfindings. (Grade C)

Future Research

1. Development of more specific indications for PVRtesting for diagnosis and prior to instituting therapybased on history, physical examination, and diseasespecific findings.

2. Further development of low cost, minimally invasive,and accurate means of measurement of PVR thatdo not require catheterisation.

3 Continued research in subsets of patients isrequired to determine the need for PVR assessmentand the correlation between elevated PVR andtreatment outcome, generally, to determine theeffect of varying levels of PVR on the outcomes ofobservational, conservative, pharmacological andsurgical interventions, and more specifically, thefemale patient prior to surgeries that increase outletresistance, the male patient with bladder outletobstruction where medications that can potentiallydecrease bladder contractility are considered, andthe patient with elevated residual urine whereintermittent catheterization is not practical andwhere recurrent urinary tract infections anddecreased functional bladder capacity are potentialcomplicating factors.

1. GENERAL MEDICAL HISTORY

The general history should include questions relevantto precipitating and aggravating factors of urinaryloss, time of onset and duration of symptoms, anddegree of bother. Acute symptoms may be furtherdefined by documenting patterns of fluid intake andoutput, acute infection, recent surgery or trauma.Chronic symptoms may be further defined by elicitinga history of congenital abnormalities, neurologicaldisease, relevant surgery or general health. Informationmust be obtained on medications with known orpossible effects on the lower urinary tract. The generalhistory should also include assessment of menstrual,obstetric, sexual and bowel function. The reader isreferred to the report of the Committee on Epide-miology for risk specific risk factors to be consideredduring the medical history and to the second sectionof this report for recommendations for disease specificquestionnaires.

2. URINARY SYMPTOMS

Women with urinary incontinence may have had thecondition for many years before presenting; they areoften embarrassed in disclosing their condition and arelikely to have undertaken significant adaptations to theirlifestyle to ameliorate their symptoms [45]. Inestablishing the history the opportunity should betaken not only to describe symptoms, but also theirprogression, impact on lifestyle and possible riskfactors. Multiple symptoms are commonly reported,[46] and during the history it is important to define themost troublesome symptoms and the patient’sexpectations from treatment.

Section 2 of this Committee Report presents acomplete review and evaluation of questionnairesthat are applicable for clinical and research use inevaluating patient symptoms. Structured conditionspecific questionnaires may be used, [47]and maybe either clinician or self-administered. Questionnairesmay facilitate disclosure of embarrassing symptoms,ensure that symptoms are not omitted, and standardiseinformation thereby aiding audit and research.

3. CORRELATION OF SYMPTOMS AND SIGNS WITH SOPHISTICATED TESTING

Harvey & Versi evaluated the symptom and sign ofstress incontinence in predicting the presence ofurodynamic stress incontinence, using the results ofa MEDLINE search for ‘urinary incontinence’,‘urodynamic’ or ‘urodynamics’ [48]. Of 42 articlesevaluated,12 yielded analysable data. The isolatedsymptom of stress incontinence had a positivepredictive value (PPV) of 56% for the diagnosis ofpure urodynamic stress incontinence (USI) and 79%for USI with other abnormalities. The PPV for stress

IV. THE FEMALE PATIENT3. Residual urine determination by bladder scan ispreferable to catheterisation due to the increasedmorbidity associated with instrumentation.(Grade D).

4. Due to the increased possibility of bladder outletobstruction due to prostatic obstruction isincreased in the male patient, the threshold forinvestigating residual urine in the male issignificantly lower (Grade D).

5. A PVR should be performed in patients wheredecreased bladder emptying is suspected,especially if treatments that decrease bladdercontractility or increase outlet resistance arebeing considered. (Grade D)

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incontinence with other symptoms was 77% for USIwith or without other abnormalities. A positive coughtest had a PPV of 55% for the diagnosis of pure USIand 91% for USI with other abnormalities. Theyconcluded that in isolation, either symptom or signwere poor predictors of USI, although in combinationprediction may be more promising [48].

Horbach reviewed the literature regarding the reliabilityof stress symptoms in predicting USI; PPV valuesranged from 64% to 90% [49]. Summitt et al reportedthat 53% to 71% of women with detrusor overactivity(DO) gave similar histories to those with pure USI[50].The PPV of a history of pure urge incontinencemay be as low as 37%, [51] and overactive bladdersymptoms (OAB) only 54%, [52] in the diagnosis ofDO. It is however of interest to note that in a secondaryanalysis of data from a drug study in patients withpredominant stress incontinence, the main determinantof concurrent urge symptoms was not thepathophysiological condition present (i.e. the presenceof concurrent detrusor overactivity) but the severity ofincontinence [53].

Martin et al, have reported a systematic review ofmethods of assessing urinary incontinence.(54) Froman electronic search of MEDLINE, EMBASE andCINAHL between 1966 and 2002 they identified 6009individual papers; only 197 were relevant, and of these121 reached the standards required of their report.Only a limited number could be combined andsynthesised, although they were able to concludethat a large proportion of women with urodynamicstress incontinence can be correctly diagnosed inprimary care from clinical history alone (sensitivity0.92; specificity 0.56). The value of validated scalesand pad tests could not be determined from theavailable data. The urinary diary appears to be themost cost effective of tests that might be usedalongside clinical history within the primary care setting(sensitivity 0.88; specificity 0.82) [54].

Holroyd-Leduc performed a systematic reviewconcerning the most accurate way to determine thetype of urinary incontinence during an officeassessment was performed incorporating a reviewof the literature form 1966-July 2007. The authorsfound that “In women, simple questions modestlyhelped diagnose stress urinary incontinence but aremore helpful in diagnosing urge urinary incontinence.They concluded that a positive bladder stress testmay help diagnose stress urinary incontinence,however, a negative test is not as useful. Also, asystematic assessment combining the history, physicalexamination, and results of bedside tests to establisha clinical diagnosis appears to be of modest value indiagnosing stress urinary incontinence. In addition, asystematic assessment is less helpful in diagnosingurge urinary incontinence They concluded that “themost helpful component for diagnosing urge urinaryincontinence is a history of urine loss associated with

urgency. A bladder stress test may be helpful fordiagnosing stress urinary incontinence [55].

The reader is referred to the report of the Committeeon Sophisticated Testing - Urodyamics for specificindications for complex testing

4. OTHER SYMPTOMS OF PELVIC FLOOR DYSFUNCTION IN THE FEMALE PATIEINT

a) Prolapse symptoms

The feeling of a lump (“something coming down”),low backache, heaviness, dragging sensation, or theneed to digitally replace the prolapse in order todefaecate or micturate, are amongst the symptomswomen may describe who have a prolapse. Prolapsesymptoms may be associated with urinary storage oremptying symptoms. Outlet symptoms as diverse asgenuine or occult stress incontinence or obstruction,and bladder overactivity or underactivity may have acommon aetiology, exist as a cause or effect, or co-exist with lower urinary tract dysfunction.

b) Bowel symptoms

In addition to urinary complaints, women may havesymptoms relating to bowel function, sexual function,and pelvic organ prolapse (POP). Jackson et al.evaluated 247 women with either UI or POP. Thirtyone percent of women with UI and 7% with POP hadconcurrent anal incontinence (AI) [56]. In a reportfrom Sweden, 62% of 21 consecutive womenundergoing a Burch colposuspension for urodynamicstress urinary incontinence had concurrent faecalincontinence [57]. In a Norwegian study of womenpresenting with a complaint of urinary incontinence(UI), 38% of the women were found to have significantprolapse and 19% reported faecal incontinence [58].All these aspects of the pelvic floor and pelvic floorfunction must be included to plan a comprehensivetreatment strategy.

c) Symptoms associated with sexualdysfunction

Dyspareunia, vaginal dryness and coital incontinenceare amongst the symptoms women may describeduring or after intercourse. These various symptomsare reported by one third to two thirds of women withstress incontinence, and 68% report their sex life tobe spoilt by their urinary symptoms [59]. Symptomsof sexual dysfunction should be described as fully aspossible; it is helpful to define urine leakage asoccurring during arousal, on penetration, duringintercourse, or at orgasm (vide supra) [3].

5. PHYSICAL EXAMINATION

a) General examination

There are few data linking bladder, bowel, or sexualfunction to variations in examination findings of womenseeking routine gynaecological care. Similarly data on

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women with complaints of urinary incontinence donot include detailed, specific information about theirpelvic examinations.

Physical examination is essential in the assessmentof all women with lower urinary tract dysfunction.Height and weight should be recorded so that bodymass index can be calculated (Kg/M2); this hasrecently been shown to be a significant risk factor forincontinence [59].

Neurological examination should be performed, withattention to the sacral neuronal pathways. Assessmentof gait, abduction and dorsiflexion of the toes (S3)and sensory innervation to the labia minora (L1-L2),sole and lateral aspect of the foot (S1), posterioraspects of the thigh (S2), and perineum (S3) andcutaneous sacral reflexes (bulbo-cavernosus andanal reflexes) may be assessed. A rectal examinationwill provide a subjective assessment of resting andvoluntary anal tone (S2-S4). For patients with possibleneurogenic lower urinary tract dysfunction, a moreextensive neurological examination is needed (videinfra).

The agitated patient with urgency and frequency mighthave a behavioural cause and those who are clinicallydepressed have a less successful response to surgicaltreatment for stress urinary incontinence. A mini-mental state assessment will assess cognitive function,and is particularly helpful in the elderly (vide infra).Restriction in mobility may lead to functionalincontinence and a lack of hand dexterity may precludeself-catheterisation and the use of prostheticcontinence devices.

b) Abdominal examination

Scars from previous surgery should be noted.Increased abdominal striae may be found inassociation with other markers of abnormal collagenmetabolism, and are more likely in patients withprolapse and stress incontinence [60].

An attempt should be made to palpate the kidneys,particularly where a voiding dysfunction or neurogenicbladder dysfunction are suspected. A distendedbladder may be identified by abdominal palpation orby suprapubic percussion. In one study designed tolook at the clinical utility of basic assessment in elderlywomen, palpable enlargement indicated a post-voidresidual volume of at least 300ml [61].

c) Perineal/genital inspection

Inspection of the vulva and perineum allows adescription of the skin and, for example, the presenceof any abnormal anatomical features, of atrophy orexcoriation, and erythema due to incontinence and thewearing of pads.

The patient should be asked to cough and strain todemonstrate stress urinary incontinence and to

observe urethral length, position, and mobility, andreflex contraction of the external anal sphincter.Howard and associates tested vesical neck descentduring cough and Valsalva manoeuvre [62]. Theyfound incontinent women have similar vesical neckmobility with both manoeuvres, whereas continentwomen have less vesical neck descent with a coughthan with Valsalva.

The clinical sign of urinary incontinence is definedas urine leakage seen during examination; this maybe urethral or extra-urethral.

Stress urinary incontinence is the observation ofinvoluntary leakage from the urethra, synchronouswith exertion/effort, or sneezing or coughing. If stressurinary incontinence is suspected, provocative stresstesting (direct visualization) can be performed byhaving the individual relax and then cough vigorouslywhile the examiner observes for urine loss from theurethra. Optimally these tests should be done whenthe patient’s bladder is full, but they should not beperformed when the patient has a precipitant urge tovoid. The test is usually performed initially in thelithotomy position, although if no leakage is observed,it should be repeated in the standing position, sincethe yield is increased when the test is repeated in theupright position. Coughing may induce a detrusorcontraction, hence the sign of stress incontinencemay only be a reliable indication of urodynamic stressincontinence when leakage occurs synchronouslywith the first cough and stops at the end of that cough.It has however been shown that following an increasein intra-abdominal pressure, and the immediate fall inurethral closure pressure, there follows a ‘refractoryperiod’ of several seconds during which the urethramaintains a lower pressure than at rest [63]. Theextent of pressure loss, and the time to recovery areboth less in stress continent then stress incontinentwomen [64]. If further increases in intra-abdominalpressure occur during this time, stress leakage ismore likely to be demonstrated after a series of coughsthan following a single cough.

Bonney’s original stress test was performed todemonstrate urinary leakage during coughing [65].Subsequent modifications of the test require supportof the urethra-vesical junction during coughing inwomen who leak during a stress test. Thesemodifications are not reliable in selecting a surgicalprocedure or in predicting cure.

Extra-urethral incontinence is defined as theobservation of urine leakage through channels otherthan the urethra. This may result from congenitalabnormality such as ectopic ureteric opening, or fromurogenital fistula.

d) Urethro-vesical junction (bladder neck)mobility

Urethro-vesical junction (bladder neck) mobility should

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be assessed in all women with urinary incontinence.It is generally felt that women with urodynamicincontinence fall into several categories based onassessment of urethral support and urethral function.The choice of therapy may be affected by theassessment of bladder neck mobility [66]. One methodof assessing bladder neck mobility is by visualinspection. When the patient is in lithotomy position,the urethral meatus is horizontal to the floor in awoman with good bladder neck support. When sheincreases intra-abdominal pressure you can observefor posterior rotation of the anterior vagina anddeflection of the meatus toward the ceiling, both signsof some loss of support. You may ask her to contractthe pelvic muscles to determine if urethral supportimproves with muscle contraction, a sign pelvic floortraining may be therapeutic.

The cotton swab or Q-tip test is a simple out-patientprocedure to quantify bladder neck mobility [66]. Asterile, lubricated cotton or Dacron swab (Q-tip) isinserted into the urethra until it lies just within theurethra-vesical junction. Using a goniometer, the anglecircumscribed by the distal end of the swab ismeasured relative to the horizontal while the womanis performing a maximum Valsalva effort. Urethro-vesical junction hypermobility is defined by a maximumstrain axis exceeding +30 degrees from the horizontal.

There are no published reports about the reproducibilityof the cotton swab test for measuring bladder neckhypermobility, despite its widespread clinical applicationin the evaluation and management of women withurinary incontinence. The validity of this test fordiagnosing stress urinary incontinence was notsystematically evaluated until 15 years after itsintroduction. At that time, investigators found that asizable minority of women with the urodynamicdiagnosis of stress incontinence did not have a positivecotton swab test result [66] (considered a strainingangle >30°) and that many women with a positivecotton swab test result did not have stress urinaryincontinence on urodynamic testing. The test was notable to distinguish women with stress incontinencefrom continent control subjects [67,68], or womenwith stress incontinence from those with other urologicdisorders [69].The cotton swab test is now usedprimarily to assess results of incontinence surgery orto determine whether the degree of urethralhypermobility may influence treatment outcomes.Although the test is simple to perform, the insertionof the small cotton swab may be uncomfortable forsome women. Investigators have explored othermethods to assess hypermobility, including the POP-Q anatomic evaluation system and ultrasonography.In one study, the correlation coefficient between thecotton swab straining angle and point Aa (the urethro-vesical junction) on the POP-Q system was 0.47 [70].However, the cotton swab test was positive in 95% ofpatients with stage II prolapse at point Aa and in 100%

of patients with stages III and IV prolapse at point Aa,which suggests that the test may be unnecessary inpatients with stage II or greater prolapse at point Aa.A study evaluating the use of a urinary catheter toassess urethral hypermobility used the Q-tip test forcomparison in women with urinary incontinence andpelvic organ prolapse. Results of the study showedreduced angles of excursion from resting to Valsalvamanoeuvre using a catheter [71].

Ultrasonography can be used to measure the anglebetween the urethra and an axis corresponding tothe pubic symphysis, the urethra, the bladder base,and the position of the internal urethral meatus. Othertests to document bladder neck mobility are used,including bead-chain cystourethrography, andvideocystourethrography. The report of the Committeeon Imaging of the urinary tract addresses the placeof these techniques.

A comparison study was conducted to assess theinterobserver reliability of the Q-tip test, the Sensor-Qtrade mark test and ultrasonographic measurementof urethral mobility in women. 90 women took part inthe study; and underwent one method of theassessment by two different clinicians. The correlationcoefficient of the Q-tip test, the Sensor-Qtrade marktest and the ultrasonographic measurement was 0.83,0.92 and 0.43, respectively. The Sensor-Qtrade markand Q-tip test showed a higher inter-observer reliabilityfor the evaluation of urethral mobility compared toultrasound assessment [71,72].

The Q-tip test has been used in a number of studiesevaluating changes in urethrovescial junctionhypermobility and efficacy of surgical treatment ofstress incontinence including mid-urethral tapes,vaginal wall sling procedures and Burch colposu-spension [73-80]. A study investigating factorsassociated with severity of stress incontinence inwomen found that reduced urethral mobility using theQ-tip test was associated with greater severity ofurinary incontinence [81].

Correlation of Q-tip test and urethroscopic imaging ofthe f bladder neck was assessed in stress incontinentwomen. After the Q-tip test, patients underwent anurethroscopy; at bladder capacity the patient wasasked to strain and opening or closing of the bladderneck was noted. An abnormal Q-tip test duringValsalva (> 30°) was observed in 80% of patients. Theauthors suggest that a Q-tip test could diagnosebladder neck opening with a sensitivity of 91% anda specificity of 35% [82]. The correlation between thestraining Q-tip angle and anterior vaginal wall prolapseassessed using the POP-Q system has beeninvestigated in a number of studies. Noblett et alassessed the correlation between urethral mobilityand anterior wall prolapse, in order to determinewhether the Q-tip test was necessary in patients withstage 0/1 prolapse graded using the POP-Q system.

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Results of this study suggested that the POP-Q systemwas highly predictive of urethral hypermobility; thepositive and negative predictive values were 82%and 94% respectively [83].

A retrospective analysis conducted by Larrieux et alalso concluded that descent at point Aa is a strongpredictor of urethrovesical junction mobility, howeverurethral length did not affect the correlation betweenQ-tip angle and point Aa [84]. Zyczynski et alinvestigated the correlation between POP-Q gradedanterior vaginal wall prolapse and Q-tip test findingsin urinary incontinent women. The study showed thaton clinical examination, one third of the studyparticipants with urethral hypermobility by Q-tip testhad a well supported urethrovescial junction. Theresults of this study suggested that clinicians whodetermine urethral mobility by watching descent ofthe distal anterior vagina during Valsalva manoeuvremay underestimate the true incidence of urethralhypermobility [85].Mattison et al and Rosencrantz etal conducted retrospective reviews of a clinicaldatabase in order to determine the correlation betweenPOP-Q evaluation of anterior vaginal wall prolapse andthe straining Q-tip angle [86]. Mattison et al found thecorrelation between q-tip straining angle and pointAa was 0.54 (P<0.001). Rosencratz found correlationvalues between 0.26 and 0.78. Both studies concludedthat urethral hypermobility could not be predicted fromPOP-Q measurement alone [87].The Q-tip has notbeen shown to be predictive of Valsalva leak pointpressures in women with urethral hypermobility andstress urinary incontinence [88].

e) Vaginal examination

Presently there are few scientific data documentingthe parameters of a normal pelvic examination inwomen of various ages and with various obstetricalhistories. The components of the examination havenot been universally agreed upon. It seems intuitivethe examination should include an assessment of thebony architecture, pelvic floor muscle tone and musclemass, connective tissue support, the epithelial liningof the vagina, the size, location, and mobility of theuterus, the adnexal structures, and innervation of thepelvic floor structures.

It is important to establish the oestrogen status asoestrogen receptors are present within the lowerurinary tract [89], and are shown to influence cellproliferation [90]. Women with oestrogen deficiencymay complain of urgency and frequency and recurrenturinary tract infections may develop because of lossof urethral mucosal coaptation. In women ofreproductive age symptoms may vary with themenstrual cycle [91].

The well oestrogenised vagina has a thickenedepithelium, with transverse rugae in its lower two-thirds. The poorly-oestrogenised vagina has a thinnedepithelium with loss of transverse rugae [92]. A number

of authors have shown that vaginal pH levels aregenerally 5 or less in women with no infection and otherdefinitive signs of good oestrogen effect. The use ofa pH indicator paper may help you evaluate theoestrogen status in women with no vaginal infection[93]. The appearance of vaginal secretions maysuggest a vaginal infection; urine within the vaginasuggests genitourinary fistula, hypospadias or ectopicureter.

Bimanual examination is performed to determine thesize of the uterus and of the ovaries. Some womenhave co-existent pelvic disease which may requireattention in addition to the urinary incontinence. Whenhysterectomy or oophorectomy is indicated, there isno adverse effect on surgical success with acolposuspension procedure. Pelvic masses are rarelythe cause of urinary incontinence, and rarely doeshysterectomy by itself relieve incontinence.

Urethral diverticula are occasionally congenital butmost are acquired. They may have either a simple orcomplex sacculation. Many patients with urethraldiverticula are asymptomatic and need no treatment.Symptomatic patients report recurrent cystitis,frequency, dysuria, dyspareunia, urinary incontinenceand voiding difficulties. On clinical examination a sub-urethral mass may be palpable; the urethra is usuallytender; and, if the sacculation communicates with theurethra, it may be possible to express a purulentexudate from the urethra. Occasionally, a stone maydevelop within the diverticulum [94]

6. PELVIC ORGAN PROLAPSE

The anterior, superior, and posterior segments of thevagina should be examined for pelvic organ prolapse.The examiner may use a mirror to demonstrate thefindings to the patient; she can then confirm that theexaminer has identified the extent of prolapse thatshe experiences. If the patient indicates that shenormally has a greater amount of prolapse that youpresently see, provocative manoeuvres which normallyare associated with her symptoms may be undertaken,and the examination repeated while the patient isstanding.

Several systems for the description and classificationof prolapse have been described. This may bequantified descriptively as slight, moderate, marked[95], or first, second and third degree, or objectivelyusing the Baden and Walker halfway method [96], orthe International Continence Society Pelvic OrganProlapse Quantification (ICS POP-Q) [97], or modifiedPOP-Q [98]. In the latter, utilizing the introitus as thethreshold, six specific vaginal sites and the vaginallength are assessed using centimetres of measure-ment from the introitus. In addition, the lengths of thegenital hiatus and perineal body are measured incentimetres. Figure 1 demonstrates the summarydiagram of this quantitative system.

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A simplified technique for use of the POP-Q systemwas evaluated for inter-examiner agreement and inter-system association with the standard POP-Q examin 48 subjects. The four areas examined are theanterior and posterior vaginal walls, the apex/cuff,and the cervix. In a patient who is post-hysterectomy,only three measurements are taken: the anterior andposterior vaginal walls and the cuff scar/apex. Kappastatistics (0.86) revealed good agreement betweenexaminers using the simplified POP-Q system. Inter-system agreement was evaluated using Kendall’stau-b statistic (0.90) also indicating good agreementbetween the two classification systems [99].

The pelvic organ prolapse quantification index (POP-Q-I) has been proposed for use in the research setting,as it provides a continuous variable rather thancategorical variables. The POP-Q was modified suchthat points Aa, Ab, C, Bp, and Ap are measured. PointD is used only for the identification of patients withcervical hyperplasia. Genital hiatus, perineal body,and total vaginal length are not assessed. The POP-Q-I has not undergone rigorous validation [100,101].

The original POP-Q system has been used extensivelyin research settings for the assessment of short-andlong-term outcomes of pelvic floor surgeries [102 - 105]including the use of mesh [106-120], laparoscopicsurgery [121-123].

robotic assisted vault suspension [124], sexualdysfunction associated with pelvic organ prolapse,[125- 128], and also in community-based prevalencestudies and selected patient populations with pelvicorgan prolapse [129-138].

The POP-Q has been used in the validation of theBrazilian version of the vaginal symptoms module ofthe ICIQ, [139] and for an interviewer-administeredpelvic floor symptoms questionnaire [140].

A novel speculum has been designed to facilitate useof the POP-Q system. The top and bottom blades ofthe speculum are adjustable and are marked incentimeters from the tip to the base of the blade.[141] Figure 2.

POP-Q definitions ICS report - simplified

Pelvic organ prolapse is defined as the descent ofone or more of anterior vaginal wall, posterior vaginalwall, and apex of the vagina (cervix/uterus) or vault(cuff) after hysterectomy.

Anterior vaginal wall prolapse is defined as descentof the anterior vagina so that the urethra-vesicaljunction (a point 3cm proximal to the external urinarymeatus) or any anterior point proximal to this is lessthan 3cm above the plane of the hymen.

The well-supported anterior vaginal wall should notcross the longitudinal axis of the vaginal canal.Hypermobility of the urethra-vesical junction isdemonstrated by having the patient perform a

maximum Valsalva effort. In women with hypermobilitythe increase in intra-abdominal pressure causesdescent of the urethra-vesical junction (bladder neck).On vaginal examination there may be loss of thetransverse crease between the lower and middlethirds of the anterior vaginal wall and descent of theanterior vaginal wall. Anterolateral protrusion into thevaginal canal may represent unilateral or bilateraldetachment of the pubocervical fascia along theanterolateral vagina sulcus from its attachment to thearcus tendineus fascia pelvis (white line). Centralprotrusions of the anterior vaginal wall may representdefects in the pubocervical fascia below the trigoneand base of the bladder. Advanced prolapse of theupper anterior vaginal wall may obstruct a well-supported bladder neck.

Prolapse of the apical segment of the vagina isdefined as any descent of the vaginal cuff scar (afterhysterectomy) or cervix, below a point which is 2cmless than the total vaginal length above the plane ofthe hymen. Descent of the cervix or of the vaginalapex following hysterectomy, below the level of theischial spines is evidence of a defective vaginalsuspension mechanism. In some women, theintravaginal portion of the cervix may becomeelongated and cause the cervix to extend into thelower vaginal canal, simulating prolapse; howeverthe fundus may have good support. In other womenthe uterus may prolapse fully outside the hymen asuterine procidentia. Following hysterectomy the vaginalcuff may be well supported or may prolapse fullyoutside the hymen along with other vaginal segments.

Posterior vaginal wall prolapse is defined as anydescent of the posterior vaginal wall so that a midlinepoint on the posterior vaginal wall 3cm above thelevel of the hymen or any posterior point proximal tothis, less than 3cm above the plane of the hymen.The well-supported posterior vaginal wall should notcross the longitudinal axis of the vaginal canal.Posterior protrusions into the vaginal canal are mostcommonly caused by defects in the recto-vaginalfascia allowing protrusions of the small bowel(enterocoele) and/or rectum (rectocele). Normally,the anterior vaginal wall lies upon the posterior vaginalwall. Therefore, protrusions of the posterior vaginal wallcan affect the function of the urethra and bladderwhich lie upon the anterior vaginal wall. For example,distal loss of support in the posterior segment mayresult in a bulge which compresses the urethra andaffects voiding.

As with most new systems, clinicians and researchershave mixed opinions regarding this system. Excellentinter- and intra-observer reliability has beenestablished, although patient position may affectreproducibility in that the degree of pelvic organprolapse was higher when women were examined ina birthing chair at a 45° angle rather than in dorsallithotomy. This system has been widely adopted for

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Figure 1 : ICS POP-Q. Six sites (points Aa, Ba, C, D, Bp, and Ap), genital hiatus (gh), perineal body (pb), andtotal vaginal length (tvl)used for pelvic organ support quantitation.

Figure 2 : Speculum with adjustable blades and scale markings designed to allow easier assessment ofpelvic organ prolapse using the POP-Q system. (Diokno AC, Borodulin G. A new vaginal speculum forpelvic organ prolapse quantification (POPQ). Int Urogynecol J Pelvic Floor Dysfunct. 2005 Sep-

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pelvic organ prolapse researchers. In addition tocollecting specific centimetre measures, an ordinalstage (0-IV) can be assigned.

Absence of prolapse is categorised as stage 0 support;prolapse can be staged from stage I to stage IV. Theclinical utility of such a classification might bequestioned, since clearly some degree of descent isthe norm especially in a parous population. In a studyof 477 women attending for annual gynaecologicalexamination, Swift et al found that the average numberof positive responses to a 7-question prolapsequestionnaire was 0.27 in patients with stage 0prolapse, 0.55 for stage I, 0.77 for stage II, and 2.1for stage III. They concluded that women with prolapsewith the leading edge beyond the hymenal ring hada significantly increased likelihood of having symptoms.In a general population of Swedish women ages 20-59, the prevalence of prolapse was found to be 31%,whereas only 2% of all women had a prolapse thatreached the introitus. It might seem more reasonabletherefore to define prolapse not on the basis of anyfinding greater than stage 0, but on the basis of findingswith a significant likelihood of being associated withsymptoms.

Urinary incontinence and pelvic organ prolapse areseparate clinical entities which often coexist. Significantprotrusions of the vagina can obstruct voiding anddefecation. Surgical repair of one pelvic support defectwithout repair of concurrent asymptomatic pelvicsupport defects appears to predispose to accentuationof unrepaired defects and new symptoms. Womenwith pelvic organ prolapse may have to reduce theirprolapse in order to void. Women with pelvic organprolapse and a large PVR should be evaluated forvoiding phase dysfunction (e.g., outlet obstruction,detrusor hypotonia).

Although anatomy can be measured and assessedaccurately, reproducibly and reliably, the relationshipof these anatomic findings with functional abnormalitiesis not well understood. For example, supportabnormalities in the anterior vaginal wall are commonin vaginally parous women; however, stress urinaryincontinence is not always associated with thisanatomic alteration. Likewise, distal posterior vaginalwall support abnormalities may exist with or withoutdefecation abnormalities. The important relationshipsbetween anatomy and function are one of the mostpressing research needs in the field of physicalexamination for women with pelvic organ prolapse.

Other important research needs include the develop-ment of clinically relevant ordinal staging that moreappropriately separates meaningful prolapse fromanatomic changes following vaginal delivery. Suchrevised staging would allow a meaningful dialog aboutthe appropriate surgical indications for pelvic organprolapse and development of clinically relevantanatomic outcome measures.

7. RECTAL EXAMINATION

Digital rectal examination allows the description ofobserved and palpable anatomical abnormalities andis the easiest method of assessing pelvic floor musclefunction in children and men. In addition, rectalexamination is essential in children with urinaryincontinence to rule out faecal impaction. In all womena digital rectal examination is also performed to assesssphincter tone (both resting and active) and to detectfaecal impaction or a rectal mass.

8. ADDITIONAL BASIC EVALUATION

a) Pad tests

The objective of pad testing is to quantify the volumeof urine lost by weighing a perineal pad before andafter some type of leakage provocation. This testhas also been used in an attempt to distinguishcontinent from incontinent women. Pad tests can bedivided into short-term tests, usually performed understandardized office conditions, and long-term tests,usually performed at home for 24–48 hours. Pad testsare generally performed with a full bladder or with afixed known volume of saline instilled bladder beforebeginning the series of exercises. A pad weight gain>1 g is considered positive for a 1-hour test, and a padweight gain >4 g is positive for a 24-hour test. Thereis wide variation in the pad weight gain in incontinentwomen participating in clinical trials. Although somestudies have found high test-retest correlations in padtests [142,143]. other studies have reported low inter-subject and intra-subject reliability [144,148]. Traditionalpad testing may be negative in women with mildleakage; an alternative “paper towel test” was shownto be a simple and reliable measure of cough-relatedurine loss typical of mild stress incontinence. (149)Long-term tests are more reproducible. The correlationcoefficient between total leakage during two 24-hourpad tests is good, at 0.66 [150] and 0.82 [151] andincreased to 0.90 in one study in which two 48-hourperiods were compared. There was no correlationbetween the leakage volume found in the 48-hourtest and a standard 1-hour test.

b) Dye testing

When it has proved impossible to confirm a patient’scomplaint of urinary leakage, it may be appropriate toseek to confirm firstly that the reported discharge isin fact urinary, secondly that the leakage is extra-urethral rather than urethral, and thirdly to establishthe site of leakage. Although other imaging techniquesundoubtedly have a role in this regard, carefullyconducted dye studies should be considered.Excessive vaginal discharge or the drainage of serumfrom a pelvic haematoma postoperatively may simulatea urinary fistula. If the fluid is in sufficient quantity tobe collected, biochemical analysis of its urea contentin comparison to that of urine and serum will confirmits origin. Phenazopyridine may be used orally (200mg

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tds), or indigo carmine intravenously, to stain the urineand hence confirm the presence of a fistula. Theidentification of the site of a fistula is best carried outby the instillation of coloured dye (methylene blue orindigo carmine) into the bladder via catheter with thepatient in the lithotomy position. The traditional ‘threeswab test’ has its limitations and is not recommended;the examination is best carried out with directinspection; multiple fistulae may be located in thisway. It is important to be alert for leakage aroundthe catheter, which may spill back into the vaginacreating the impression of a fistula. It is also importantto ensure that adequate distension of the bladderoccurs as some fistulae do not leak at small volumes;conversely, some fistulae with an oblique track throughthe bladder wall may leak at small volumes, but notat capacity. If leakage of clear fluid continues after dyeinstillation a ureteric fistula is likely, and this is mosteasily confirmed by a ‘two dye test’, using Phenazo-pyridine to stain the renal urine, and methylene blueto stain bladder contents[152]

c) Pelvic floor muscle strength

Pelvic floor muscle function: can be qualitativelydefined by the tone at rest and the strength of avoluntary or reflex contraction as strong, weak orabsent or by a validated grading system (e.g. Oxford1-5). A pelvic muscle contraction may be assessedby visual inspection, by palpation, electromyographyor perineometry. Factors to be assessed includestrength, duration, displacement and repeatability.

The continence mechanisms imply that integrity ofthe levator ani and external urethral sphincter isnecessary to maintain continence [153]. It is thereforeimportant to test the contractility of these muscles.Once the patient understands how to contract thepelvic floor muscles correctly, the evaluation is carriedout during a maximum contraction [154].

STRENGTH is defined as the maximum force or tensiongenerated by a muscle or muscle group [155]. Itreflects the power, endurance and functional statusof the muscle.

WEAKNESS is defined as failure to generate theexpected force.

FATIGUE is defined as failure to maintain the expectedforce with continued or repeated contraction [156].

When considering methods/devices used to measurepelvic muscle strength, cost and availability should berecognized as important factors. Four methods ofassessment are considered here: observation, digitalpalpation, perineometry and cotton swab (Q-tip)testing.

Observation - This qualitative measure can detect anin-drawing of the anus, lifting of the posterior vaginalwall and narrowing of the vaginal introitus (females);an in-drawing of the anus and slight lifting of the penis(males).

• Advantages: Suitable for both sexes and all agegroups, where an internal evaluation may be in-appropriate. Inexpensive. Able to detect reflexcontraction with cough, and bulbo-cavernosusreflex. Observe accessory muscle activity.

• Disadvantages: Subjective. Cannot distinguishright and left sides independently. Generallyobserving activity of the superficial perinealmuscles, and assuming levatores are respondingin a like manner. Difficult to observe when thepatient is standing.

Digital palpation - Palpation of the right and leftlevator ani, per vaginam. Palpation of the perinealbody.

• Advantages: Suitable for both sexes. Inexpensive.Able to differentiate right from left. Quantitative -using modified Oxford scale or other systems[157,158]. Able to measure strength and endurance.Can detect reflex contraction with cough andpatient’s ability to hold contraction during a cough.Can be used when the patient is standing.

• Disadvantages: Subjective. Not sensitive.

Perineometer - Manometric measure of change in avaginal/anal pressure probe. Sensitivity depends onthe device.

• Advantages: Relatively inexpensive. Able tomeasure strength and endurance. Quantitative.Can be used when the patient is standing.

• Disadvantages: Unable to distinguish right fromleft. Pressure changes may be caused by increasein intra-abdominal pressure, due to co-contractionof the abdominal muscles. No ‘Gold Standard’device; different results with different probe sizesand materials [159].

Cotton swab (Q-tip) test Downward, posteriormovement of stem (measured on a goniometer) isdependent on the strength of the contraction of thepubo-coccygeus muscles, and mobility of the urethra[160].

• Advantages: Inexpensive. Can measure strengthand endurance.

• Disadvantages: Lacks sensitivity and specificity.Invasive. Females only.

The information learned from assessment of pelvicfloor muscle strength has the following practicalapplications:

1. The patient has good pelvic floor muscles that needskill training to help maintain continence. DeLanceyand associates have described ‘knack’ teaching[161,162].

2. The patient has weak muscles that are capable ofcontracting but need strength and skill training.

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An effective exercise program should increaseresting tone (Type I fibres) as well as improve theability of fast twitch (Type II) fibres to respond toincreases in intra-abdominal pressure [163].

3. The patient has no perceptible contractions andneeds further evaluation (EMG, MRI, neuro-physiologic testing) or passive contraction therapyi.e., functional electro stimulation.

Recommendations

Future research

1. Correlation of symptoms and physical findings withurodynamic and colorectal investigations, and bothbasic and complex evaluations with treatmentoutcomes.

2. The development of a clinically relevant ordinalstaging that meaningfully separates significantfrom insignificant pelvic organ prolapse.

3. Impact of surgical interventions for incontinenceon pelvic organ support, and for pelvic organprolapse on continence mechanisms.

1. CHARACTERISTICS OF MALE INCONTINENCE?

In the male patients, lower urinary tract dysfunction,and obstruction from benign prostatic enlargementpresents a multi-factorial paradigm for symptomaetiology. Lower urinary tract symptoms (LUTS) inmen have a significant effect on quality of life (QOL),as compared with the unaffected general population.[163]. Several epidemiological reports demonstratedthat overactive bladder (OAB) syndrome also increasewith age in men [164,165]. Older age and highergrade of obstruction has been reported in men withbladder outlet obstruction and idiopathic detrusoroveractivity [166].

In the NOBLE study, a different sex-specific patternemerged for OAB with or without urge incontinence[165]. The prevalence of OAB with urge incontinencedisplays a steeper age-related increase among womenthan among men and the gender difference isstatistically significant. In women, OAB with urgeincontinence increased more than nine-fold from 2.0% in those 18-24 years of age to 19.1% among those65-74 years of age. In contrast, a substantial increasein prevalence of OAB with urge incontinence amongmen did not occur until 65 years of age, reaching8.2% for ages 65-74 years and 10.2% for those 75years and older. In men, OAB without urgeincontinence increased approximately three-fold, from8.5% below 45 years of age to 21.8% after 55 yearsof age, whereas OAB without urge incontinencegradually increased in women less than 44 years ofage and reached a plateau in women over the age of44 years.

‘Prevalence ratios for OAB with urge incontinenceand for OAB without incontinence were significantlyelevated for men who self-reported with a history ofprostate problems. Thus, the evaluation of men withsymptoms of OAB syndrome depends on theidentification and assessment of lower urinary tractobstruction that may be a cause (in part or in entirety)of the presenting symptoms.

The aetiology of obstructive symptoms may vary, frombenign prostatic hyperplasia (BPH), urethral stricture,primary bladder neck dysfunction, or abnormal voidingdynamics of detrusor. Chronic prostatic painsyndromes (e.g. non-bacterial chronic prostatitis) andother pelvic floor dysfunctions can also present with

V. THE MALE PATIENT

1. Although the value of individual urinary symptomsand symptom complexes in predicting theunderlying abnormality of lower urinary tractfunction is not high, a significant proportion ofwomen with stress incontinence can be correctlydiagnosed from basic evaluation only. GradeC

2. The frequency/volume chart or urinary diary isthe most effective additional test for usealongside basic evaluation in primary orsecondary care.Grade C

3. In assessing patients with urinary or faecalincontinence, the clinician should consider allaspects of pelvic floor dysfunction, i.e. urinary,bowel, prolapse, and sexual function. Grade D

4. Prolapse visible at the introitus or below may beassociated with symptoms (Level 3) Indescribing patients with pelvic organ prolapse,one of the several systems available forclassification and quantification of urethralhypermobility and pelvic prolapse should beemployed. The ICS recommends the POP-Q.(Grade D). In addition, an assessment of pelvicfloor identification and strength should beconsidered. Grade D

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a component of symptoms compatible with OAB. Inyounger men, primary bladder neck dysfunction is acommon cause of LUTS, with or without pelvic pain[167]. Functional abnormalities of striated sphincterrelaxation may also occur in young men [168] Thecomplexity of the presenting symptoms and the variousdifferential diagnoses mandate a thorough basicassessment of the lower urinary tract in men to planoptimal therapeutic intervention.

Another important issue in male patients isincontinence after surgery or intervention for BPOand prostate cancer. A survey in England of 5276patients who had undergone TURP found that one-third of men (n=1759 men) who were continent beforesurgery reported some incontinence 3 months postTURP [169]. Recently many minimally invasive andsurgical techniques in management of BPO havebeen reported. A systematic review of the literatureshowed Urinary incontinence is more often seenfollowing TURP (1.4%). The rate of urinaryincontinence after other techniques are as follows:HIFU; 0.0%, ILCP: 0.1%, TUMT: 0.1%, TUNA: 0.0%,TUVP: 0.9%, VLAP: 0.2%, HoLEP: 1.2% [170].

It has been reported that after permanent prostatebrachytherapy, urinary incontinence was observed 0-19% [171]. After radical prostatectomy, Donnellan etal reported that 6 % of men were mildly incontinent,6 % were moderately incontinent and 4 % wereseverely incontinent at 1 year after surgery [172].Carson et al. reported that incontinence occurs in 0.5to 1.0% of all patients undergoing prostatectomy forbenign disease; high rates (5 to 30%) are associatedwith radical prostatectomy [173].

Although prostate-ctomy has a clinically significantbeneficial effect on LUTS with significant improvementsof AUA symptom index and flow rate, [174, 175] urinaryleakage can have a major impact on QOL. Greaterdegrees of urine loss are correlated with greater botherand more significant life-style changes [172]. AMedicare survey by Fowler showed that in 1072patients, more than half of the patients with urinaryleakage considered it to be a medium or large problem[176]. In spite of these findings, many investigatorshave been encouraged by overall patient satisfactionwith surgery and patients willingness to undergosurgery again, if faced with the same situation [176].

In the immediate postoperative period, stress andurge incontinence are common. This has beenattributed to varying degree of oedema and inflam-mation present in the healing prostatic urethra. Themajority of men achieve continence without invasiveintervention following total prostatectomy. Finalcontinence status should be measured using self-administrated disease specific instruments at 24months after operation [176]. And no factors (age,severity of LUTS, Gleason score, bilateral nervesparing surgery and estimated blood loss) were

identified that predicted early return of continence[172].

Post-prostatectomy incontinence may be caused bysphincter malfunction and/or bladder dysfunction.[177,178]. Urinary control in the adult male dependson integrity of both the internal and external sphincters.During TURP, the internal sphincter mechanism isvirtually destroyed, and in some cases, the externalsphincter is also damaged. Thus post-prostatectomystress incontinence may result.

In a recent study of patients undergoing radicalprostatectomy that specifically evaluated detrusordysfunction [179] de novo detrusor underactivity andimpaired or poor compliance, presumed to be aconsequence of bladder denervation, occurred in alimited proportion of patients (28.6% and 18.4%respectively), and this bladder dysfunction resolvedin the majority within 8 months. Detrusor underactivityand decreased bladder compliance are also pre-existing conditions in about 30% and 20% of patients.

The conditions relate to the presence of BOO, and theydo not appear to be influenced by prostatectomy.Persistent detrusor overactivity after obstruction reliefis probably related to concomitant sphincter deficiencyand stress urinary incontinence, which increaseafferent nerve activity of the proximal urethra andinduce involuntary detrusor contractions [180].

Obstruction after prostatectomy, resulting from ananastomotic stricture or residual prostatic tissue (postTUR-P), may also play an important role in thedevelopment of post-prostatectomy incontinence.Obstructing stricture often causes increase in post-voidresidual urine, resulting in the urinary leakage and/ora weak urinary stream. It has been reported that theanastomotic stricture treatment rates after radicalprostatectomy are 16% to 33% [181,182].

2. GENERAL MEDICAL HISTORY

The medical history should focus on the urinary tract,previous surgical and radiation therapy history, medicalcondition and symptoms that may cause to bladderdysfunction or polyuria, familial history of prostatediseases (BPH and cancer), and a review of sexualand bowel habits. Urinary incontinence is rare in menwithout a history of previous trauma or prostatic orpelvic surgery; therefore, neurogenic bladderdysfunction must be considered in men with no historyof surgery or trauma. A critical assessment of currentmedications is recommended to exclude the effectsof any pharmacological agents on lower urinary tractfunction.

In the evaluation of the patients with post-prostate-ctomy incontinence, an important aspect of the historyshould be a description of the type and severity ofincontinence and precipitating events, Severity maybe determined by the number of episodes per day, the

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need for protection (e.g., pads, penile clamp, externalcatheter), and the impact of incontinence on activitiesof daily living. Bladder diaries and pad tests canquantify severity. The presence of other LUTS suchas OAB and decreased force of urinary stream shouldbe determined.

3. SYMPTOM ASSESSMENT

Diagnostic evaluation of men with LUTS depends onan initial estimation of subjective bother and objectivedata on bladder emptying. Because the occurrenceof LUTS does not necessarily indicate concomitantprostate enlargement and/or obstruction, specificmodalities should be used to ascertain the potentialfor the aetiologic role of these entities. A bladder diarymay be useful in almost all male patients, especiallyin those with OAB. Bladder diary completion by thepatient provides useful evidence about the normalurinary habits of the patient, including giving someestimate of bladder capacity and diurnal and nocturnalfrequency, urgency and incontinence. The dataobtained from frequency-volume chart provide a strongcorrelation to cystometric capacities and arereasonably immune to the effect of detrusor overactivityin men with LUTS [183]

A variety of symptom scores have been described toassess male patients with LUTS. In men, the AmericanUrological Association symptom score for BPH (AUA-7) is most commonly used in North America forassessment of subjective symptoms. However, equallyreproducible data can be obtained from theInternational Prostate Symptom Score (IPSS), theICSmale questionnaire (now renamed theICIQMLUTS, long and short forms, as part of the ICIQmodular questionnaire: www.iciq.net).

The IPSS has been the most widely used (in manycountries and languages), but neglects the symptomof urgency incontinence, a symptom that producessignificant bother. The ICIQMLUTS (ICSmale-SF) isslightly longer, but takes into account the symptom ofurgency incontinence, and in fact may be divided intovoiding and incontinence subscores. To date, it hasnot been as widely used as the IPSS, but may seemore widespread use as part of the ICIQ ModularQuestionnaire.

Among LUTS, urgency, nocturia, and hesitancy aremost bothersome, whereas weak stream, urgency,and frequency are the most prevalent in pooledpopulations being evaluated for BPH [184] Post-micturition dribbling is often provoked by an obstructingdisease such as BPH or urethral stricture but canalso be a symptom of a urethral diverticulum. Post-void residual urine volume and careful palpation of thegenitalia are recommended in these patients.

To determine the cause of post-prostatectomyincontinence, many studies have stressed the lack

of reliability of symptoms and emphasised theimportant role of urodynamic testing [185,186].Nevertheless, valuable information can be gainedfrom a careful history with regard to incontinence,especially when related to sphincter dysfunction. Thesymptom of stress incontinence is highly predictive ofthe presence of sphincter dysfunction. Chao and Mayofound that 67 of 71 men with post-prostatectomyincontinence secondary to sphincteric dysfunctioncomplained of the symptom of stress incontinence[187]. Similarly, Ficazzola and Nitti found 95% positivepredictive value and a 100 % negative predictive valuefor symptom of stress incontinence [177]. Urgeincontinence as a predictor of bladder dysfunctiondose not seem to be as valuable, and the presenceof bladder dysfunction cannot be determinedaccurately without urodynamic testing [177,187].

4. PHYSICAL EXAMINATION

A general physical examination with specific attentionto the presence or absence of a distended bladder,excoriation of the genitals secondary to urinaryincontinence, evidence of urethral discharge and afocused neurological examination is also highlyrecommended.

The assessment and treatment algorithm focuses onthe abdominal examination, digital rectal examination(DRE) and neurological testing of the perineum andlower extremities. In a patient suspected of neurogenicbladder, evaluation of perineal sensation and lowerextremity neuromuscular function, and anal sphinctertone, which is often decreased in neurogenic patients[188] is important. A focused neurogenic examinationshould also assess the patient’s general mental statusand ambulatory status. The examination should alsoinclude external genitalia, location of the urethralmeatus, retractability of the foreskin and evidence ofcongenital malformation. Abdominal palpation shouldbe performed to evaluate bladder distension, especiallyin elderly incontinent men, who may have overflowleakage due to obstruction. In patients suspected ofurinary retention, post-void residual volume (PVR)should be measured. The patients with incontinenceshould be asked to cough and to perform a Valsalvamanoeuvre so that the presence of stress incontinencecan be ascertained.

DRE should include palpation of the prostate to assesssize, symmetry and consistency of the gland and itsrelation to the pelvic sidewall and the rectum. Thelocally advanced prostatic cancer can also produceOAB-like symptoms. DRE may exclude prostaticcancer, although its specify and sensitivity is low [189]DRE tends to underestimate the true prostatic size:if the prostate feels large by DRE, it usually also isfound to be enlarged by ultrasound or othermeasurement technique [190, 191]. Prostate volumehas been recently associated with the risk of BPH

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progression [192] and response to treatment [193].It has been reported that men with BPH with idiopathicdetrusor overactivity showed a significantly higherincidence (54%) of intravesical protrusion of theprostate [194]. This finding suggests that intravesicalprotrusion may in some way increase afferent impulsesfrom the prostate and alter the stability status of thebladder. Occasionally tumours of the anal canal canbe diagnosed while performing DRE of the prostate.

Incontinence combined with evacuation problems ina man often requires further investigation includingurodynamics. It may be helpful to ask these patientsto measure the voiding time for the first voided 100ml on several different occasions.

5. URINALYSIS AND URINE CYTOLOGY

Bladder cancer, carcinoma in situ of the bladder,urinary tract infections, urethral strictures, and bladderstones can cause OAB-like symptoms in aged men.Although haematuria or pyuria is not universallypresent in those conditions, urinalysis is important torule out these diseases. Urinalysis is not a single test,complete urinalysis includes physical, chemical, andmicroscopic examinations. Dipstick urinalysis iscertainly convenient but false-positive and falsenegative results may occur. It is considered aninexpensive diagnostic test able to identify patients withurinary tract infection as indicated by the presence ofleucocyte esterases and nitrites. A substantialproportion of older patients with chronic OAB-likesymptoms have significant bacteriuria, sometimesaccompanied by pyuria. In men, recent urinary tractinfections were associated with OAB without urgeincontinence (prevalence ration=2.9; 95% CI: 1.6-5.0) [165].

However, infection may exist in the absence of pyuriaand, in the elderly population, pyuria may develop inthe absence of urinary tract infection. Microscopichaematuria can be easily identified by dipstickingbecause of the presence of haemoglobin. Thedetection of haematuria is important because thecondition is associated with a 4-5% risk of diagnosingurological disorder or malignancy within 3 years.Because of the high prevalence of urinary tractinfection and the increase of LUTS in the presenceof urinary tract infection, all guidelines on themanagement of patients with LUTS suggestive ofBPO, and urinary incontinence, endorse the use ofurinalysis in primary care management [195,196].

Urine cytology is also recommended in male patientswith haematuria and a predominance of storagesymptoms, especially with a history of smoking orother factors, to aid in the diagnosis of bladdercarcinoma in situ and bladder cancer

6. MEASUREMENT OF THE SERUM CREATININE

Epidemiological studies in community dwelling men

have shown the absence of any association betweenBPO / BPE / BPO and chronic kidney disease [197]suggesting that screening for renal function is notjustified in male patients Recently, data from theMTOPS study showed that the risk of developing denovo renal failure in men with LUTS is low (less than1 %) suggesting that is not necessary to monitor renalfunction in patients with LUTS / BPO [197].

7. MEASUREMENT OF THE SERUM PROSTATE-SPECIFIC ANTIGEN (PSA)

In most patients, a normal DRE may be sufficient toexclude locally advanced cancer as a cause of LUTSor OAB. There is no consensus as to the measurementof prostate specific antigen (PSA) in patients withLUTS. The rationale for measuring PSA is twofold:to screen for prostate cancer [198] and to measure aparameter with prognostic value for the progressionof BPH and the response to treatment [192,193].Because prostatic cancer is one of the potential causesof LUTS or OAB in men, PSA (together with DRE) isa relatively sensitive way to exclude prostatic canceras a diagnosis [199,200].

However, it is important to understand that about 25%of men with BPH have a serum PSA greater than 4ng/ml. Because of the overlap between serum PSAvalues in men with BPH and those with clinicallylocalised prostate cancer, other parameters (PSAvelocity, free/total PSA ratio, complexed PSA andPSA density) will assist diagnostic specificity [201,202]. It has been suggested that a relationship betweeninitial PSA level and subsequent prostate cancerdetection with a stepwise increase in cancer detectionrate (from <1% to 58%) in patients with <1.0 ng/ml,1.1-2.5, 2.6-4.0, 4-1-10.0 and >10 ng/ml PSA valuein over 26.000 patients enrolled in a screeningprogramme [203]. In addition, Thompson reporteddata on prostate cancer prevalence from the prostatecancer prevention trial [204] confirming a stepwiseincrease in the risk of having a prostate cancer inpatients with serum PSA from 0.5 to 4.0 ng/ml butshowing the limitation of the current threshold of 4.0ng/ml. Change of PSA threshold from 4.0 to 2.0 ng/mlhas been proposed but currently no consensus exists[205]. PSA measurement is recommended in menwith LUTS and a life expectancy of over 10 years inwhom the diagnosis of prostate cancer would changethe management of patient’s symptoms.

It has been reported that the role of IPSS score in theassessment of BOO is questionable, and that thegrade of obstruction is more related to prostate volume,PVR, and Qmax [44]. It has been demonstrated thatmoderate-to-severe LUTS in men can result in urinaryretention. The incidence of retention in men withuntreated LUTS in community-based trials is 6.8 per1000 during longitudinal follow-up of 4 years [206]. Ifonly patients with moderate-to-severe symptoms areconsidered, the rate of retention increases to 25 per1000 [207] Moreover, in considering men with weak

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urine flow, symptoms, and increased age, withouturodynamic evaluation, other parameters becomeindependently predictive of the development of acuteurinary retention. In a meta-analysis of predictors ofretention in pooled groups of placebo patients fromclinical trials of men with LUTS undergoing activeinterventions (4300 patients), Roehrborn et al. foundprostate-specific antigen and prostate volume to bestrong independent predictors of urinary retention andthe need for surgery in men with LUTS followed uplongitudinally in clinical trials [191,208].

Recently, Laniado et al (2004) [209] have also testedthe hypothesis that PSA level could be used to predictthe presence or absence of BOO, evaluated bypressure flow studies. In patients with LUTS, those witha PSA more than 4 ng/ml are significantly more likelyto have some degree of BOO. Conversely patients withPSA less than 2 ng/ml have a 33% risk of BOO.

Therefore, on the basis of these trials, untreated LUTSmay place the male patient at risk for potential clinicaldeterioration. Thus, periodical measurements of PVRare recommended in such patients.

Recommendations

Future research

1. Improve the understanding of the underlyingpathophysiology and contributory clinical factorsinvolved in the development and treatment ofdetrusor overactivity in the male patient, especiallyin differentiating the condition from female patients.

2. Development of simple, non-invasive, cost-effectivemethods to determine the contribution of bladderstorage and bladder emptying abnormalities inmale patients.

Basic assessment of faecal incontinence focuses ondetermining:

1. Type of incontinence

2. Functional limitations resulting from incontinence

3. Cause(s) of incontinence

1. HISTORY

History gathering requires particular tact in dealingwith this taboo symptom, but also a willingness to askdirect questions about the complaint. In taking ahistory, the necessary first step is to determine thenature of the incontinence being experienced by thepatient. True faecal incontinence must be differentiatedfrom conditions that cause seepage such as externalhaemorrhoids, fistulas, low rectal or anal tumours,and poor perineal hygiene.

Diagnostic administration of an enema may be usefulin this respect; retention of the enema suggests thatthe patient does not have clinically significant faecalincontinence. This serves to both clarify the patient’shistory, but also begins to suggest the anatomicaldeficit causing the incontinence (see below). The keyimportance of the history and examination is to identifyany conditions that are amenable to condition specificmanagement – these are cited in logical sequence inthe text below, and listed in the recommendation box.

a) Type of incontinence

• Flatus incontinence – incontinence of flatus due toinability to differentiate gas from solid or liquid

• Passive leakage – involuntary soiling of liquid orsolid stool without patient awareness

• Urge incontinence – inability to defer defaecationonce the urge is perceived, for long enough to finda toilet

The first two forms are primarily related to internalanal sphincter dysfunction, the latter form due toexternal anal sphincter dysfunction. (Grade B) [210].Soiling after defaecation is typically related to eithera defect in the internal sphincter or poor “snappingshut” of the external sphincter after voiding. (GradeC) [211]. It is also important to determine if theincontinence is for solid or only liquid stool; if for liquidstool, the possibility of a colonic cause of diarrhoeaneeds to be considered. (Grade B) [212].

I. FAECAL INCONTINENCEASSESSMENT

5A- B. INITIAL ASSESSMENT OFFAECAL INCONTINENCE

1. Male patients differ from female patients in thepresentation of LUTS. The incidence of OABwet is lower until the 7th decade. (Level 2)

2. Urinary stress incontinence is primarilyassociated with surgery of the prostate in malepatients. (Level 2)

3. Disorders of bladder emptying from benignprostatic enlargement should be consideredbefore treating male patients for OAB symptoms.(Level 2) ((Grade B).

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b) Functional status

After confirming the nature of faecal incontinence, itis necessary to determine the impact of the conditionon a patient’s lifestyle and quality of life. Thisassessment offers the opportunity to both empathisewith the patient and to understand the pertinentemotional and social factors in the manifestation ofsymptoms. The history should include:

• Need to wear tissues or pads in underwear –indication of severity. (Grade B) [213-215]

• Degree of soiling of tissues, pads or underwear.(Grade C) [213,215]

• Duration, frequency and timing of incontinenceepisodes – indication of severity. (Grade C)[213,216]

Ability to wear clothing of choice, eat food of choice,participate in work and social activity. (Grade C)[213,216]

Severity of faecal incontinence can be classified as:

• minor - if faecal seepage occurs less than once amonth,

• moderate - if there is incontinence to solids morethan once a month or liquids more than once aweek, and

• severe - if there is loss of control of solids severaltimes a week or liquids on a daily basis.

An alternative classification grades continence asfollows:

Grade 1: Complete

Grade 2: Incontinence of flatus

Grade 3: Incontinence of flatus and liquid stools

Grade 4: Incontinence of flatus, liquid stools, and solidstools.

c) Aetiology

A careful, thorough history and full physicalexamination are essential and will identify the majorityof causes of faecal incontinence. The history shouldinclude:

• Dietary history – in particular excess ingestion ofsorbitol and caffeine. (Grade C) [217]

• Medical history – particularly anti-anginals, anti-hypertensives which may reduce sphincter tone,and ferrous sulphate or antacids which mayprovoke diarrhoea. (Grade C) [214]

• Presence of benign anal disease – haemorrhoids,fistula, anal warts. (Grade B) [218]

• History of chronic straining – suggestive of rectalmucosal prolapse, an important cause of internalanal sphincter dysfunction. (Grade B) [219]

• Obstetric history – particularly with regard to: (GradeB) [220,221]

- number of vaginal deliveries

- need for forceps or Ventouse

- birth weights

- duration of second stage(s)

- episiotomy

• Perianal surgery history – particularly: (Grade B)[222]

• Anal fissure surgery (sphincterotomy or analstretch)

• Fistula surgery

• Low colonic resection surgery

• History of pelvic radiation – risk of radiation proctitis(causing heightened rectal contractions) andinternal anal sphincter radiation damage (GradeB) [223]

• Symptoms of other pelvic floor problems (urinaryincontinence and pelvic organ prolapse), whichhave similar risk factors should be elicited (GradeC) [224])

• Cognitive assessment in appropriate patients(Grade C) [225]

2. EXAMINATION

Examination is focussed towards the detection ofevidence of incontinence and identifying the cause ofincontinence.

a) Evidence of incontinence

Physical examination should include inspection ofunderclothing for soiling and staining by stool, pus, ormucus.

Perianal skin should be examined for irritation andexcoriation due to over-zealous hygiene. Perianalinspection should include attempts to identify thefollowing: (Grade B) [215,226,227]

• Perianal excoriation or erythema – suggestive ofchronic passive soiling

• A patulous anus or one which gapes on gentletraction of the anal verge

• A “keyhole” deformity of the anal canal – suggestinga persisting sphincter defect

b) Cause of incontinence

Inspection may reveal scars from previousepisiotomies or obstetric tears. Abnormalities at theanal verge from previous surgery or a gaping anussuggestive of marked loss of function may be present.Perianal inspection should identify: (Grade C) [215,226,227]

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• Scars from previous surgery

• Perianal disease – prolapsing haemorrhoids, fistula,anal warts

• Absence of perineal body – suggestive of obstetrictrauma; at its worst this may manifest as a cloacaldeformity

• Inspection for sphincter asymmetry whilst patientcontracts sphincter – suggestive of regionalsphincter defect

• Function of the puborectalis muscle (palpable atthe anorectal junction) is assessed by asking thepatient to squeeze the sphincter at which time thepuborectalis should push the examiner’s fingeranteriorly.

Digital examination should identify: (Grade C)[210,226,227].

• Rectal content – if faecal impaction is present thiscould explain incontinence

• Resting tone – indicative of internal anal sphincterfunction

• Voluntary and involuntary squeeze pressure –indicative of external anal sphincter function andpotential function, respectively. The latter is elicitedmost commonly by asking the patient to coughwhile assessing sphincter tone – a cough causesa near-maximal external sphincter contraction(analogous to the guarding reflex in the bladder)

• Regional sphincter defects – detected asasymmetry

• A thickened sphincter – suggestive of chronicstraining and occult rectal mucosal prolapse

If suggested by earlier findings (history of straining,thickened sphincter), the patient should be asked tosit on a commode and attempt voiding – the perineumshould then be inspected for evidence of a rectalmucosal or full thickness prolapse (Grade C) [219]

Proctoscopy or rectosigmoidoscopy with a rigidinstrument is a bedside test of value in excludingpotentially treatable causes of faecal incontinence:

• Anal tumours or polyps

• Low rectal cancers or adenoma (Grade B) [228].

• Solitary rectal ulcer syndrome – a functionaldisorder of evacuation, in which repeated strainingat stool and rectal self-digitation results in anulcerated area of the anterior rectal wall (Grade)[229].

Vaginal examination using a Simms speculum mayshow a rectocele, cystocele and/or uterine prolapse,all of which may contribute to developing faecal

incontinence (Grade C) [230].

Physiological and complimentary radiological testsare used to confirm clinical suspicions and provideobjective data on the function of the anorectum. Pelvicfloor dysfunction is a complex problem and multipletests may be needed based on the initial findings andcomplexity of the planned intervention.

KEY RECOMMENDATIONS FAECALINCONTINENCE

• It is essential to perform a baseline assessmentcomprising:

- focussed medical history

- a general examination

- an anorectal examination

a cognitive assessment (when appropriate)

• The following conditions should be specificallyassessed for as they may be amenable to definitivetreatment:

- rectal prolapse or third-degree haemorrhoids

- faecal loading

- potentially treatable causes of diarrhoea (eginflammatory bowel disease and irritable bowelsyndrome, infection, adenomas)

- acute anal sphincter injury including obstetric andother trauma

- acute disc prolapse/cauda equina syndrome

Future research

• Development and validation of a digital (finger)instrument to assess anal sphincter function(analogous to the instrument in existence forurological assessment of pelvic floor musculature).

• Development of a psychometrically valid andreproducible instrument to assess quality of life infaecal incontinence.

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In the first three International Consultations onIncontinence reports, the impact of incontinence onquality of life (QoL) and methods of measuring thesefactors were described with questionnaire recom-mendations for use in research and clinical practice[1, 2]. This triennial update is a departure from previousreports in that the scope of this chapter encompassesnot only quality of life, but all patient-reported outcomes(PRO); and will also include a review of screeningtools, not just outcome measures. Additionally, thischapter will extend and update the prior literaturereviews of PROs, broaden the review to include lowerurinary tract (LUTS) and bowel incontinence outcomesmeasures, and provide recommendations forquestionnaire selection for use in clinical practice andresearch. In addition, this summary will review thepurpose and content of the ICI questionnaire (ICIQ)modules. Given the burgeoning literature in this area,a complete review of all studies with PROs will not beprovided, but rather PRO highlights will be included.

The expansion in scope of this review to include alltypes of patient reported outcomes (PRO) is animportant step in recognising the inherent conceptualdifferences of various PROs each with differentassessment goals. A PRO is an objective assessmentof the patient’s subjective experience and can includeaspects of the patient’s health. PROs measure differentaspects of disease and therapeutic impact such as:symptom frequency or symptom bother, health-relatedquality of life (HRQL), treatment satisfaction, or workproductivity measures (Figure 1). An essentialcomponent of selecting a PRO for use is to ensure thatthe selected PRO is consistent with the objective ofthe study or clinical purpose. For example, if the goalis to assess treatment satisfaction, then a treatmentsatisfaction measure should be incorporated into thestudy design or as a clinical outcome. The matchingof appropriate PRO selection with one’s desired

outcomes is critical to success when assessing PRO’sand will be reviewed further in this chapter.

Ultimately, the last decade has been one of tremen-dous growth in the area of PROs with influences fromscientific and regulatory communities. As such, the ICIwill endeavour to continually update the recom-mendations it offers on the basis of emerging data andpublished evidence based on the sound and rigidrecommendations of the previous three reviews.

A number of different electronic databases weresearched, limited to adults over the age of 18 yearsand human studies from January 2004 to June 2008,including Pub-Med, Medline, PsychInfo, theLOCATORplus database for books, serial titles andaudiovisuals, the Cochrane Library for randomisedcontrolled trials, and the NLM Gateway database.The following keywords were used separately and/or

LITERATURE SEARCH STRATEGY

INTRODUCTION

Committee 5 B

Patient-Reported OutcomeAssessment

Figure 1 : Patient-Reported Outcomes AssessmentAreas. Burke L, Evidence Review Branch DDMAC,FDA; DIA Workshop on pharmacoeconomic andQuality of Life Labeling and Marketing Claims NewOrleans October 3, 2000

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in combination: “urinary incontinence”, “urinarysymptoms”, “urgency”, “overactive bladder”, “stressincontinence”, “incontinence”, “questionnaire”,“epidemiology”, “prostate”, “prolapse”, “fecal”, “faecal”,“bowel”, “anal” and “quality of life”, “sexual” and “healthutilities”. Questionnaires identified in previous ICIreports were also searched in PubMed and Medline.

Incontinence and other lower urinary tract symptoms(LUTS) as well as bowel problems and their impacton patients and their lives can be assessed in anumber of ways. Traditionally, the clinical history hasbeen used to gain a summary view of the symptomsexperienced by patients and in some cases the impacton their lives. Increasingly however, patient-completedmethods of measuring incontinence and LUTS arebeing used, including voiding diaries and question-naires.

Patient self-completed questionnaires or patientreported outcomes (PROs) represent the mostimportant clinical review of symptom impact andtreatment benefit from a patient perspective. PROsprovide a method for the standardised collection ofdata, or an objective assessment of a subjective

phenomenon, from patients relating to incontinence,other LUTS, and bowel problems. Clinicians’ assess-ments of patients’ outcomes have often been shownto underestimate the degree of bother perceived bypatients, and to focus on issues of lesser importanceto patients [3-6].

PRO questionnaires can be used to record thepresence and severity of urinary symptoms includingincontinence, as well as the impact of symptoms oneveryday activities and health-related quality of life(HRQL). To ensure that the results obtained withPROs are clinically useful, data must be gatheredusing valid and reliable instruments. Questionnairedesign and development is not a simple process.Developing such instruments requires a multistep,structured process that incorporates cognitivepsychology, psychometric theory, and patient andclinician input. The process begins by determiningthe intent and purpose of the PRO and culminates instudies that demonstrate the measure’s validity,reliability, and responsiveness. The specific stepsrequired for developing a PRO questionnaire areoutlined in the following section and are showndiagrammatically in Figure 2.

The development of a PRO is a rigorous, scientificprocess to provide confidence that the PRO ismeasuring what it is intended to measure, that it doesthis reliably, and is appropriate for use in the patient

I. PRO QUESTIONNAIREDEVELOPMENT AND VALIDATION5B- A. THE MEASUREMENT OF

PATIENT-REPORTEDOUTCOMES (PROS) OF

INCONTINENCE, OTHER LOWERURINARY TRACT SYMPTOMS,

AND BOWEL PROBLEMS

Figure 2 : The development of a patient reported outcome is a multistep process. Food & Drug Administration(3). Guidance for industry - patient-reported outcome measures: Use in medical product development tosupport labeling claims. Silver Spring, MD: FDA; February 2006.

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or population group under investigation. The finalinstrument must have demonstrated validity andreliability in the intended target population. PROsneed to be developed with patient and clinician inputand have the psychometric, or measurement,properties of the PRO evaluated to determine that itis a valid outcome meaure. To be a useful measure-ment tool, a PRO instrument must also be easy toadminister, reliable, and valid. Only PROs that haveundergone this process and have published validationdata are discussed in this chapter.

1. DETERMINING QUESTIONNAIRE INTENT AND PURPOSE

The first task in developing a PRO measure is todetermine why the instrument is needed. Given thecurrent number of disease-specific questionnairesavailable in the field of incontinence and related pelvicdisorders, a new PRO measure must fill a need thathas not already been met by an existing instrument.Once the need for the measure is recognised, itspurpose and clinical usefulness need to be consideredbecause the purpose dictates the validation designprocess. For example, a symptom- and a treatment-satisfaction measure would be developed andvalidated differently because the outcome is different.

The development stage would focus on the outcomeof interest (eg, symptoms patients experience andthe significance of each symptom, or what issuespatients consider when determining how satisfiedthey are with treatment) with the items derived directlyrelating to the outcome of interest. Validation effortswould include designing a study focused on theoutcome of interest with the appropriate patientinclusion/exclusion criteria to enhance generalisabilitywhile maintaining internal consistency and providingopportunities to test—at a minimum—reliability andconstruct validity.

2. DEVELOPING THE ITEMS

Designing a clinically useful PRO measure involvesmore than just developing a series of questions. Inaddition to clinician input and literature review,questionnaire items should be generated from patientinput. This is obtained through focus groups or one-on-one interviews to provide qualitative data on issuespertinent to patients and to identify the words patientsuse to describe their symptoms or disease impact.Focus groups and one-to-one interviews should becarefully planned to address the goals of thequestionnaire being developed. For example, if ameasure is intended to assess symptom bother,interview questions should pertain to the patient’ssymptom experience. Importantly, rather than usingclinical terminology which patients may notcomprehend, the words used during the focus groupsor interviews should be common to patients. Afteritems are generated, the newly drafted questionnaire

should be reviewed by other patients and experts toensure its readability and content validity.

An alternative approach to questionnaire developmentis to adapt an existing measure to meet the needs ofthe desired questionnaire. Although no patient inputis required at the outset when adapting an existinginstrument, patients need to be involved after thequestionnaire is adapted to ensure that the revisedmeasure is pertinent to the population of interest.Also, the adapted questionnaire must be validatedon its own in the target population; the validity of theoriginal questionnaire does not apply to an adaptedmeasure.

For newly developed and adapted questionnaires,think-out-loud interviews or cognitive debriefinginterviews should be used to ascertain the correctnessand validity of the revised questionnaire. In a think-out-loud interview, patients are asked to review aquestion and describe what they are thinking as theycognitively process the question; the patients thinkout loud about what the question means to them. Fora cognitive debriefing approach, patients review andrespond to the questionnaire items, then areinterviewed about what each item meant to them asthey completed the questionnaire. Both approachesprovide information about what patients consider whenresponding to each question.

3. DETERMINING THE MODE OFADMINISTRATION OF A QUESTIONNAIRE

Once items have been generated, the mode ofadministration must be considered. Will the measurebe completed by the patient (ie, self-administered) oradministered by an interviewer (ie, interviewer-administered)? How the questionnaire will becompleted needs to be determined before thevalidation stage because mode of administration canaffect patient responses. For highly personal or intimatequestions, a self-administered questionnaire isrecommended to avoid response bias. Questionnairesthat are self-administered are preferable to interviewer-administered questionnaires because the datacollection burden is reduced and patients are morelikely to provide unbiased information on self-administered questionnaires. Importantly, if aquestionnaire has been validated for a particular modeof administration, this does not make the questionnairevalid for all modes of administration. Each mode ofadministration should be validated separately.

4. QUESTIONNAIRES’ PSYCHOMETRIC PROPERTIES

All PRO measures must demonstrate reliability, validity,and responsiveness, which are described in detailbelow. This can be accomplished in several ways:

1. Perform a stand-alone cross-sectional study tovalidate the questionnaire in the patient populationfor which it was designed;

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2. Administer the untested questionnaire in a clinicaltrial and use the baseline data to performpsychometric validation (the end-of-study data canalso be used to evaluate responsiveness); or

3. Perform a stand-alone longitudinal study with anintervention to determine the instrument’spsychometric performance and responsiveness ina non-clinical trial setting.

The following psychometric properties must be testedfor and demonstrated in a validated questionnaire.

Reliability refers to the ability of a measure to producesimilar results when assessments are repeated (ie, isthe measure reproducible?) [4, 5]. Reliability is criticalto ensure that change detected by the measure isdue to the treatment or intervention and not due tomeasurement error [6]. One measure of reliability isthe questionnaire’s internal consistency, whichindicates how well individual items within the samedomain (or subscale) correlate [7]. Cronbach’s alphacoefficient is used to assess internal consistencyreliability, with higher alphas indicating greatercorrelation [6]. Typically, Cronbach’s alpha should begreater than 0.70 to indicate good internal consistencyreliability [6, 7]. If the item-to-total alpha is less than0.20, the question should be removed or rewritten[4].

Test-retest reliability, or reproducibility, indicateshow well results can be reproduced with repeatedtesting. To assess test-retest reliability, the samepatient completes the questionnaire more than once,at baseline and again after a period of time duringwhich the impact of symptoms is unlikely to change(e.g., a few days or weeks) [4, 6, 7]. The Pearsoncorrelation coefficient and intraclass correlationcoefficient are used to demonstrate reproducibility.For group data, a Pearson correlation coefficient oran intraclass correlation coefficient of at least 0.70demonstrate good test-retest reliability [6, 7].

Interrater reliability indicates how well scorescorrelate when a measure is administered by differentinterviewers or when multiple observers rate the samephenomenon [7]. Demonstration of interrater reliabilityis not necessary for self-administered questionnairesbut is necessary for instruments based on observerratings or using multiple interviewers. A correlation of0.80 or higher between raters indicates good interraterreliability [7].

Validity refers to the ability of an instrument to measurewhat it was intended to measure [4, 6, 7]. A measureshould be validated for each specific condition oroutcome for which it will be used. For example ameasure designed to assess stress incontinencewould not be valid for OAB unless it were specificallyvalidated in patients with OAB symptoms.

Content validity, convergent validity, discriminant

validity and criterion validity typically are required tovalidate a questionnaire [7]. Content, or face, validityis a qualitative assessment of whether the question-naire captures the range of the concept it is intendedto measure [6, 7]. For example, does a measure ofsymptom severity capture all the symptoms thatpatients with a particular condition have, and if so, isthe measure capturing the items in a mannermeaningful to patients? To obtain content validity,patients and clinical experts review the measure andjudge whether the questions are clear, unambiguous,and comprehensive [4].

Convergent validity is a quantitative assessment ofwhether the questionnaire measures the theoreticalconstruct it was intended to measure [4, 6]. Convergentvalidity indicates whether a questionnaire has strongerrelationships with similar concepts or variables.Stronger relationships should be seen with the mostclosely related constructs and weaker relationshipsseen with less-related constructs [6]. Discriminantvalidity indicates whether the questionnaire candifferentiate between known patient groups (eg, thosewith mild, moderate, or severe disease) [6];. generally,measures that are highly discriminative are also highlyresponsive.

Criterion validity reflects the correlation betweenthe new questionnaire and an accepted reference,or gold standard [6, 7]. One difficulty in establishingcriterion validity is that a gold-standard measure mightnot be available [6, 7]. When criterion validity can beestablished with an existing measure, the correlationshould be 0.40 to 0.70; correlations approaching 1.0indicate that the new questionnaire may be too similarto the gold-standard measure and therefore redundant[7].

Responsiveness indicates whether the measure candetect change in a patient’s condition [5].An importantaspect of responsiveness is determining not onlywhether the measure detects change but whether thechange is meaningful to the patient. This can be doneby determining the minimal important difference(MID) of the measure. The MID is the smallest changein a PRO questionnaire score that would be consideredmeaningful or important to a patient [6, 8-10]. Atreatment that is statistically significantly better thananother may not necessarily have made a meaningfuldifference to the patient; the MID indicates whetherthe treatment made such a difference from a patientperspective [8-10].

Unfortunately, there is no scientific test for MID as itis an iterative process that involves two methodologiesto determine the MID of a questionnaire: an anchor-based approach and a distribution-based approach [11,12]. With the anchor-based approach, the MID isdetermined by comparing the measure to othermeasures (or “anchors”) that have clinical relevance[12], such as a global measure of well-being or

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perception of treatment benefit [10]. With the distribution-based approach, the MID is determined by the statisticaldistributions of the data [12], using analyses such aseffect size, one-half standard deviation, and standarderror of measurement [10, 13].

5. LINGUISTIC AND CULTURAL VALIDATION

Increasingly, PRO questionnaires are required to beused in a number of different populations and settings,however, questionnaires and their psychometricproperties are not necessarily transferable [13, 14].A measure that is valid and reliable for a particularlanguage and culture may not prove so when used ina different population. Linguistic and cultural adaptationof a questionnaire can occur during the developmentphase before validation, or it can be done after thequestionnaire is validated in the language in which itwas initially developed, with the latter being the morecommon approach. Ensuring the linguistic and culturalvalidity of a questionnaire is especially important formeasures used in multinational clinical trials [14].

The principal steps in adapting a measure for differentlanguages and cultures are as follows:

1. two forward translations of the original instrumentinto the new language;

2. quality-control procedures that may include abackward translation (translating the instrumentback into the original language) (15);

3. adjudication of all translated versions;

4. discussion by an expert panel to ensure clarity ofthe translated questionnaire; and

5. testing the translated instrument in monolingual orbilingual patients to ensure that it measures thesame concepts as the original instrument [4, 7,14, 15].

However, if a backward translation of the measuredoes not produce a semantically equivalent instrument,then the instrument may need to be developed in thetarget language, rather than just translated [15].

After cultural and linguistic validation, PROs shouldalso be psychometrically validated within the targetlanguage. Thus, reliability, validity, and responsivenessneed to be assessed with each language translationto confirm the same measurement properties arepresent in the translated language(s) to ensurepsychometric equivalence. If psychometric equivalenceis not present (e,g, not achieving similar or betterresults in new language translation), the cultural andlinguistic translations need to be re-evaluated andperhaps a new instrument may need to be developed.

The ICIQ questionnaires and many of the otherquestionnaires discussed in this chapter have multiplelinguistically validated versions making them useful forInternational implementation. It is also important to notethat the step after linquistic validation, demonstratingpsychometric equivalence, should also be demons-

trated to ensure that the PRO performs equivalentlyin different languages and cultures.

6. REGULATORY OVERSIGHT

As clinicians and scientists have begun to appreciateand accept PROs as appropriate outcome measures,regulatory authorities have issued guidance documentson current best practices in the development andimplementation of PRO in clinical trial settings [3, 16].For PROs to be acceptable outcome measures forregulatory authorities, documentation of measurementproperties must be present as well as evidence ofinclusion of the patient perspective and understandingof the PRO and a cohesive conceptual frameworkthat stipulates how the PRO is related to theintervention. While PROs within this document mayhave a “recommended” status, they may not meet allof the required regulatory guidelines and may requireadditional validation work either from a qualitative orquantitative perspective. It is strongly suggested thatregulatory authorities be contacted early in the processof selecting a PRO for clinical trials to ensure regulatoryacceptance of the PRO.

7. QUESTIONNAIRE DEVELOPMENT - A CONCLUSION

Patient self-completed questionnaires are the mostsuitable method for assessing the patient’s perspectiveof their lower urinary tract, vaginal and bowelsymptopms [17]. Questionnaires may be long anddetailed for use in research, but need to be short andeasy to use to be relevant for clinical practice. Inaddition to being valid and reliable, they need to beeasy to complete, and, if they are being used tomeasure outcome, sensitive to change. Developinga new questionnaire and testing it thoroughly takesa great deal of time and is only necessary if there isnot an existing instrument available.

There are many questionnaires currently availablefor use and these have been reviewed and describedwith recommendations from the Committee for theiruse in the last three ICI reports.

The major purpose of the ICI has been to provide adefinitive international review and consultative opinionregarding the recommended measures to assesspatient reported outcomes within the area of urinaryincontinence and LUTS. To this end since the FirstConsultation, the ICI has worked to develop a modularformat for the various patient reported outcomesincluding health related quality of life (HRQL) allowingclinicians and researchers to select internationallyrecommended questionnaires for the assessment oftheir patients in both clinical practice and clinical trials.In this the fourth ICI review, the ICIQ modularquestionnaires (supported by the InternationalConsultation) are presented in detail and their useevaluated. Whilst some of the modular questionnairesare still currently under full evaluation their content andformat are presented within this chapter.

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A detailed review of recommended questionnaireswas provided in the First Consultation chapter [18].At the Second Consultation, the Committee developedstandardised grades of recommendation forquestionnaires which attempted to reflect the OxfordCentre for Evidence Based Medicine’s Levels ofEvidence. These were applied to evaluate question-naires concerned with urinary incontinence [19]. Atthe Third Consultation, these grades were revisedand updated to take into account the increasingnumbers of published questionnaires concerned withLUTS and incontinence, and also broadening of thefield to include pelvic organ prolapse (POP) and faecalincontinence (FI) as well as LUTS and urinaryincontinence (UI).

At the Second and Third Consultations, the Committeedevised three grades of recommendation [19] (Table1).

• Questionnaires were ‘highly recommended’ andgiven a Grade A if the Committee found “Publisheddata indicating that the questionnaire is valid,reliable and responsive to change followingstandard psychometric testing. Evidence must bepublished on all three aspects and questionnairesmust be relevant for use with persons withincontinence.”

• Questionnaires were “recommended” and givena Grade B if the Committee found “Published dataindicating that the questionnaire is valid and reliablefollowing standard psychometric testing. Evidencemust be published on two of the three main aspects(usually validity and reliability).”

• Questionnaires were considered to have “potential”and given Grade C if the Committee found“Published data (including abstracts) indicating

that the questionnaire is valid or reliable orresponsive to change following standardpsychometric testing.”

The Committee decided that evidence published inabstracts or posters could be used to indicate adeveloping questionnaire’s potential, but was notsufficiently peer-reviewed to provide the basis for astronger recommendation.

This current Fourth Consultation represents adeparture from the recommendation scheme of the lastreview. In this fourth review questionnaires will still begraded A, B, or C as outlined above. However therecommendation will be to preferably utilisequestionnaires from the ICIQ modules described indetail below. Many, but not all, of these questionnairesare Grade A questionnaires by previously stipulatedcriteria. Within the description of the ICIQ modulesbelow the grade assigned to each module is indicated.

Should none of the modular questionnaires be deemedappropriate for specific research or clinical purposes,ICI’s recommendation is to use a Grade A question-naire as previously recommended and where nosuitable instrument exists a Grade B or C question-naire.

For UI and UI/LUTS, the Committee examined thequality of the psychometric evidence. Only wherepublished data were scientifically sound was the label‘with rigour’ allowed. Where the Committee hadconcerns about the quality of evidence, this is notedin the descriptions of the questionnaires below. TheCommittee considered that the number of high qualityquestionnaires means that there are now sufficientquestionnaires for most purposes and it is notnecessary to encourage the development of newquestionnaires, except for particular patient groups(see below). As for the last Consultation, it is expectedthat by the next Consultation, Grade Anewquestionnaires will either be promoted to Grade Abecause of further high quality publications or relegatedto Grade B if further development does not occur.

The Committee felt that the development ofquestionnaires in the areas of pelvic organ prolapse(POP) and faecal incontinence (FI) was at a muchearlier level. This necessitated a slightly different setof grades of recommendation so that researchers are

GRADES OF RECOMMENDATION FORQUESTIONNAIRES 2008

5B - B. RECOMMENDED PROQUESTIONNAIRES

Table 1. Criteria for recommendation of questionnaires for UI and UI/LUTS at the Fourth Consultation 2008

Grade of recommendation Evidence required (published)

Recommended (Grade A) Validity, reliability and responsiveness established with rigour in several data sets

Recommended (Grade Anew) Validity, reliability and responsiveness indicated with rigour in one data set

(Grade B) Validity, reliability and responsiveness indicated but not with rigour. Validity and reliability established with rigour in several data sets. To be used if suitable questionnaires not available in ICIQ modular format or Grade A or Grade A new

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encouraged to continue to work to producequestionnaires with the highest levels of evidence(see Table 2).

The ICIQ modular questionnaire was developed tomeet the need for a universally applicable standardguide for the selection of questionnaires for use inclinical practice and clinical research [18, 19]. Thedecision to develop standard questionnaire moduleswas taken by the Committee after the first ICI meetingin 1998, and resulted in the development of the ICIQcore questionnaire discussed in this section. It wasrecognised at that time that there were many goodvalidated questionnaires each developed for a specificpurpose and each subtly different. Although developersof the questionnaires were familiar with their contentand use, the increasing number of questionnairesmade appropriate selection difficult and limited theability to compare similar clinical and research datadue to different data collection methods.

An international advisory board was established tocontinue the development of the modular ICIquestionnaire outside the limits imposed by triennialconvening of the ICI Committee. Early discussionswith the advisory board resulted in the decision toexpand the concept to include wider urinary symptoms,bowel symptoms and vaginal symptoms. The advisoryboard consisted of clinicians and researchers withexperience in the design and use of questionnairesrepresenting the major societies involved in theassessment and research of lower genital tract, lower

urinary tract and bowel function. The members of theadvisory board of the ICI can be seen on the ICIQwebsite at www.iciq.net. The ICIQ modular question-naire was then established.

The ICIQ’s objective is to provide internationalconsensus on the use of patient completedquestionnaires for the assessment of lower pelvicsymptoms and their impact on patient’s lives. Threeaims underpin the ICIQ in order to achieve clarityover questionnaire use:

• To recommend high quality self-completionquestionnaires according to evidence of validationas stipulated by the three prior ICI Committees;

• To promote wider use of questionnaires tostandardise assessment of lower urinary tract andpelvic dysfunction and its impact on patients’s lives,in order to;

• Facilitate communication in different patient settingsand different patient groups both in clinical practiceand wider clinical research.

The ICIQ recognised that many high quality publishedquestionnaires already existed and, with permissionfrom the authors, those instruments were adoptedinto the modular project. It was not possible to adoptall available questionnaires and where more than oneoption existed the most appropriate questionnaire forthe purpose was included. Where high qualityquestionnaires were not available, the need to developa new questionnaire/s was acknowledged. Collabo-rative efforts to develop new questionnaires arewelcome and encouraged.

The ICIQ’s international nature requires thatlinguistically validated translations are available. Morethan 50 language versions of various modules havebeen validated to date, conducted according toestablished protocol.

Thirteen ICIQ modules/questionnaires are currentlyavailable for use, with further modules in development(discussed in detail below). Clinicians or researchersare able to select module(s) to meet the particularrequirements of their study or clinical practice. In orderto simplify this selection process, modules have beencategorised as shown in Table 3. It must be stressedthat although multiple questionnaires can and probablyshould be used they must be used in the format inwhich they were originally designed and thequestionnaires cannot be merged together.

In this chapter questionnaires forming part of the ICIQmodular format are referred to as those preferred forusage. Although many of the modules are Grade Aquestionnaires, others are still under various phasesof development and are graded appropriately.

I. AIMS AND OBJECTIVES

5B - C. INTERNATIONALCONSULTATION ON

INCONTINENCE MODULARQUESTIONNAIRE (ICIQ):

WHAT IS THE ICIQ?

Table 2. Criteria for recommedation of questionnairesfor POP and FI at the Fourth Consultation 2008

Grade of recommendation Evidence required (published)

Recommended (Grade A) Validity, reliability and responsiveness established with rigour.

(Grade B) Validity and reliability established with rigour, or validity, reliability andresponsiveness indicated.

With potential (Grade C) Early development – further work required and encouraged

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Questionnaires that are in early stages of developmentand have yet to reach Grade C are described as “indevelopment”. Where an ICIQ module is not availableit is recommended that a Grade A or B or C question-naire is used.

1. CORE MODULES

Questionnaires to assess the core symptoms of lowerpelvic dysfunction:

• Lower urinary tract symptoms (male and femalespecific versions).

• Urinary incontinence (male and female applicableversion).

• Vaginal symptoms (female version only).

• Bowel symptoms including incontinence (male andfemale applicable version).

Each module is intended for the comprehensive yetsuccinct measurement of symptoms and associated‘bother’. The bother item attached to each symptomenables the individual to indicate areas that causethe greatest negative impact on HRQL as perceivedby them. This can be a more sensitive indicator oftreatment goals than frequency of symptoms alone.

2. SPECIFIC PATIENT GROUPS

Questionnaires to assess specific conditions orsymptom complexes such as nocturia and overactivebladder are contained in this section. This categoryalso includes specific patient groups, for example,children. These instruments contain only questionitems characteristic of the symptom complex or havebeen developed specifically for use in a diverse groupmaking the items/questionnaire only utilisable in thatpopulation.

• Nocturia (male and female applicable version).

• Overactive bladder (male and female applicableversion).

• Patients with spinal cord disease.

• Patients using long term catheters.

• Lower urinary tract symptoms in children.

Bother items are again included for all except thechildren’s questionnaire.

1. CORE MODULES

These questionnaires incorporate modules for

assessment of health-related quality of life (HRQL) andsexual matters and are recommended to be completedalongside symptom evaluations. The core symptommodules described above contain bother itemsindicating impact on quality of life directly related tosymptoms. The HRQL questionnaires recommendedhere cover specific issues that are a consequence ofsymptoms, such as limitations on activities and impacton relationships.

• HRQL associated with lower urinary tract symptoms(male and female applicable version).

• HRQL associated with vaginal symptoms (femaleversion only).

• HRQL associated with bowel symptoms (male andfemale applicable version).

• Sexual matters associated with lower urinary tractsymptoms (male and female specific versions).

• Sexual matters associated with vaginal symptomsare included in the symptom questionnaire as theissues were considered too intrinsically linked toseparate for evaluation.

Bother sub-items are again included to provide moredetailed information about impact on quality of lifethan frequency of impact alone. The assessment ofsymptoms in combination with quality of life enablesa more thorough and detailed evaluation of thepatient’s experience [20,21]. Given the nature of lowerpelvic dysfunction, sexual matters can also be affectedand questionnaires are available to evaluate thiswhere appropriate.

2. SPECIFIC PATIENT GROUPS

In the same manner as the symptom modules, HRQLmodules are available for specific symptom complexes:

• HRQL associated with nocturia (male and femaleapplicable version).

• HRQL associated with overactive bladder (male andfemale applicable version).

This category includes lengthier questionnaires formore exploratory evaluation of the core symptoms oflower pelvic dysfunction. Whilst these questionnairesare suitable for use in clinical practice, they have notbeen shortened for clinical efficiency and are thereforemore widely used in research studies where explora-tion of broader associated symptoms may be desired.

• Lower urinary tract symptoms (male and femalespecific versions).

• Urinary incontinence (male and female applicableversion).

IV. OPTIONAL MODULES

III. ICIQ HEALTH-RELATED QUALITYOF LIFE AND SEXUAL FUNCTION

MODULES

II. ICIQ SYMPTOM AND BOTHERMODULES

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The ICIQ module for post-treatment satisfaction is inthe early stages of development. Assessment of apatient’s satisfaction with treatment (behavioural,surgical or medication) provides information ontreatment impact on their condition and life andincludes their perception of effectiveness, tolerabilityand convenience. It is not yet clear if satisfactionfollowing treatment can be characterised by a set ofcommon question items that are applicable to alldisorders of the lower urinary tract and pelvic floor. Aswith HRQL, there are generic and disease specificquestionnaires that assess satisfaction. Ongoingstudies will provide further evidence on which to makesuggestions regarding post treatment evaluation butit is likely that this will encompass both generic andcondition specific measures. Ultimately, the develop-ment of post treatment modules will also rely on advicefrom regulatory authorities (eg FDA) to ensure thatmeasures capture a recognised multidimensionalityof satisfaction.

The ICIQ recommends the use of a ‘core’, ‘symptom-specific’,or ‘add-on’ modules that match the intendedpurpose of a study. Whilst this may necessitate the useof a module from each section, there is no requirementto do so. The characteristics of each module is summa-rised below, although more extensive information canbe found on the project website, www.iciq.net.

Tables 4, 5 a,b,c

The ICIQ modular questionnaire has attractedconsiderable attention from both clinicians andresearchers worldwide since its structure was finalisedin 2004. More than 500 requests for use of the variousmodules have been documented and over 40published studies were identified up to April 2008,with the majority originating from Europe, particularlythe UK.

The most widely applied module is the ICIQ-UI ShortForm, particularly to evaluate female urinary

incontinence, though a handful of studies evaluatingseverity of incontinence in men resulting fromprostatectomy for cancer or treatment for bladderoutlet obstruction related to benign prostatic enlar-gement have been reported [31, 32]. Most studiesrelate to epidemiological research, including preva-lence surveys of urinary incontinence or lower urinarytract symptoms [33, 34]; and outcomes research,including prospective and randomised clinical trials oftreatments including surgery [35], drug therapies [36]and conservative treatments [37]. For example, arecent placebo-controlled randomised trial found thatduloxetine significantly reduced ICIQ scores in womenwith mixed urinary incontinence[36].

Reports on further validation and translations of theICIQ and related educational projects have also beenpublished. A recent study conducted by Franco, Leeand Fynes [38], for example, compared variousvalidated subjective measures of urinary incontinenceseverity to the one hour pad test in women andreported that only the ICIQ correlated significantlywith this clinical variable, thereby recommending itsuse in routine clinical practice as an alternative to padtests. Encouraging relationships between the ICIQand other urodynamic parameters have also beenreported [39].

The ICIQ has also been applied to hospital and generalpractice settings, and has been adopted in nationalguidelines for the management of urinary incontinencein primary care by the Scottish IntercollegiateGuidelines Network (www.sign.ac.uk/pdf/sign79.pdf)and in a primary care resource pack by the BritishSociety of Urogynaecology.

The ICIQ modular questionnaire project (www.iciq.net)provides a series of standardised questionnaires forthe patient reported assessment of lower pelvicdysfunction symptoms and their impact on patientslives. The ICIQ provides clarity over the selection ofquestionnaires by recommending only those withevidence of high quality and robust psychometricvalidation including validity, reliability and sensitivityto change. This assurance provides the user withconfidence in the results obtained, which is importantin clinical practice and research where treatmentdecisions or trial outcomes depend on this evidence.Increasing awareness of the ICIQ aims to promoteincreased use of standardised questionnaires, therebyfacilitating communication between clinicians andresearchers and enable more widespread compa-risons between different treatments and patient groupsworldwide.

IX. CONCLUSION

VIII. ICIQ QUESTIONNAIREIMPLEMENTATION

VII. ICIQ MODULES

VI. GUIDANCE FOR USE OF THE ICIQ

V. POST-TREATMENT MODULE

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wer

uri

nar

y tr

act

sym

pto

ms

and

asso

ciat

edbo

ther

.

Ava

ilabl

e fo

r us

e.P

ublis

hed

evid

ence

of v

alid

ity,

relia

bilit

y an

d re

spon

sive

ness

[22,

23].

Var

ied

low

er u

rinar

y tr

act

sym

ptom

s.18

7

ICIQ

-FLU

TS

sex

(BF

LUT

S[2

3])

Gra

de A

Ass

essm

ent o

f fe

mal

e se

xual

mat

ters

asso

ciat

ed w

ith u

rin

ary

sym

pto

ms

and

rela

ted

both

er.

Ava

ilabl

e fo

r us

e.P

ublis

hed

evid

ence

of v

alid

ity,

relia

bilit

y an

d re

spon

sive

ness

[23]

.

Pai

n an

d le

akag

e w

ith s

exua

lin

terc

ours

e.O

vera

ll in

terf

eren

ce.

418

ICIQ

-LU

TS

qol

(Kin

g’s

Hea

lthQ

uest

ionn

aire

[24]

) G

rad

e A

Det

aile

d as

sess

men

t of H

RQ

L is

sues

asso

ciat

ed w

ith u

rin

ary

sym

pto

ms

and

rela

ted

both

er in

bot

h m

en a

nd w

omen

.

Ava

ilabl

e fo

r us

e.P

ublis

hed

evid

ence

of v

alid

ity,

relia

bilit

y an

d re

spon

sive

ness

[24]

.

Life

res

tric

tions

.E

mot

iona

l asp

ects

.P

reve

ntiv

e m

easu

res.

2245

ICIQ

-MLU

TS

(IC

Sm

aleS

F[2

5])

Gra

de

A

Com

preh

ensi

ve a

sses

smen

t of

mal

e lo

wer

uri

nar

y tr

act

sym

pto

ms

and

asso

ciat

edbo

ther

.

Ava

ilabl

e fo

r us

e.P

ublis

hed

evid

ence

of v

alid

ity,

relia

bilit

y an

d re

spon

sive

ness

.

Voi

ding

.In

cont

inen

ce.

Indi

vidu

al it

ems

eval

uatin

gfr

eque

ncy

and

noct

uria

.

1326

ICIQ

-MLU

TS

Long

For

m(I

CS

mal

e[2

6,27

])G

rad

e A

Det

aile

d as

sess

men

t of m

ale

low

er u

rin

ary

trac

t sy

mp

tom

s an

d as

soci

ated

bot

her.

Ava

ilabl

e fo

r us

e.P

ublis

hed

evid

ence

of v

alid

ity,

relia

bilit

y an

d re

spon

sive

ness

[26,

27].

Var

ied

low

er u

rinar

y tr

act

sym

ptom

s.23

29

ICIQ

-MLU

TS

sex

(IC

Sm

ale[

27])

Gra

de

A

Ass

essm

ent o

f m

ale

sexu

al m

atte

rsas

soci

ated

with

uri

nar

y sy

mp

tom

s an

dre

late

d bo

ther

.

Ava

ilabl

e fo

r us

e.P

ublis

hed

evid

ence

of v

alid

ity,

relia

bilit

y an

d re

spon

sive

ness

[26,

27].

Ere

ctio

n an

d ej

acul

atio

nis

sues

.O

vera

ll in

terf

eren

ce.

424

ICIQ

-Nqo

l(N

-QoL

[28]

)G

rad

e A

Det

aile

d as

sess

men

t of H

RQ

L is

sues

asso

ciat

ed w

ith n

oct

uri

a.

Ava

ilabl

e fo

r us

e.P

ublis

hed

evid

ence

of v

alid

ity,

relia

bilit

y an

d re

spon

sive

ness

[28]

.

Issu

es a

ssoc

iate

d w

ith s

leep

dist

urba

nce.

Life

res

tric

tions

.P

reve

ntiv

e m

easu

res.

1327

Tab

le 4

. IC

IQ M

od

ule

Des

crip

tio

n

374

Nam

e/G

rad

eP

urp

ose

Ava

ilab

ility

Do

mai

ns

Item

sA

vaila

ble

Tra

nsl

atio

ns

ICIQ

-N(I

CS

mal

eSF

/B

FLU

TS

-SF

[22,

25])

Gra

de

B

Com

preh

ensi

ve a

sses

smen

t of s

ympt

oms

ofn

oct

uri

a a

nd a

ssoc

iate

d bo

ther

.A

vaila

ble

for

use.

Evi

denc

e of

val

idity

, rel

iabi

lity

and

resp

onsi

vene

ss [2

2,25

,27]

.

Fre

quen

cy.

Noc

turia

.

230

ICIQ

-OA

B(I

CS

mal

eSF

/B

FLU

TS

-SF

[22,

25])

Gra

de

A

Com

preh

ensi

ve a

sses

smen

t of s

ympt

oms

ofo

vera

ctiv

e b

lad

der

and

ass

ocia

ted

both

er.

Ava

ilabl

e fo

r us

e.

Evi

denc

e of

val

idity

, rel

iabi

lity

and

resp

onsi

vene

ss [2

2,25

,27]

.R

esp

on

sive

nes

s n

ot

dem

on

stra

ted

in O

AB

pat

ien

ts

Fre

quen

cy.

Noc

turia

.

Urg

ency

.

Urg

ency

inco

ntin

ence

.

422

ICIQ

-OA

Bqo

l(O

AB

-q [

29])

Gra

de

A

Det

aile

d as

sess

men

t of h

ealt

h-r

elat

edq

ual

ity

of

life

issu

es a

ssoc

iate

d w

itho

vera

ctiv

e b

lad

der

.

Ava

ilabl

e fo

r us

e.

Pub

lishe

d ev

iden

ce o

f val

idity

,re

liabi

lity

and

resp

onsi

vene

ss [2

9].

Cop

ing,

Con

cern

/Wor

ry

Sle

ep

Soc

ial I

nter

actio

n

2550

+

ICIQ

-UI S

hort

For

m [1

8] (

ICIQ

)G

rad

e A

Com

preh

ensi

ve a

sses

smen

t of m

ale/

fem

ale

uri

nar

y in

con

tin

ence

.A

vaila

ble

for

use.

Pub

lishe

d ev

iden

ce o

f val

idity

,re

liabi

lity

and

sens

itivi

ty to

cha

nge1 .

Urin

ary

inco

ntin

ence

incl

udin

gite

ms

on fr

eque

ncy

and

amou

nt o

f lea

kage

and

ove

rall

inte

rfer

ence

.

A s

elf-

diag

nost

ic it

em in

vite

sre

spon

dent

s to

indi

cate

the

perc

eive

d ca

use

ofin

cont

inen

ce.

432

ICIQ

-VS

[30]

Gra

de

A

Com

preh

ensi

ve a

sses

smen

t of v

agin

alsy

mp

tom

s an

d as

soci

ated

bot

her.

Ava

ilabl

e fo

r us

e.

Pub

lishe

d ev

iden

ce o

f val

idity

,re

liabi

lity

and

resp

onsi

vene

ss [3

0].

Vag

inal

sym

ptom

s.

Sex

ual m

atte

rs.

Qua

lity

of li

fe.

142

Tab

le 4

. IC

IQ M

od

ule

Des

crip

tio

n (

con

tin

ued

)

375

Nam

e / G

rad

eP

urp

ose

Cu

rren

t S

tatu

sD

evel

op

men

t M

eth

od

olg

yD

om

ain

sIt

ems

ICIQ

-B

Gra

de C

Com

preh

ensi

veas

sess

men

t of

mal

e/fe

mal

e b

ow

elsy

mp

tom

s, , p

redo

min

antly

inco

ntin

ence

, and

asso

ciat

ed b

othe

r.

New

ly d

evel

oped

; tes

ting

com

plet

ed;

awai

ting

publ

icat

ion

Item

s ge

nera

ted

by c

linic

al e

xper

ts a

nd p

atie

nts

with

ana

l inc

ontin

ence

[12]

.

Ext

ensi

ve c

onte

nt v

alid

ity te

stin

g w

ith p

oten

tial

resp

onde

nts

and

clin

ical

exp

erts

. Psy

chom

etric

test

ing

perf

orm

ed; a

wai

ting

publ

icat

ion

Bow

el p

atte

rn.

Bow

el c

ontr

ol.

Qua

lity

of li

fe.

21

ICIQ

-CLU

TS

Gra

de C

Ass

essm

ent o

f urin

ary

sym

ptom

s in

ch

ildre

n.

Crit

erio

n va

lidity

test

ing

is c

urre

ntly

ongo

ing

in th

e U

K, I

taly

and

Ger

man

y by

way

of c

ompa

rison

sw

ith c

linic

al fl

ow te

sts

to e

valu

ate

the

abili

ty o

f the

que

stio

nnai

re to

ref

lect

clin

ical

find

ings

.

The

dra

ft in

stru

men

t has

bee

n pr

epar

ed th

roug

hqu

alita

tive

inte

rvie

ws

with

chi

ldre

n an

d th

eir

pare

nts/

care

give

rs in

com

bina

tion

with

clin

ical

expe

rts

in th

e fie

ld to

est

ablis

h th

e cl

inic

al a

reas

of im

port

ance

and

the

pert

inen

t iss

ues

for

thos

ew

ith th

e sy

mpt

oms.

Dom

ains

to b

e de

term

ined

;

Que

stio

ns o

n ur

inar

y sy

mpt

om,

bedw

ettin

g an

d in

cont

inen

ce

ICIQ

-LT

C

Gra

de C

Ass

essm

ent o

f urin

ary

sym

ptom

s an

d im

pact

on

qual

ity o

f life

ass

ocia

ted

with

lon

g t

erm

cath

eter

isat

ion

and

rela

ted

both

er.

Con

tent

val

idity

test

ing

and

full

psyc

hom

etric

val

idat

ion

are

unde

rway

.

Thi

s dr

aft q

uest

ionn

aire

has

bee

n pr

epar

ed in

colla

bora

tion

with

clin

ical

exp

erts

in th

is a

rea

and

patie

nts

who

man

age

thei

r ur

inar

y sy

mpt

oms

thro

ugh

long

term

cat

hete

risat

ion.

Dom

ains

to b

e de

term

ined

;Q

uest

ions

to b

e as

sess

ed:

leak

age,

blo

ckag

e, b

ladd

er s

tone

s,in

fect

ions

;cop

ing

stra

tegi

es; s

ocia

lfu

nctio

ning

; at

titud

es; a

nd b

ody

imag

e.

Tab

le 5

a. I

CIQ

Des

crip

tio

n o

f M

od

ule

s in

Dev

elo

pm

ent

376

Tab

le 5

b.

ICIQ

Des

crip

tio

n o

f M

od

ule

s in

Dev

elo

pm

ent

Nam

e/G

rad

eP

urp

ose

Cu

rren

t S

tatu

sD

evel

op

men

t M

eth

od

olg

yD

om

ain

sIt

ems

ICIQ

-Spi

nal c

ord

dise

ase

Inde

velo

pmen

t

Ass

essm

ent o

f urin

ary

sym

ptom

s an

d im

pact

on q

ualit

y of

life

asso

ciat

ed w

ithsp

ecif

ic m

anag

emen

td

evic

es a

nd r

elat

edbo

ther

.

Con

tent

val

idity

test

ing

and

full

psyc

hom

etric

val

idat

ion

are

due

toco

mm

ence

.

Thi

s dr

aft q

uest

ionn

aire

has

bee

npr

epar

ed in

col

labo

ratio

n w

ithcl

inic

al e

xper

ts in

this

are

a an

dpa

tient

s w

ho m

anag

e th

eir

urin

ary

sym

ptom

s w

ith v

aryi

ng d

evic

es.

Pat

ient

s w

ith s

pina

l cor

d di

seas

eof

var

ying

cau

ses

part

icip

ated

inqu

alita

tive

inte

rvie

ws

to e

xplo

reth

e ef

fect

s an

d im

pact

on

qual

ityof

life

ass

ocia

ted

with

the

devi

ces

used

to m

anag

e th

eir

blad

der

sym

ptom

s.

lQu

estio

n s

rega

rdin

g th

efo

llow

ing

will

be

ask e

d: B

ladd

eran

d b

owel

func

tion,

iss u

es a

s soc

iate

d w

ith s

pec i

ficm

an ag

emen

t dev

ices

, s ex

ual

mat

ters

, and

life

styl

ein

terfe

re nc

e.

ICIQ

-UI L

ong

For

mD

etai

led

asse

ssm

ent o

fp

erce

ived

cau

ses

of

uri

nar

y in

con

tin

ence

.

Con

tent

v al

idity

test

ing

ha s

been

com

plet

edpr

e pa

ring

the

d ev

elop

men

tal I

CIQ

-UI L

on g

For

m fo

r fu

ll p

sych

om et

ric v

alid

a tio

n.In

terv

iew

s w

ith p

oten

tial r

espo

nd en

ts h

ave

con

firm

ed th

at th

e qu

estio

n na

ire is

app

licab

le a

nd a

ppro

p ria

te fo

r a d

etai

led

ass e

ssm

en t o

f u rin

ary

inco

n tin

enc e

sym

ptom

s. V

alid

atio

n is

und

erw

ay.

Thi

s dr

aft q

uest

ionn

aire

has

bee

npr

epar

ed in

col

labo

ratio

n w

ithcl

inic

al e

xper

ts in

this

are

a an

dpa

tient

s w

ith s

ympt

oms

of u

rinar

yin

cont

inen

ce. P

atie

nts

with

urin

ary

inco

ntin

ence

par

ticip

ated

inqu

alita

tive

inte

rvie

ws

to e

xplo

reth

e ca

use

of th

eir

sym

ptom

s an

dth

e is

sues

of i

mpo

rtan

ce r

elat

edto

this

.

For

eac

h pe

rcei

ved

caus

e of

inco

ntin

ence

, e.g

. phy

sica

lac

tivity

, urg

ency

rel

ated

,no

ctur

nal l

eaka

ge, t

he d

egre

eof

bot

her

and

amou

nt o

fle

akag

e ar

e ev

alua

ted.

Tab

le 5

c: I

CIQ

Des

crip

tio

n o

f M

od

ule

s in

Dev

elo

pm

ent

Nam

e/G

rad

eP

urp

ose

Cu

rren

t S

tatu

sD

evel

op

men

t M

eth

od

olg

yD

om

ain

sIt

ems

ICIQ

-VS

qol (

Inde

velo

pmen

t)D

etai

led

asse

ssm

ent o

fH

RQ

L is

sues

asso

ciat

ed w

ith v

agin

alsy

mp

tom

s an

d re

late

dbo

ther

.

Con

tent

val

idity

test

ing

has

been

com

plet

ed p

repa

ring

the

deve

lopm

enta

l IC

IQ-V

Sqo

l.In

terv

iew

s w

ith p

oten

tial

resp

onde

nts

have

con

firm

ed th

atth

e qu

estio

nnai

re is

app

licab

lean

d ap

prop

riate

for

asse

ssm

ent

of th

e ef

fect

s of

vag

inal

sym

ptom

s, c

aptu

ring

all a

spec

tsof

rel

evan

ce. P

syho

met

ricva

lidat

ion

is u

nder

way

.

Thi

s dr

aft q

uest

ionn

aire

has

bee

n pr

epar

edin

col

labo

ratio

n w

ith c

linic

al e

xper

ts in

this

area

and

wom

en w

ith v

agin

al s

ympt

oms.

Pat

ient

s w

ith v

agin

al s

ympt

oms

of v

aryi

ngca

use

part

icip

ated

in q

ualit

ativ

e in

terv

iew

sto

exp

lore

the

effe

cts

and

impa

ct o

n qu

ality

of li

fe a

ssoc

iate

d w

ith th

eir

sym

ptom

s.

Dom

ains

to b

e de

term

ined

.Q

uest

ions

reg

ardi

ng th

efo

llow

ing

will

be

aske

d: l

ifere

stric

tions

and

em

otio

nal

aspe

cts.

377

There are a variety of PRO measures available for usein clinical practice and research that assess a rangeof concepts (e.g. HRQL, patient satisfaction, symptombother, etc). This section and table series provides anoverview and assessment of those measures.Importantly, clinical practitioners and researchersneed to clearly determine their clinical and researchobjectives before selecting a PRO as it is theseobjectives and the target patient population that willhelp determine which validated PRO is appropriate touse. Tables 6 to 10 provide a brief overview of allcurrent PRO measures for urinary incontinence andLUTS, their purpose, psychometric properties,translation availability, and recommended ICI grade.

Certainly an area which has rapidly grown with PROmeasures is that of urinary incontinence and LUTS andHRQL assessments (Table 6). The literaturesupporting HRQL assessments was reviewed and aGrade A to C recommendation assigned. Please note,as instrument development and validation is anongoing process, the tables below contain publicationsprior to July 2008. As additional work may have beenperformed on an instrument, it is always prudent toconduct a further literature search and/or contact theinstrument developer prior to selecting an outcomemeasure for your clinical practice or study.

One trend that has become more apparent since theprevious Consultations is the modification of moreestablished urinary incontinence questionnaires for usein selected patient groups (e.g., pelvic organ prolapse;males; different cultural/language groups). When usinga questionnaire in a patient group other than the groupin which it was initially developed, cognitive debriefingswith the new patient population should be held toreview the applicability of the questionnaire to thenew patient group. Several of the main questionnairesto be discussed below have now had modified versionspublished in the literature. The Committee’s view isthat although it may be appropriate to modifyestablished questionnaires for use with somepopulations, it is advisable to keep such modificationsto a minimum, and to use the original versionswhenever possible. Any modifications of establishedquestionnaires may result in changes (sometimessubstantial) in the psychometric performance of theinstrument, and thus all modified instruments shouldbe subjected to the same psychometric testing as

that employed in developing a completely newinstrument. Specifically, modified instruments shouldreport information regarding the instrument’s constructvalidity, reliability, and test-retest reliability, at aminimum, and sensitivity to change, in interventionstudies.

For some of the more widely used instruments listedbelow, several modified, shortened versions havebeen published. Information regarding the modifiedversions is provided under the original source versionsof the questionnaires, but the modified versions areevaluated and graded separately, based on theavailable information regarding their psychometricproperties and performance.

1. BFLUTS AND BFLUTS-SF

The long form of BFLUTS [23, 26] was developed foruse with women, following the pattern established forthe questionnaire developed for the ICS-’BPH’ study.The questionnaire covers the occurrence andbothersomeness of symptoms relating to incontinenceand other lower urinary tract symptoms [23, 26]. Ithas shown good levels of validity and reliability andhas been increasingly used in epidemiological andoutcome studies [40-45]. Validity, reliability andresponsiveness have been demonstrated, and ascored short form has been produced, which is nowthe recommended version [22].

2. DAN-PSS

This questionnaire was designed in Denmark tomeasure the degree to which men are bothered byurinary symptoms [46, 47]. A composite score isachieved by the multiplication of the ‘symptom’ by the‘bother’ score, with a total range of 0 to 108 [46, 47].A computer version of this questionnaire has beenvalidated and patients seemed to appreciated morethis new version than the paper version [48]. It isprimarily a questionnaire for the assessment of theoccurrence and bothersomeness of a wide range ofLUTS in men.

3. ICSMALE AND ICSMALE SF

The ICSmale questionnaire contains 22 questions on20 urinary symptoms, and, for most questions, thedegree of problem that the symptom causes [26]. Ithas exhibited acceptable levels of validity, reliabilityand sensitivity to change following a range oftreatments including surgery, minimally invasivetherapies and drug treatments [26, 27, 49]. This longversion has been largely replaced now by a scoredshort-form – ICSmaleSF [25]. A modified form ofICSmale has been used to assess LUTS andincontinence in prostate cancer [50]. It also continues

I. HEALTH-RELATED QUALITY OFLIFE MEASURES

5B - D. PATIENT REPORTEDOUTCOME (PRO)

QUESTIONNAIRES TO ASSESSTHE IMPACT OF URINARYINCONTINENCE, OAB ANDLOWER URINARY TRACT

SYMPTOMS

378

Tab

le 6

. S

um

mar

y o

f U

rin

ary

Inco

nti

nen

ce,

OA

B a

nd

LU

TS

PR

O M

easu

res

– H

RQ

L

Rel

iab

ility

Val

idit

y

PR

O N

ame

/ Gra

de

Pu

rpo

se o

f T

oo

lP

op

ula

tio

nS

amp

le

Inte

rnal

Co

nsi

-st

ency

Tes

t-re

test

Co

n-

ten

tC

rite

-ri

on

Co

n-

curr

ent

Dis

cr-

imin

ant

Res

po

nsi

ve-n

ess

(Tre

atm

ent

Du

rati

on

)

Psy

cho

met

ric

Val

idat

ion

inO

ther

Lan

gu

ages

Ava

ilab

le L

ang

uag

esB

FL

UT

S (B

risto

lF

emal

e Lo

wer

Urin

ary

Tra

ctS

ympt

oms

Que

stio

nnai

re).

Cur

rent

ly th

e IC

IQ-

FLU

TS

(IC

IQ-F

emal

eLo

wer

Urin

ary

Tra

ctS

ympt

oms)

[23]

Gra

de

A

To

asse

ss fe

mal

eLU

TS

, par

ticul

arly

urin

ary

inco

ntin

ence

,m

easu

re im

pact

on

qual

ity o

f life

and

eval

uate

trea

tmen

tou

tcom

eW

omen

,in

cont

inen

ce√

√√

√B

FLU

TS

Tra

nsla

ted

in 1

0 La

ngua

ges.

http

://w

ww

.iciq

.net

/ICIQ

.FLU

TS

.htm

l

Co

nti

life®

(Q

ualit

y of

Life

Ass

essm

ent

Que

stio

nnai

reC

once

rnin

g U

rinar

yIn

cont

inen

ce)[

102]

Gra

de

B

To

asse

ss th

e im

pact

of u

rinar

yin

cont

inen

ce o

nqu

ality

of l

ife.

Orig

inal

ly d

evel

oped

in F

renc

h an

dde

sign

ed fo

r w

omen

with

UI

(urg

e, s

tres

san

d m

ixed

UI)

Wom

en, S

UI

√√

√√

Con

tilife

Tra

nsla

ted

in 1

1 La

ngua

ges.

http

://pr

oqol

id.o

rg/in

stru

men

ts/q

ualit

y_of

_life

_ass

essm

ent_

ques

tionn

aire

_con

cern

ing_

urin

ary_

inco

ntin

ence

_con

tilife

_rD

AN

-PS

S-1

(D

anis

hP

rost

atic

Sym

ptom

Sco

re)[

46]

Gra

de

A

To

eval

uate

mal

esw

ith L

UT

S s

ugge

stiv

eof

unc

ompl

icat

edB

PH

Men

, BP

H√

√√

√

DA

N-P

SS

-1 tr

ansl

ated

in 9

lang

uage

sht

tp://

proq

olid

.org

/inst

rum

ents

/dan

ish_

pros

tatic

_sym

ptom

_sco

re_d

an_p

ss_1

EP

IQ (

Epi

dem

iolo

gyof

Pro

laps

e an

dIn

cont

inen

ceQ

uest

ionn

aire

)[10

3]G

rad

e B

Dev

elop

ed a

ndva

lidat

ed in

Eng

lish

and

Spa

nish

toas

sess

the

pres

ence

or a

bsen

ce o

f AI,

OA

B, S

UI,

and

pelv

icor

gan

prol

apse

infe

mal

e po

pula

tion

Wom

en,

PF

D√

√√

√√

√T

rans

late

d in

Eng

lish

and

Spa

nish

IBS

(In

cont

inen

ceB

othe

rsom

eS

cale

)[10

4]G

rad

e C

One

item

ques

tionn

aire

toas

sess

the

qual

ity o

flif

e in

wom

en w

ithur

inar

y in

cont

inen

ce.

Wom

en,U

IN

one

Fou

ndIC

IQ-U

I Sh

ort

Fo

rm(I

nter

natio

nal

Con

sulta

tion

onIn

cont

inen

ceQ

uest

ionn

aire

-U

rinar

y In

cont

inen

ceS

hort

For

m (

ICIQ

-UI

Sho

rt F

orm

)[18

,25]

Gra

de

A

To

asse

ss th

esy

mpt

oms

and

impa

ctof

urin

ary

inco

ntin

ence

incl

inic

al p

ract

ice

and

rese

arch

Men

and

Wom

en,

Urin

ary

Sym

ptom

s√

√√

√√

(8 w

eeks

)√

ICIQ

-UI S

F T

rans

late

d in

38

Lang

uage

sht

tp://

proq

olid

.org

/inst

rum

ents

/inte

rnat

iona

l_co

nsul

tatio

n_on

_inc

ontin

ence

_que

stio

nnai

re_u

rinar

y_in

cont

inen

ce_s

hort

_fo

rm_i

ciq_

ui_s

hort

_for

m

379

Tab

le 6

. S

um

mar

y o

f U

rin

ary

Inco

nti

nen

ce,O

AB

an

d L

UT

S P

RO

Mea

sure

s –

HR

QL

(co

nti

nu

ed)

Rel

iab

ility

Val

idit

y

RO

Nam

e / G

rad

eP

urp

ose

of

To

ol

Po

pu

lati

on

Sam

ple

Inte

rnal

Co

nsi

-st

ency

Tes

t-re

test

Co

n-

ten

tC

rite

-ri

on

Co

n-

curr

ent

Dis

cr-

imin

ant

Res

po

nsi

ve-n

ess

(Tre

atm

ent

Du

rati

on

)

Psy

cho

-m

etri

cV

alid

atio

nin

Oth

erL

ang

uag

esA

vaila

ble

Lan

gu

ages

ICS

mal

e (I

CIQ

-M

LUT

S)

(Int

erna

tiona

lC

ontin

ence

Soc

iety

-M

ale)

[18,

25,2

6]G

rad

e A

To

prov

ide

a th

orou

ghev

alua

tion

of th

eoc

curr

ence

and

both

erso

men

ess

oflo

wer

urin

ary

trac

tsy

mpt

oms

and

thei

rim

pact

on

the

lives

of

men

with

ben

ign

pros

tatic

dis

ease

Men

with

LUT

S a

ndpo

ssib

leB

PH

√√

√√

√

icsm

ale

Tra

nsla

ted

in 1

1La

ngua

ges.

http

://pr

oqol

id.o

rg/in

stru

men

ts/

icsm

ale_

icsm

ale

ICS

Qo

L(I

nter

natio

nal

Con

tinen

ce S

ocie

ty-

Ben

ign

Pro

stat

icH

yper

plas

ia s

tudy

qual

ity-o

f-lif

e)[1

05]

Gra

de

A

To

asse

ss im

pact

of

low

er u

rinar

y tr

act

sym

ptom

s on

the

lives

of m

en w

ithLU

TS

Men

with

LUT

S a

ndpo

ssib

leB

PH

√√

√√

√

ICS

QoL

Tra

nsla

ted

in 1

1La

ngua

ges

http

://pr

oqol

id.

org/

inst

rum

ents

/inte

rnat

iona

l_co

ntin

ence

_soc

iety

_ben

ign_

pros

tatic

_hyp

erpl

asia

_stu

dy_

qual

ity_o

f_lif

e_ic

sqol

__1

IIQ (

Inco

ntin

ence

Impa

ctQ

uest

ionn

aire

)[64

]G

rad

e A

Dev

elop

ed to

desc

ribe

the

seve

rity

of in

cont

inen

ce in

apo

pula

tionU

sed

toas

sess

the

impa

ct o

fur

inar

y in

cont

inen

ceon

HR

QL.

Prim

arily

been

eva

luat

ed in

patie

nts

with

str

ess

inco

ntin

ence

.W

omen

, UI,

SU

I√

√√

√ (1

2W

eeks

)√

Ava

ilabl

e in

Eng

lish

and

Tur

kish

IIQ-7

( In

cont

inen

ceIm

pact

Que

stio

nnai

re-

shor

t for

m)[

101]

Gra

de

A

Use

d to

ass

ess

the

impa

ct o

f urin

ary

inco

ntin

ence

on

HR

QL

*val

idat

ion

stud

y on

men

afte

rra

dica

lpr

osta

tect

om

y w

ho h

adU

I√

√√

√A

vaila

ble

in E

nglis

h an

dT

urki

sh

IOQ

(In

cont

inen

ceO

utco

me

Que

stio

nnai

re)[

106]

Gra

de

C

Dev

elop

ed fo

ras

sess

ing

HR

QL

afte

rsu

rger

y fo

r st

ress

urin

ary

inco

ntin

ence

Wom

en S

UI

√√

√N

one

Fou

ndI-

QO

L (I

CIQ

-Uiq

ol)

(Urin

ary

Inco

ntin

ence

-S

peci

fic Q

ualit

y of

Life

Inst

rum

ent)

[75,

107]

Gra

de

A

To

asse

ss q

ualit

y of

life

of w

omen

with

urin

ary

inco

ntin

ence

Men

, UI

√√

√

I-Q

OL

Tra

nsla

ted

in 3

5La

ngua

ges

http

://pr

oqol

id.

org/

inst

rum

ents

/urin

ary_

inco

ntin

ence

_spe

cific

_qua

lity_

of_

life_

inst

rum

ent_

i_qo

l

380

Tab

le 6

. S

um

mar

y o

f U

rin

ary

Inco

nti

nen

ce,

OA

B a

nd

LU

TS

PR

O M

easu

res

– H

RQ

L(c

on

tin

ued

)

35

PR

O N

ame

/ Gra

de

Pu

rpo

se o

f T

oo

lS

amp

lest

ency

rete

stte

nt

rio

ncu

rren

tim

inan

tD

ura

tio

n)

Lan

gu

ages

Ava

ilab

le L

ang

uag

es

KH

Q (

ICIQ

-LU

TS

qol)

(Kin

g’s

Hea

lthQ

uest

ionn

aire

)[2

4,10

8]G

rad

e A

To

asse

ss th

e im

pact

of lo

wer

urin

ary

trac

tsy

mpt

oms

incl

udin

gur

inar

y in

cont

inen

ceon

hea

lth r

elat

edqu

ality

of l

ife.

Dev

elop

ed in

a c

linic

alpe

rspe

ctiv

e to

eval

uate

inco

ntin

ence

in w

omen

.

Men

and

Wom

en,

OA

B√

√√

√√

√√

(12

Wee

ks)

√

KH

Q T

rans

late

d in

45

Lang

uage

s. h

ttp://

proq

olid

.or

g/in

stru

men

ts/k

ing_

s_he

alth

_que

stio

nnai

re_k

hq

LIS

(Le

ices

ter

Impa

ctS

cale

) [9

0]

A c

ondi

tion

spec

ific

qual

ity o

f life

mea

sure

for

mal

es a

nd fe

mal

esw

ith u

rinar

y st

orag

esy

mpt

oms

of u

rgen

cy,

freq

uenc

y, n

octu

riaan

d in

cont

inen

ce.

Was

orig

inal

lyde

velo

ped

for

wom

enw

ith in

cont

inen

ceon

ly.

men

and

wom

en,

LUT

S√

√√

√

√

N

one

Fou

nd

MU

DI (

Mal

eU

roge

nita

l Dis

tres

sIn

vent

ory)

[109

,110

]G

rad

e C

To

addr

ess

the

dim

ensi

on o

f phy

sica

lhe

alth

, foc

usin

g on

both

er fr

om m

ultip

lesy

mpt

oms

asso

ciat

edw

ith u

rinar

yin

cont

inen

ce in

men

.C

reat

ed b

y el

imin

atin

gfo

ur g

ende

r sp

ecifi

cite

ms

from

UD

I and

IIQ.

Men

with

LUT

Sfo

llow

ing

ara

dica

lpr

osta

tect

om

y fo

rpr

osta

teca

ncer

√√

√N

one

Fou

nd

MU

SIQ

(M

ale

Urin

ary

Sym

ptom

Impa

ctQ

uest

ionn

aire

)[10

9,11

0]G

rad

e C

To

capt

ure

men

tal/p

sych

olog

ical

heal

th, s

ocia

l hea

lth,

and

glob

alpe

rcep

tions

of

func

tion

and

wel

l-be

ing

in m

en w

ithur

inar

y in

cont

inen

ce.

Cre

ated

by

elim

inat

ing

four

gen

der

spec

ific

item

s fr

om U

DI a

ndIIQ

.M

en, U

I√

√√

Non

e F

ound

N-Q

oL

( IC

IQ-N

qol

(Noc

turia

Qua

lity

ofLi

feQ

uest

ionn

aire

)[28

]G

rad

e A

To

asse

ss th

e im

pact

of n

octu

ria o

n th

equ

ality

of l

ife o

fpa

tient

sM

en a

ndW

omen

√√

√√

√√

N-Q

ol T

rans

late

d in

17

Lang

uage

sw

ww

. pro

luts

sh.c

om

OA

B-q

SF

(OA

B-q

Sho

rt F

orm

)[29

]G

rad

e A

A s

hort

ened

ver

sion

of

the

OA

B-q

to e

valu

ate

both

con

tinen

t and

inco

ntin

ent s

ympt

oms

of O

AB

and

thei

rim

pact

on

HR

QL

Men

and

Wom

enO

AB

√√

√√

√ (

12W

eeks

)√

OA

B-q

SF

Tra

nsla

ted

in 4

0La

ngua

ges

ww

w.p

rolu

tssh

.com

Rel

iab

ility

Val

idit

y

RO

Nam

e / G

rad

eP

urp

ose

of

To

ol

Po

pu

lati

on

Sam

ple

Inte

rnal

Co

nsi

-st

ency

Tes

t-re

test

Co

n-

ten

tC

rite

-ri

on

Co

n-

curr

ent

Dis

cr-

imin

ant

Res

po

nsi

ve-n

ess

(Tre

atm

ent

Du

rati

on

)

Psy

cho

-m

etri

cV

alid

atio

nin

Oth

erL

ang

uag

esA

vaila

ble

Lan

gu

ages

381

Tab

le 6

. S

um

mar

y o

f U

rin

ary

Inco

nti

nen

ce,O

AB

an

d L

UT

S P

RO

Mea

sure

s –

HR

QL

(co

nti

nu

ed)

Rel

iab

ility

Val

idit

y

PR

O N

ame

/ Gra

de

Pu

rpo

se o

f T

oo

l

Po

pu

la-

tio

nS

amp

le

Inte

rnal

Co

nsi

-st

ency

Tes

t-re

test

Co

n-t

ent

Cri

te-

rio

nC

on

-cu

rren

tD

iscr

-im

inan

t

Res

po

nsi

ve-n

ess

(Tre

atm

ent

Du

rati

on

)

Psy

cho

met

ric

Val

idat

ion

inO

ther

Lan

gu

ages

Ava

ilab

le L

ang

uag

es

OA

B-q

(IC

IQ-

OA

Bqo

l)(O

vera

ctiv

e B

ladd

erQ

uest

ionn

aire

) [2

9]G

rad

e A

To

eval

uate

bot

h co

ntin

ent a

ndin

cont

inen

t sym

ptom

s of

OA

Ban

d th

eir

impa

ct o

n H

RQ

L.D

evel

oped

from

focu

s gr

oups

of

men

and

wom

en, c

linic

ian

opin

ion,

and

a th

orou

ghlit

erat

ure

revi

ew

Con

tinen

tan

din

cont

inen

tO

AB

√√

√√

√√

(12

Wee

ks)

√

OA

B-q

Tra

nsla

ted

in 4

1La

ngua

ges

ww

w.p

rolu

tssh

.com

PR

AF

AB

(Pro

tect

ion,

Am

ount

,F

requ

ency

,A

djus

tmen

t, B

ody

imag

e )

[111

-113

]G

rad

e A

5 ite

m q

uest

ionn

aire

wid

ely

used

in th

e N

ethe

rland

s b

yph

ysio

ther

apis

ts a

ndre

sear

cher

s u

sed

to e

valu

ate

trea

tmen

t effe

cts

for

UI i

nw

omen

Wom

en,

UI

√√

√√

√√

Eng

lish,

Ara

bic

and

Dut

ch

IHI (

Urin

ary

Inco

ntin

ence

Han

dica

p In

vent

ory)

[114

]G

rad

e C

To

iden

tify

diffi

culti

es p

atie

nts

may

be

expe

rienc

ing

beca

use

ofth

eir

inco

ntin

ence

Eld

erly

wom

en, U

Idu

e to

detr

usor

inst

abili

ty√

Non

e F

ound

UIS

S (

Urin

ary

Inco

ntin

ence

Sev

erity

Sco

re)

[115

]G

rad

e A

Des

igne

d by

the

Fin

nish

Gyn

ecol

ogic

al S

ocie

ty’s

urog

ynec

olog

ic w

orki

ng g

roup

toas

sess

sym

ptom

sev

erity

and

impa

ct o

f urin

ary

inco

ntin

ence

on e

very

day

life

Wom

en,

UI

√√

√√

√N

one

Fou

nd

UQ

(U

rgen

cyQ

uest

ionn

aire

)[1

16,1

17]

Gra

de

B

To

asse

ss th

e se

verit

y an

dim

pact

of u

rinar

y ur

genc

ysy

mpt

oms

on h

ealth

-rel

ated

qual

ity o

f lif

e. V

AS

sca

le is

use

dto

mea

sure

the

impa

ct o

fur

inar

y ur

genc

y o

n ov

eral

lqu

ality

of

life,

the

seve

rity

ofur

genc

y th

e in

tens

ity o

fur

genc

y a

nd t

he d

isco

mfo

rtex

perie

nced

in

conj

unct

ion

with

urge

ncy.

Wom

en,

OA

B√

√√

√ (1

0 D

ays)

Non

e F

ound

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life (

BP

HQ

oL9)

(Ben

ign

Pro

stat

icH

yper

trop

hy H

ealth

-R

elat

ed Q

ualit

y of

Life

Que

stio

nnai

re)

[118

)G

rad

e A

To

ass

ess

the

impa

ct o

f B

PH

and

its tr

eatm

ent

on t

he q

ualit

yof

life

of p

atie

nts

Men

, BP

H√

√√

√√

√

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TM

/BP

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in 1

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http

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stru

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tic_h

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sup_

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ork

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cale

)[5

8]G

rad

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To

mea

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the

psyc

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pect

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ence

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I√

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d

382

to be used to assess LUTS in men [51] and minimallyinvasive therapies and drug treatments [52-55]. It isprimarily a questionnaire for the assessment of theoccurrence and bothersomeness of a wide range ofLUTS in men.

The scored short-form – ICSmaleSF, [25] wasdeveloped from the longer ICSmale questionnaire toassess LUTS in men.61 The short form has two majorscored sections: ICSmaleVS (voiding subscore)containing five questions (hesitancy, straining, reducedstream, intermittency, incomplete emptying), andICSmaleIS (incontinence subscore) containing sixquestions(urge, stress, unpredictable and nocturnalincontinence, urgency, postmicturition dribble).(25)The scores are obtained by simple addition. Theauthors indicate that questions to assess nocturia,frequency and impact on quality of life should beadded to provide full data, but these questions shouldnot be included in the score as they are separateconstructs [25]. The ICSmaleSF has been used instudies focusing on prostate cancer [56, 57] and onLUTS [51] as well as minimally invasive therapiesand drug treatments [52, 53].

4. INCONTINENCE IMPACT QUESTIONNAIRE (IIQ) AND IIQ-7

This questionnaire was developed to assess thepsychosocial impact of urinary incontinence in womenand consists of 30 items (24 on the degree to whichincontinence affects activities and 6 on the feelingsengendered) [58-60]. Scores are obtained overall orfor four subscales determined by factor and clusteranalyses: physical activity, travel, social relationships,and emotional health. The IIQ has been found to haveacceptable levels of reliability and validity across arange of studies [61-67]. The IIQ has also beenproduced in a short form comprising 7 items, alsowith evidence of validity and reliability [67, 68].Responsiveness of the IIQ has been assessed inseveral intervention studies [69-74].

5. I-QOL

This questionnaire was designed to be used in clinicaltrials to measure the impact of incontinence on menand women [75]. Psychometric information ontranslated versions of the I-QOL have been reportedfor French, Spanish, Swedish, German, Korean andThai language versions [76-78]. Other cultural andlinguistic adaptations are available but have not beenvalidated. In all countries, the use of three subscales,and an overall summary score was confirmed to beuseful.

6. KING’S HEALTH QUESTIONNAIRE (KHQ)

The King’s Health Questionnaire (KHQ) consists ofthree parts. The first section contains two questionsmeasuring general health and overall health relatedto urinary symptoms. The second section includes

19 questions divided into seven domains of quality oflife: incontinence impact, role limitations, physicallimitations, social limitations, personal relationships,emotions, sleep and energy, severity coping measures,general health perception, and symptom severity. Thethird section of the questionnaire comprises 11questions measuring the bother or impact of urinarysymptoms. The KHQ has demonstrated reliability andvalidity in men and women [24] [79-81] is availablein 37 languages [82-84]. Sensitivity to change hasbeen shown successfully in clinical trials where it hasbeen used to assess the HRQL improvement followingtreatment for patients with OAB, USI and mixedincontinence symptoms [79, 85-88]. A minimallyimportant difference has been derived to establishclinically meaningful interpretations of the KHQ scoresand a QALY measure has been derived from KHQscoring [89].

7. LEICESTER IMPACT SCALE (LIS)

The LIS is a condition-specific HRQL measure formen and women assessing the symptoms of urgency,frequency, nocturia, and incontinence. It is aninterviewer-administered tool so it is not a true PROas interviewer administration can introduce potentialbias into the patient responses. The LIS does haveutility in the clinical and research settings [90].

8. OVERACTIVE BLADDER SYMPTOM ANDHEALTH-RELATED QUALITY OF LIFE (OAB-Q) AND OAB-Q SF

The OAB-q is a 33-item questionnaire developed toassess the Symptom Bother (8 items) and HRQLimpact of OAB (25 items; 4 domains: Coping,Concern/Worry, Sleep, and Social Interaction.). It hasdemonstrated reliability, validity, responsiveness inmultiple clinical studies of men and women. (91) Aminimally important difference has been derived [91,92] to establish clinically meaningful interpretationsof the OAB-q scores and a QALY measure has beenderived from OAB-q scoring [93]. The 19-item short-form (OAB-q SF) is a six-item symptom bother scaleand 13-item HRQL scale that is a single score whichhas also demonstrated reliability, validity, andresponsiveness to change [94].

The OAB-q was the basis for the OAB-V8 AwarenessTool to screen for symptoms of OAB [95] and hasbeen used in a Parkinson disease patient population[96].

9. UROGENITAL DISTRESS INVENTORY (UDI)AND UDI-6

This questionnaire was developed in the US withwomen to assess the degree to which symptomsassociated with incontinence are troubling [59]. Itcontains 19 lower urinary tract symptoms and hasbeen shown to have high levels of validity, reliabilityand responsiveness in a community-dwelling popu-

383

lation of women with incontinence, (59) women over60 years, [97] women in two regions of Scotland [64].Responsiveness to changes in clinical status as aresult of treatment have been reported in a numberof areas: cadaveric fascia lata sling for stressincontinence, [72] comparing abdominal and vaginalprolapse surgery, [98] and the use of a simple urethralocclusive device [99].

A short-form version of the UDI (UDI-6 short form)has been shown to be valid and reliable in older adultmales and females, [100, 101] with demonstratedresponsiveness to resonstructuve pelvic surgery, [69]tension-free vaginal tape, [71, 73] and imipramine [74]

A number of other questionnaires noted in Table 6have been developed to assess symptoms or health-related quality of life impact of LUTS and/or UI,however they do not reach the highest level of gradingbecause they do not have the full complement ofpsychometric evaluation or robust data, or are lessrelevant for the assessment of UI than the question-naires reported above. Each is referenced in the tableshould further information be needed.

Patient satisfaction is the subjective, individualevaluation of treatment effectiveness and/or the serviceprovided by the healthcare system. Measures ofsatisfaction can include evaluation of accessi-bility/convenience, availability of resources, continuityof care, efficacy, finances, humaneness, informationgathering and giving processes, pleasantness ofsurroundings and perceived quality/competence ofhealth care personnel [119]. At its most basic level,satisfaction is a comprehensive evaluation of severaldimensions of health care based on patient expecta-tions and provider and treatment performance. As anoutcomes measure, patient satisfaction allows healthcare providers to assess the appropriateness oftreatment according to patient expectations. In chronicdiseases, where patients must live with treatment,patient satisfaction may be the distinguishing outcomeamong treatments with comparable efficacy [120].

Two patient satisfaction methods of promise withGrade B criteria are the BSW and OAB-S. Generallyresponsiveness cannot be assessed as there is nobaseline assessment of patient satisfaction withtreatment as no treatment has been given. Table 7below presents a summary of satisfaction instrumentsidentified in UI, OAB and other LUTS.

1. BENEFIT, SATISFACTION, AND WILLIN-GNESS (BSW) QUESTIONNAIRE

This 3-item questionnaire is designed to assess

treatment benefit, patient satisfaction with treatment,and patient willingness to continue treatment. TheBSW questionnaire was validated using data fromthree 12-week placebo-controlled trials of tolterodinein patients with OAB [121]. In this validation study,correlations were seen between patient-reportedtreatment satisfaction and improvements in the OAB-q, the KHQ, and micturition variables.

2. THE OVERACTIVE BLADDER TREATMENTSATISFACTION QUESTIONNAIRE (OAB-S)

The OAB-S is a 5 domain questionnaire whichevaluates control expectations, impact on daily livingwith OAB, OAB control, fulfillment of OAB medicationtolerability and satisfaction with control. Internalreliability coefficients were good (Cronbach’s alpha0.76-0.96), and test retest reliability has beenestablished (reliability coefficients 0.72-0.87) [122,123]. Cultural and linguistic differences wereconsidered early in the development process, andthe OAB-S is available in over sixteen languages[124].

In order to improve the detection of incontinence,OAB and other LUTS, several screening tools havebeen developed (Table 8). These tools help patientsself-describe symptoms and facilitate diagnosis ofLUTS by the clinician. Only the B-SAQ has beendesigned to screen for general lower urinary tractsymptoms (LUTS) rather than solely symptoms ofone condition. The majority of patients with LUTShave mixed urinary symptoms, and therefore aquestionnaire which can detect more than onesymptom complex may be more functional as ascreening tool in clinical practice than a highly specificquestionnaire. The Leiscester Impact Scale (LIS),OAB-V8, OAB-SS and QUID are all GradeA, short,simple to understand and complete, and easy tointerpret, however the LIS is interviewer, not patientadministered. Importantly, with screeners, responsi-veness is not assessed, however the sensitivity andspecificity of each tool is critical.

1. LEICESTER URINARY SYMPTOM QUESTIONNAIRE (LUSQ)

The LUSQ is a 10-item, interviewer-administeredquestionnaire developed to assess storage LUTS. Asan interviewer-administered tool, it is not a true PRObut is mentioned here as it may be useful in clinicalpractice and research when it is necessary or preferredto use interviewer administrative tools. The LUSQassesses the presence and severity of incontinence,urgency, frequency and nocturia, and the tool can beused for both male and female patients [127].

2. OAB-V8/OAB AWARENESS TOOL

The OAB-V8/OAB Awareness tool has been adapted

IV. SCREENING TOOLS

III. PATIENT SATISFACTION

II. OTHER UI/LUTS QUESTIONNAIRES

384

Tab

le 7

. S

um

mar

y o

f U

rin

ary

Inco

nti

nen

ce,

OA

B a

nd

LU

TS

PR

O M

easu

res

– P

atie

nt

Sat

isfa

ctio

n

Rel

iab

ility

Val

idit

y

PR

O N

ame

Pu

rpo

se o

f T

oo

lP

op

ula

tio

nS

amp

le

Inte

rnal

Co

nsi

-st

ency

Tes

t-re

test

Co

n-

ten

tC

rite

-ri

on

Co

n-

curr

ent

Dis

cr-

imin

ant

Res

po

nsi

ve-n

ess

(Tre

atm

ent

Du

rati

on

)

Psy

cho

-m

etri

cV

alid

atio

n in

Oth

erL

ang

uag

esA

vaila

ble

Lan

gu

ages

BS

W (

Ben

efit,

Sat

isfa

ctio

n w

ithtr

eatm

ent,

and

Will

ingn

ess)

[121

]G

rad

e B

To

capt

ure

patie

nts'

perc

eive

d be

nefit

,sa

tisfa

ctio

n w

ithtr

eatm

ent,

and

the

will

ingn

ess

toco

ntin

ue tr

eatm

ent

Men

and

Wom

en,

OA

B√

√√

ww

w.p

rolu

tssh

.com

EP

I (E

stim

ated

Per

cent

Impr

ovem

ent)

[125

]G

rad

e C

One

item

ques

tionn

aire

to g

ain

a pa

tient

'sim

prov

emen

t in

ape

rcen

t sca

leW

omen

,U

I,SU

I, M

UI

√√

(2-4

Wee

ks)

Non

e F

ound

GP

I (G

loba

lP

erce

ptio

n of

Impr

ovem

ent)

[125

]G

rad

e C

One

item

ques

tionn

aire

toas

sess

pat

ient

'sim

prov

emen

tW

omen

,U

I,SU

I, M

UI

√N

one

Fou

nd

OA

B-S

(O

vera

ctiv

eB

ladd

er S

atis

fact

ion

Que

stio

nnai

re)[

122,

123]

Gra

de

B

To

asse

ss p

atie

nts’

satis

fact

ion

with

OA

Btr

eatm

ent i

nclu

ding

/or

not m

edic

atio

n. T

hepr

e-m

edic

atio

nm

odul

e is

des

igne

d to

asse

ss th

e pa

tient

’sex

pect

atio

ns w

ithtr

eatm

ent a

nd im

pact

of O

AB

on

patie

nt’s

day

to d

ay li

fe

Men

and

Wom

en,

OA

B√

√√

√√

Non

e F

ound

/thou

gh m

entio

ned

in li

tera

ture

PS

Q (

Pat

ient

Sat

isfa

ctio

nQ

uest

ion)

[125

]G

rad

e C

One

item

ques

tionn

aire

use

d to

mea

sure

how

satis

fied

a su

bjec

tw

as w

ith a

pro

gram

Wom

en,

UI,S

UI,

MU

I√

Non

e F

ound

TB

S (T

reat

men

tB

enef

it S

cale

)[12

6]

A s

ingl

e-ite

m s

cale

used

to a

sses

s th

epa

tient

-rep

orte

dbe

nefit

s of

trea

tmen

tof

OA

B

Men

and

Wom

en,

OA

B√

√√

TB

S is

ava

ilabl

e in

oth

erla

ngua

ges

385

Tab

le 8

. S

um

mar

y o

f U

rin

ary

Inco

nti

nen

ce,

OA

B a

nd

LU

TS

PR

O M

easu

res

– S

cree

ner

s

Rel

iab

ility

Val

idit

y

PR

O N

ame

/ Gra

de

Pu

rpo

se o

f T

oo

lP

op

ula

tio

nS

amp

le

Inte

rnal

Co

nsi

-st

ency

Tes

t-re

test

Co

n-

ten

tC

rite

-ri

on

Co

n-

curr

ent

Dis

cri-

min

ant

Sen

siti

vity

/sp

ecif

icit

y

Val

idat

ion

in O

ther

Lan

gu

ages

Ava

ilab

le L

ang

uag

esB

-SA

Q (

Bla

dder

Sel

f-A

sses

smen

tQ

uest

ionn

aire

) or

Bla

dder

Con

trol

Sel

f-A

sses

smen

tQ

uest

ionn

aire

(BC

SQ

) [1

29]

Gra

de

A

A s

cree

ning

tool

for

the

pres

ence

of

both

erso

me

LUT

S in

Wom

enW

omen

√√

√√

√√

√

B-S

AQ

Q T

rans

late

d in

14

Ava

ilabl

eht

tp://

ww

w.m

api-

rese

arch

.fr/i_

03_l

ist_

urol

.htm

ISQ

(In

cont

inen

ceS

cree

ning

Que

stio

nnai

re)

[130

]G

rad

e C

5 ite

m q

uest

ionn

aire

deve

lope

d to

scr

een

for

inco

ntin

ence

inw

omen

Wom

en, U

I√

√√

Non

e F

ound

LU

SQ

(T

he L

eice

ster

Urin

ary

Sym

ptom

Que

stio

nnai

re)

[127

]G

rad

e A

A c

ondi

tion-

spec

ific

scre

ener

of s

tora

geLU

TS

( ur

genc

y,fr

eque

ncy,

noc

turia

and

inco

ntin

ence

).W

as o

rigin

ally

deve

lope

d fo

r w

omen

with

inco

ntin

ence

only

.

Men

and

Wom

en,

LUT

S√

√√

√N

one

Fou

nd

ME

SA

(M

edic

al,

Epi

dem

iolo

gica

l, an

dS

ocia

l Asp

ects

of

Agi

ng Q

uest

ionn

aire

)[1

31]

Gra

de

C

A 1

5 ite

m s

cree

ning

tool

for

urin

ary

inco

ntin

ence

infe

mal

e pe

lvic

med

icin

e an

dre

cons

truc

tive

surg

ery

patie

nts

Wom

en, U

I√

√

Tra

nsla

ted

in E

nglis

h an

d S

pani

shht

tp://

ww

w.n

cbi.n

lm.n

ih.g

ov/p

ubm

ed/1

7576

498?

ordi

nalp

os=

2&ito

ol=

Ent

rezS

yste

m2.

PE

ntre

z.P

ubm

ed.P

ubm

ed_R

esul

tsP

anel

.Pub

med

_RV

Doc

Sum

OA

B-S

S (O

vera

ctiv

eB

ladd

er S

ympt

omS

core

) [1

32]

Gra

de

A

A 7

item

ques

tionn

aire

valid

ated

to m

easu

reov

eral

l sym

ptom

seve

rity

due

to th

efo

ur in

dex

sym

ptom

sof

OA

B

Men

and

Wom

en,

LUT

S w

ithor

with

out

OA

B√

√√

√√

Non

e F

ound

OA

B-V

8 (O

AB

Aw

aren

ess

Too

l) [9

5]G

rad

e A

An

8-ite

m s

cree

ning

tool

for

use

in a

prim

ary

care

set

ting

to id

entif

y pa

tient

sw

ho m

ay h

ave

OA

B

Men

and

Wom

en,

OA

B√

√√

√O

AB

-V8

is T

rans

late

d in

32

Lang

uage

sht

tp://

ww

w.o

abq.

com

/tran

slat

ions

.htm

l

PU

F p

atie

nt s

ympt

omsc

ale

(Pel

vic

Pai

n,U

rgen

cy, a

ndF

requ

ency

) [1

33]

Gra

de

C

To

eval

uate

of

patie

nts

with

susp

ecte

d IC

/PB

S

Wom

en a

ndW

omen

,IC

/PB

S√

√

PU

F a

vaila

ble

in E

nglis

h an

d S

pani

shht

tp://

ww

w.n

cbi.n

lm.n

ih.g

ov/p

ubm

ed/1

5833

505?

ordi

nalp

os=

3&ito

ol=

Ent

rezS

yste

m2.

PE

ntre

z.P

ubm

ed.P

ubm

ed_R

esul

tsP

anel

.Pub

med

_RV

Doc

Sum

386

Tab

le 8

. S

um

mar

y o

f U

rin

ary

Inco

nti

nen

ce a

nd

LU

TS

PR

O M

easu

res

– S

cree

ner

s (c

on

tin

ued

)

Rel

iab

ility

Val

idit

y

PR

O N

ame

/ Gra

de

Pu

rpo

se o

f T

oo

lP

op

ula

tio

nS

amp

le

Inte

rnal

Co

nsi

-st

ency

Tes

t-re

test

Co

n-

ten

tC

rite

-ri

on

Co

n-

curr

ent

Dis

cr-

imin

ant

Sen

siti

vity

/sp

ecif

icit

y

Val

idat

ion

in O

ther

Lan

gu

ages

Ava

ilab

le L

ang

uag

es

QU

ID (

Que

stio

nnai

refo

r U

rinar

yIn

cont

inen

ceD

iagn

osis

)[12

8]G

rad

e A

6 ite

m q

uest

ionn

aire

used

to d

iagn

ose

stre

ss a

nd/o

r ur

gety

pes

of u

rinar

yin

cont

inen

ceW

omen

, UI

and

SU

I√

√√

√√

Non

e F

ound

3IQ

(T

hree

Inco

ntin

ence

Que

stio

nsQ

uest

ionn

aire

) [1

34]

Gra

de

C

A th

ree

item

ques

tionn

aire

use

d to

clas

sify

urg

e an

dst

ress

inco

ntin

ence

Wom

en, U

I

Psy

chom

etric

eval

uatio

n no

tre

port

ed√

UI (

Urin

ary

Inco

ntin

ence

Sco

re)

[135

]G

rad

e C

Dev

elop

ed in

Ger

man

used

to a

sses

UI

Wom

en, U

I√

Ava

ilabl

e in

Ger

man

US

P (

Urin

ary

Sym

ptom

Pro

file)

[139

]G

rad

e B

To

asse

ss u

rinar

ysy

mpt

oms

in m

ale

and

fem

ale

with

stre

ss, u

rge,

freq

uenc

y or

urin

ary

obst

ruct

ive

sym

ptom

sfo

r us

e in

clin

ical

prac

tice

toco

mpl

emen

t clin

ical

mea

sure

s an

ddi

agno

sis

Men

and

Wom

enst

ress

UI,

urge

UI,

freq

uenc

y,lo

w s

trea

m,

com

bine

dsy

mpt

oms

√√

√√

Non

e F

ound

I-P

SS

(In

tern

atio

nal

Pro

stat

e S

ympt

omS

core

) [1

37]

Gra

de

B

8- it

em q

uest

ionn

aire

used

to c

aptu

re th

ese

verit

y of

urin

ary

sym

ptom

s re

late

d to

beni

gn p

rost

atic

hype

rpla

sia.

Orig

inal

lyde

velo

ped

from

the

Am

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an U

rolo

gica

lA

ssoc

iatio

n S

ympt

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√√

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√

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SS

tran

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to 4

0 la

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387

from the OAB-q questionnaire; which is a 33 itemquestionnaire which assess symptom bother andHRQL impact of OAB [29]. The OAB-V8 is an 8-itemquestionnaire, which evaluates the symptoms ofoveractive bladder; namely urinary frequency, nocturia,urgency and urge incontinence. Responses are gradedon a 6 point Likert scale. Patients with an overall scoreof eight or more are directed to seek medical advice.This questionnaire is validated for use by men andwomen [98].

3. OAB-SS

The OAB-SS is a validated A 7-item questionnairevalidated to measure overall symptom severity due tothe four index symptoms of OAB. It quantifies allsymptoms of OAB in men and women. The OAB-SSincludes a detailed evaluation of the urgency symptom.Responses are graded on a 5 point Likert scale.

4. QUESTIONNAIRE FOR URINARYINCONTINENCE DIAGNOSIS(QUID)

The QUID is a 6-item patient admisitered questionnairedeveloped to idenitify and differentiate stress vs urgeincontinence. There are 3 items each related to stressand urge incontinence. Scoring is 0 (not at all) to 5 (allthe time) for each response. The tool was developedfor use with females [128].

Measures that can be used to assess how botheredpatients are by urinary symptoms are included inTable 9. The Patient Perception of Bladder Condition[138] and the Urogenital Distress Inventory are the onlyGrade A recommend instrument. There are severalGrade B and C measures which assess bother forincontinence and LUTS.

1. PATIENT PERCEPTION OF BLADDER CONDITION (PPBC)

The PPBC is a single item questionnaire designed torapidly assess patients’ perception of their bladdercondition [138].

The questionnaire asks patients to choose one of 6statements that best describes their present bladdercondition. The scale was validated during two large12-week clinical studies evaluating the efficacy andtolerability of Tolterodine in patients with OAB. Patientstaking part in the studies completed the PPBC, OAB-q, KHQ and bladder diaries. Baseline and week 12data was used for statistical analysis. PPBC scoreswere well correlated with OAB-q questionnaire scoresand bladder diary variables. Correlations of the KHQand PPBC were significant for all KHQ domains withthe exception of the general health perception domain.The scale was found to be responsive to change in

OAB symptoms and to have discriminant validity asreflected in the OAB-q, KHQ score and bladder diarychanges. The PPBC has also shown to have good testretest reliability [117]. This scale has been widelyused in studies evaluating the use of drug therapy inpatients with OAB [139-141].

2. UROGENITAL DISTRESS INVENTORY (UDI-6)

The UDI-6 is a six item questionnaire which assessesthe presence and bother of 6 lower urinary tractsymptoms [101]. The UDI-6 assesses types ofincontinence, frequency, difficulty emptying bladder andpain/discomfort in the lower abdomen/genitalia. Theresponse options are 0-3. The instrument hasdemonstrated validity, reliability and responsiveness[142].

Several instruments have been developed specificallyto assess urinary urgency, which is defined by theInternational Continence Society as “the complaintof a sudden compelling desire to pass urine which isdifficult to defer “[147]. Urgency is the principlesymptom of OAB [148], and, as such, assessing theeffect of treatment on this symptom and its impact onHRQL is important. With any measure designed toevaluate urgency, patients must be able to distinguishbetween the normal desire to urinate (urge) and thedifficult-to-postpone need to urinate (urgency) [149,150]. Wording thus becomes critical in the developmentof urgency assessment measures. Chapple and Wein[151] make a case for describing urgency as a“compelling desire to void in which patients fearleakage of urine” as a means of distinguishing thisabnormal sensation from the normal need to void.However, some patients may have a sensation ofurgency without fear of leakage, further complicatingattempts to define urgency. Importantly, with some ofthese scales, patients have the option of indicating thatthey experienced UUI (an event) rather than thestrongest feeling of urgency (a sensation) itself. Insuch cases, patients who have severe urgency, butnot UUI, do not have an option for endorsing thehighest (worst) value, because they are not incontinent.Urgency severity scales that include a UUI responseoption thus may be less useful than those that do notbecause such scales are trying to measure 2 thingsat once, both urgency and UUI.

Several instruments have been developed to assessurinay urgency these are summarized in Table 10.Given no urgency measures have a Grade A rating,a brief summary of each urgency measure is presentedbelow.

Urgency Perception Scale was designed for use inclinical trials to evaluate patient-perceived urgency

VI. ASSESSING THE IMPACT OFURGENCY

V. ASSESSING SYMPTOM BOTHERAND OVERALL BOTHER

388

Tab

le 9

. S

um

mar

y o

f U

rin

ary

Inco

nti

nen

ce,

OA

B a

nd

LU

TS

PR

O M

easu

res

– S

ymp

tom

Bo

ther

Rel

iab

ility

Val

idit

y

PR

ON

ame

/ Gra

de

Pu

rpo

se o

f T

oo

lP

op

ula

tio

nS

amp

le

Inte

rnal

C

on

si-

sten

cyT

est-

rete

stC

on

-te

nt

Cri

te-

rio

nC

on

-cu

rren

tD

iscr

-im

inan

t

Res

po

nsi

ve-n

ess

(Tre

atm

ent

Du

rati

on

)

Psy

cho

-m

etri

cV

alid

atio

nin

Oth

erL

ang

uag

esA

vaila

ble

Lan

gu

ages

PG

I-I a

nd

PG

I-S

(Pat

ient

Glo

bal

Impr

essi

on o

fS

ever

ity a

nd o

fIm

prov

emen

t)[1

43]

Gra

de

C

Tw

o si

ngle

-que

stio

n gl

obal

inde

xes

to m

easu

re s

ympt

ombo

ther

rel

ated

to u

rinar

yin

cont

inen

ceW

omen

,S

UI

√√

(12

Wee

ks)

Non

e F

ound

PO

SQ

(P

rimar

yO

AB

Sym

ptom

Que

stio

nnai

re)

[117

]G

rad

e C

To

asse

ss w

hich

sym

ptom

of

OA

B is

the

mos

t bot

hers

ome

topa

tient

s

Men

and

Wom

en,

OA

B√

√N

one

Fou

nd

PP

BC

(P

atie

ntP

erce

ptio

n of

Bla

dder

Con

ditio

n)[1

38]

Gra

de

A

To

asse

ss p

atie

nts’

sub

ject

ive

impr

essi

on o

f the

ir cu

rren

tur

inar

y pr

oble

ms.

Dev

elop

ed fo

rpa

tient

s w

ith u

rinar

y pr

oble

ms

asa

glob

al a

sses

smen

t of b

ladd

erco

nditi

on a

nd is

rec

omm

ende

das

a g

loba

l out

com

e m

easu

re fo

rur

inar

y in

cont

inen

ce b

y th

eE

urop

ean

Med

icin

e E

valu

atio

nA

ssoc

iatio

nM

en a

ndW

omen

√√

√√

PP

BC

is tr

ansl

ated

in 2

2 La

ngua

ges

ww

w.p

rolu

tssh

.com

SP

I (S

ympt

omP

robl

emIn

dex)

[144

]G

rad

e B

To

mea

sure

how

trou

bles

ome

the

patie

nts

find

thei

r ur

inar

ysy

mpt

oms

Mal

e, B

PH

√√

√√

SP

I is

tran

slat

ed in

19

lang

uage

sht

tp://

proq

olid

.org

/inst

rum

ents

/sy

mpt

om_p

robl

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ndex

_spi

SS

I an

d S

II(S

ympt

omS

ever

ity In

dex

and

Sym

ptom

Impa

ct In

dex

for

stre

ssin

cont

inen

ce in

wom

en)[

145]

Gra

de

C

To

mea

sure

str

ess

inco

ntin

ence

seve

rity

and

impa

ct o

rbo

ther

som

e of

sym

ptom

s. T

his

ques

tionn

aire

was

dev

elop

edan

d ad

min

iste

red

to w

omen

unde

rgoi

ng s

tres

s in

cont

inen

cesu

rger

yW

omen

,S

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√√

√√

SS

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SII

tran

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ed in

5 la

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http

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erity

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ympt

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mpa

ct_i

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_str

ess_

inco

ntin

ence

_in

_wom

en_s

si_a

nd_s

ii

UI-

4 (U

rinar

yIn

cont

inen

ce -

4Q

uest

ionn

aire

[146

]G

rad

e C

To

asse

s ho

w p

atie

nts

are

both

ered

by

urin

ary

inco

ntin

ence

Wom

en, U

I√

Ava

ilabl

e on

ly in

Spa

nish

http

://w

ww

.ncb

i.nlm

.nih

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med

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4886

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ubm

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Res

ults

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el.P

ubm

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VD

ocS

um

389

[152]. This instrument consists of a single questionasking patients to describe their typical experiencewhen they feel the need to urinate. The 3 possibleresponses are “I am usually not able to hold urine,”“I am usually able to hold urine until I reach the toiletif I go immediately,” and “I am usually able to finishwhat I am doing before going to the toilet.” [152]. Thisscale was validated in a clinical trial evaluating theefficacy of tolterodine in treating OAB symptoms;[152] however, its limited responsiveness maypreclude its usefulness in clinical practice [153].

Indevus Urgency Severity Scale asks patients to ratetheir level of urgency on a 4-point scale, from 0 (nourgency) to 4 (extreme urgency discomfort that abruptlystops all activity/tasks) [154]. The scale has beenvalidated in a clinical trial of trospium in patients withOAB, [154] but Chapple et al [153] question whetherthis scale actually measures urgency or just the normalurge to void.

Urinary Sensation Scale is a 5-point scale rangingfrom 1 (no urgency; can continue activities until it isconvenient to use the bathroom) to 5 (urge incon-tinence; extreme urgency discomfort, cannot holdurine and have a wetting accident before arriving atthe bathroom) [155]. The content validity of this scalewas established through a physician survey and patientinterviews [155].

Urgency Rating Scale, recommended by theEuropean Medicines Evaluation Agency, consists ofa 5-point rating scale to be rated with every void,ranging from 1 (no urgency; I felt no need to emptymy bladder but did so for other reasons) to 5 (urgeincontinence; I leaked before arriving at the toilet)[16].This scale was used in a tolterodine clinical trial,in which responses on this scale were used to calculatesum urgency, a measure that accounts for changesin both urgency and frequency [156].

Many women present with vaginal symptoms andpelvic organ prolapse (POP) is frequently implicated.A traditional clinical history is usually used in an effortto assess the symptoms experienced by the patientand a thorough clinician will try to gain insight intohow these symptoms are impacting on the patient’slife. A detailed description of the clinical techniques ofpelvic floor assessment are described in anotherchapter in this book. However, symptoms do notalways correlate with objective examination findings.Indeed the clinical assessment itself can beinconsistent, depending upon the position of thepatient, whether they have been standing for a

VII. QUESTIONNAIRES TO ASSESSSYMPTOMS AND HEALTH RELATED

QUALITY OF LIFE IMPACT OF PELVICORGAN PROLAPSE

Tab

le 9

. S

um

mar

y o

f U

rin

ary

Inco

nti

nen

ce,

OA

B a

nd

LU

TS

PR

O M

easu

res

– S

ymp

tom

Bo

ther

(co

nti

nu

ed)

Rel

iab

ility

Val

idit

y

PR

ON

ame

/ Gra

de

Pu

rpo

se o

f T

oo

lP

op

ula

tio

nS

amp

le

Inte

rnal

Co

nsi

-st

ency

Tes

t-re

test

Co

n-

ten

tC

rite

-ri

on

Co

n-

curr

ent

Dis

cr-

imin

ant

Res

po

nsi

ve-n

ess

(Tre

atm

ent

Du

rati

on

)

Psy

cho

met

ric

Val

idat

ion

inO

ther

Lan

gu

ages

Ava

ilab

le L

ang

uag

es

UD

I (U

roge

nita

lD

istr

ess

Inve

ntor

y)[6

4]G

rad

e B

To

asse

s sy

mpt

om b

othe

rre

late

d to

urin

ary

inco

ntin

ence

.U

DI i

s m

eant

to c

ompl

emen

tth

e IIQ

, was

dev

elop

ed a

t the

sam

e tim

e as

the

IIQ.

Wom

en, U

I,S

UI

√√

√√

√√

Ava

ilabl

e in

3 la

ngua

ges

(Eng

lish,

Ital

ian

and

Ara

bic)

UD

I-6

(Uro

geni

tal

Dis

tres

s In

vent

ory

-6)

[142

]G

rad

e A

To

asse

ss L

UT

S b

othe

r,in

clud

ing

inco

ntin

ence

, in

wom

en.

Wom

en√

√√

√√

Ava

ilabl

e in

3 la

ngua

ges

(Eng

lish,

Tur

kish

and

Ara

bic)

390

Tab

le 1

0. S

um

mar

y o

f U

rin

ary

Inco

nti

nen

ce,

OA

B a

nd

LU

TS

PR

O M

easu

res

– U

rgen

cy

Rel

iab

ility

Val

idit

y

PR

ON

ame/

Gra

de

Pu

rpo

se o

f T

oo

lP

op

ula

tio

nS

amp

le

Inte

rnal

Co

nsi

-st

ency

Tes

t-re

test

Co

n-

ten

tC

rite

-ri

on

Co

n-

curr

ent

Dis

cr-

imin

ant

Res

po

nsi

ve-n

ess

(Tre

atm

ent

Du

rati

on

)

Psy

cho

me-

tric

Val

idat

ion

in O

ther

Lan

gu

ages

Ava

ilab

le L

ang

uag

es

IUS

S (

Inde

vus

Urg

ency

Sev

erity

)[1

57]

Gra

de

A

Use

d to

qua

ntify

the

leve

lof

urg

ency

ass

ocia

ted

with

eac

h to

ilet v

oid

asm

easu

red

durin

gst

anda

rd v

oidi

ng d

iarie

s.

OA

B w

ithur

genc

yin

cont

inen

ce,

men

and

wom

en√

√√

√√

(12

Wee

ks)

Non

e F

ound

SU

IQ(S

tres

s/U

rge

Inco

ntin

ence

Que

stio

nnai

re)

[158

]G

rad

e C

Tw

o ite

m q

uest

ionn

aire

used

to d

iffer

entia

tebe

twee

n sy

mpt

oms

ofst

ress

and

urg

e ur

inar

yin

cont

inen

ceW

omen

, UI

√√

Non

e F

ound

UD

I (U

roge

nita

lD

istr

ess

Inve

ntor

y)[6

4]G

rad

e B

To

asse

s sy

mpt

ombo

ther

rel

ated

to u

rinar

yin

cont

inen

ce. U

DI i

sm

eant

to c

ompl

emen

t the

IIQ, w

as d

evel

oped

at t

hesa

me

time

as th

e IIQ

.W

omen

, UI,

SU

I√

√√

√√

√A

vaila

ble

in 3

lang

uage

s(E

nglis

h, It

alia

n an

d A

rabi

c)

UP

S (

Urg

ency

Per

cept

ion

Sco

re)[

159]

Gra

de

C

self-

repo

rt 5

item

OA

Bqu

estio

nnai

re u

sed

for

grad

ing

the

urge

to v

oid

and

asse

ssin

g th

e re

ason

why

indi

vidu

als

usua

llyvo

idM

en a

ndW

omen

√√

√√

Non

e F

ound

Non

e F

ound

UP

S (

Urg

ency

Per

cept

ion

Sca

le)

[152

]G

rad

e B

To

asse

ss th

e se

verit

y of

urge

ncy

– w

heth

er o

r no

tur

genc

y, th

e su

dden

and

com

pelli

ng d

esire

tour

inat

e sh

ould

hav

e a

seve

rity

mea

sure

isde

bate

d. T

he U

PS

was

desi

gned

for

use

incl

inic

al tr

ials

to e

valu

ate

patie

nt p

erce

ived

urge

ncy

OA

B(d

oubl

e-bl

ind)

, men

and

wom

en√

√√

Non

e F

ound

UR

IS-2

4 (U

rge

Impa

ct S

cale

)[1

60]

Gra

de

C

To

asse

ss o

f the

impa

ctof

the

mos

t com

mon

form

of U

I in

olde

r pe

rson

sO

lder

pers

ons,

UI

√√

√√

Non

e F

ound

UR

S (

Urg

ency

Rat

ing

Sca

le)

[161

]G

rad

e C

5-po

int s

cale

to b

e us

edco

ncur

rent

ly w

ith v

oidi

ngdi

arie

s to

mea

sure

the

leve

l of u

rgen

cyas

soci

ated

with

eac

hm

ictu

riatio

n. A

dvoc

ated

by th

e E

ME

A C

PM

PP

sych

omet

ric e

valu

atio

n no

t rep

orte

dN

one

Fou

nd

391

prolonged time or have just used a pessary or tampon.While there is a little research defining the associationbetween specific symptoms and support defects [164-166], measuring subjective outcome after treatmentis problematic. Unlike lower urinary tract dysfunction,where increasingly patient-completed methods suchas diaries and questionnaires are being used tomeasure outcome, there are fewer such instrumentsavailable for POP. Clinician based history isinconsistent, disease impact may not be assessed,leading questions can be asked and patients may beunwilling to volunteer symptoms, particularly aftersurgical intervention, for fear of appearing ungratefulor a nuisance. Consequently, despite the highlyprevalent nature of this condition we have little ideahow intervention, which is frequently surgical, alterssymptoms and HRQL. As for incontinence, question-naires to assess symptoms and HRQL impact of pelvicorgan prolapse would be highly desirable.

For POP, the Committee examined the quality of thepsychometric evidence and only where publisheddata were scientifically sound was the label ‘withrigour’ allowed. The Committee noted that this is adeveloping area with few questionnaires currentlyreaching the highest levels of evidence. Thus threegrades of recommendation were established (Table11).

1. GRADE A

a) Pelvic Floor Distress Inventory (PFDI) andPFIQ (Pelvic Floor Impact Questionnaire)

This questionnaire is an adaptation of the well-established UDI with the aim of developing acomprehensive condition specific instrument to assessimpact from pelvic organ prolapse and other aspectsof colorectal-anal dysfunction, as well as LUTS [167].

Tab

le 1

0. S

um

mar

y o

f U

rin

ary

Inco

nti

nen

ce,

OA

Ban

d L

UT

S P

RO

Mea

sure

s –

Urg

ency

(co

nti

nu

ed)

Rel

iab

ility

Val

idit

y

PR

O N

ame

Pu

rpo

se o

f T

oo

lP

op

ula

tio

nS

amp

le

Inte

rnal

Co

nsi

-st

ency

Tes

t-re

test

Co

n-

ten

tC

rite

-ri

on

Co

n-

curr

ent

Dis

cr-

imin

ant

Res

po

nsi

ve-n

ess

(Tre

atm

ent

Du

rati

on

)

Psy

cho

met

ric

Val

idat

ion

inO

ther

Lan

gu

ages

Ava

ilab

le L

ang

uag

es

US

S (

Urin

ary

Sen

satio

n S

cale

)[1

62]

Gra

de

C

To

asse

ss th

e im

pact

of

urge

ncy

with

pat

ient

sw

ith O

AB

Uro

logi

sts

orur

ogyn

ecol

o-gi

sts,

Sur

vey

resp

onde

nts

with

OA

Bsy

mpt

oms

N/A

√N

/AN

/AN

/AN

/AN

one

Fou

nd

UU

Sca

le (

10-I

tem

Sca

le to

Mea

sure

Urin

ary

Urg

ency

)[1

63]

Gra

de

B

10 it

em q

uest

ionn

aire

use

to m

easu

re u

rinar

yur

genc

yM

en a

ndW

omen

√√

√N

ON

EN

one

Fou

nd

Table 11. Criteria for recommendation of question-naires for POP at the Fourth Consultation

Grade of recommendation Evidence required (published)

Recommended (Grade A) Validity, reliability and responsiveness established with rigour.

(Grade B) Validity and reliabilityestablished with rigour, or validity, reliability and responsiveness indicated.

With potential (Grade C) Early development –further work requiredand encouraged

392

The PFDI retains the 19 original items of the UDI,and adds 9 items related to lower urinary tractsymptoms that are common in women with pelvicfloor disorders. The three original subscales of theUDI are retained (i.e., obstructive, irritative/discomfort,and stress). Psychometric testing included internalreliability (PFDI Cronbach’s alpha 0.88, PFIQ 0.98),1 week test-retest (interclass correlation coefficientPFDI 0.87, PFIQ 0.86).

Both correlated with stage of prolapse (Spearmancorrelation coefficient for pelvic organ prolapse distressinventory and impact questionnaire 0.32 p<0.01, 0.33p<0.01). Respon-siveness has not yet been tested.

PFIQ is an adaptation of the IIQ to assess quality oflife impact in women with pelvic floor disorders. Itcontains items included in the original IIQ and newitems related to other pelvic floor disorders. PFIQ has3 scales including 92 items: IIQ (30 items), Colorectal-anal impact Questionnaire (CRAIQ) (31 items) andPelvic Organ Prolapse impact Questionnaire (POPIQ)(31 items).

Each scale includes 4 domains of travel, social,emotional and physical activity. The psychometricproperties of the PFIQ were evaluated in 100 femalepatients with pelvic floor dysf-unction [167].

The PFIQ showed good validity; each of IIQ, CRAIQand POPIQ revealed significant correlation withincontinence episode and number of pad use perweek, faecal incontinence per week and stage ofprolapse, respectively. Internal consistency wasexcellent (Cronbach alpha 0.98) and test-retestreproducibility was high (overall ICC 0.86 rangingfrom 0.69 to 0.92). A French language version hasbeen produced [168].Responsiveness has not yetbeen evaluated.

Responsiveness of the PFDI and PFIQ was tested inwomen with pelvic organ prolapse undergoing surgicaland conservative management with vaginal pessaries.Women undergoing surgical treatment for prolapsereported significantly greater improvement in allsubscales of the PDFI and PFIQ than those patientstreated with pessaries.

The PFDI was found to be more responsive to changethan the PFIQ [169]. French and Spanish versions ofboth the PFIQ and PFDI have been produced [170,171]. Long forms of the PFDI and PFIQ have alsobeen validated for telephone administration [172].

Short forms of the PFDI and PFIQ questionnaireshave been developed. Reliability, validity andresposiveness were tested in a populatin of patientsbefore and 3-6 months after pelvic floor surgery. Theshort form of the PFIQ and PFDI correlated well withthe long form versions of the questionnaires (r=0.88-0.94) [173] (Table 12).

Table 12. Recommended questionnaires for theevaluation of symptoms and quality of life impact ofpelvic organ prolapse

Grade A New (recommended)

Pelvic Floor Distress Inventory (PFDI) [167]

Pelvic Floor Impact Questionnaire (PFIQ) [167]

Grade B

The electronic Personal Assessment Questionnaire –Pelvic Floor (ePAQ-PF) [174]

Grade C (with potential)

P-QOL/St. Mary’s Questionnaire [175]

Pelvic Floor Dysfunction Questionnaire [176]

Danish Prolapse Questionnaire [164]

2. GRADE B

• e-PAQ Electronic Pelvic Floor SymptomsQuestionnaire

The electronic Personal Assessment Questionnaire– Pelvic Floor (ePAQ-PF) is an interactivecomputerised system that comprehensively measurespelvic floor symptoms and their impact on HRQL inwomen. It comprises a maximum of 124 items in 4dimensions (Urinary, Bowel, Vaginal & Sexual) andincludes 19 scored domains:

The original 14 domain version underwent psycho-metric testing in primary and secondary care, whereit was found to be valid, reliable and acceptable(Radley et al 2006) [177]. Since this initial validationstudy, a further 5 domains have been added including:Irritable Bowel, Dyspareunia, Vaginal Capacity, UrinaryVoiding and General Sex Life [178]. Each domain isscored on a scale of zero (best possible health) to 100(worst possible health) and the symptom domainsalso each provide a 4-point scale. Recent tests ofdata quality on this version of ePAQ-PF supportedthe 19 domain structure of the instrument and itsreliability and validity (Jones et al, 2008) [179]. Theresponsiveness of the instrument has also beendemonstrated [177].

3. GRADE C

Several other questionnaires of Grade C level orbelow have been developed in the area of POP. Ifthe validation of these instruments progress they maybe useful for researchers. These include:

• P-QOL/St Mary’s Questionnaire [175] [180] -PelvicFloor Dysfunction Questionnaire [176]

• -Danish prolapse questionnaire [164]

• Pelvic symptom inventory and quality of lifequestionnaire [181,182]

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• Pelvic floor questionnaire [183]

• Sheffield prolapse symptom questionnaire [178]

• ICIQ-Vaginal Symptoms (In development). [30],[184].

A range of questionnaires have been developed toidentify the severity of faecal incontinence (FI) and itsinfluence on HRQL. Despite the large number, onlya few are in regular use in research practice, and fewservices routinely use them in clinical assessment. Dueto the close overlap between faecal incontinence andother pelvic floor disorders (in particular urinaryincontinence), some of those questionnaires used forother pelvic disorders also include items to coverfaecal incontinence. For similar reasons, items relatingto faecal incontinence have often been included inquestionnaires addressing general gastro-intestinaland colo-rectal function, as well as condition specificinstruments in such areas as irritable bowel syndromeand inflammatory bowel disease, conditions whichare commonplace in colorectal practice as well as inother specialties dealing with pelvic floor disorders[185, 186]. It is also important to remember that thenormal range of bowel function is broad, that bowelfunction may be highly variable within individualswithout significant pathology. Consequently instru-ments in this field are likely to lack a degree ofsensitivity or specificity for the specific bowel disorderssuch as IBS, IBD evacuation disorder and constipation.

Anal incontinence and bowel evacuation are intrin-sically related to pelvic floor function and it may beinappropriate to consider bowel function purely interms of continence and constipation. Evacuatorydysfunction may result from a variety of underlyingpathologies including outlet obstruction, slow transitor other mechanical, pharmacological, metabolic,endocrine and neurogenic abnormalities [187]. Analincontinence occurs in both sexes, but is morecommon in women than men [188]. Symptoms areconsidered crucial to diagnosis as specific symptomsare thought to reflect the underlying pathophy-siology[189]. Thus, urgency (the inability to defer defecation)and urgency incontinence are thought to indicate lossof voluntary control due to impaired external analsphincter function, whereas passive incontinence isthought to indicate impairment of the smooth muscleof the internal sphincter.

For FI, the Committee examined the quality of thepsychometric evidence and noted that this is a

developing area with questionnaires currently reachingthe highest level of evidence. A FI outcomes measureis currently in development by the ICIQ (Table 3). Acommonly used score for FI (Wexner), for example,does not appear to have published data related to itspsychometric properties and thus while it is usedwidely cannot be recommended by the committee.The grades of recommendation are as outlined inprevious sections (Tables 13,14).

Table 13. Criteria for recommendation of question-naires for faecal incontinence

Grade of recommendation Evidence required (published)

(Grade A) Validity, reliability and responsiveness established with rigour.

(Grade B) Validity and reliability established with rigour, or validity, reliability and responsiveness indicated.

With potential (Grade C) Early development – further work required and encouraged

Table 14. Recommended questionnaires for the eva-luation of symptoms and quality of life impact offaecal incontinence

Grade A

None

Grade B

Faecal Incontinence Quality of Life Scale [190]

Manchester Health Questionnaire [191]

Birmingham Bowel and Urinary SymptomsQuestionnaire (BBUS-Q) [192, 193]

Grade C (with potential)

Wexner score [194]

St Mark’s score [195]

Faecal Incontinence Survey [196]

Elderly Bowel Symptoms Questionnaire [197]

Postpartum Flatal and Faecal Incontinence Quality ofLife Scale [198]

Bowel Disease Questionnaire [199]

Gastrointestinal Quality of Life Index [200]

VIII. QUESTIONNAIRES TO ASSESSSYMPTOMS AND HRQL IMPACT OF

FAECAL INCONTINENCE

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1. GRADE A

No questionnaires are currently available at this level.

2. GRADE B

a) Faecal Incontinence Quality of Life Scale

The 29-item Faecal Incontinence Quality of Life Scaledeveloped and tested by Rockwood et al measuresimpact of anal incontinence over four scales of HRQL;Lifestyle (10 items), Coping/behaviour (9 items),Depression/Self perception (7 items) and Embar-rassment (3 items) [190]. The instrument was designedto measure the effect on quality of life of treatment forindividuals with faecal incontinence. A panel of colo-rectal surgeons and researchers generated the items.Psychometric properties were tested in 118 patientswith faecal incontinence and 72 controls.

The question-naire showed good discriminant validity,with significant differences between patients withfaecal incontinence and those with other gastro-intestinal disorders. There were also significantcorrelations with selected subscales of the SF-36.Test-retest reliability at a mean interval of 8 days wassatisfactory, with correlations for the 4 scales of 0.8 -0.96. Internal consistency of the 4 scales was >0.7.The instrument does not measure physical symptomseverity and has not been tested in asymptomaticcontrols, but appears to offer a valid and reliablemeasure of the impact of faecal incontinence on qualityof life in men and women with this condition [190].However, in order to demonstrate discriminant validity,the researchers deemed it necessary to modify thequestionnaire for use in controls. Its use in anunscreened population is as yet unreported, and noresponsiveness data have yet been produced.

b) Manchester Health Questionnaire

This questionnaire consists of items adapted fromthe King’s Health Questionnaire [191]. It uses thesame basic structure and format but items have a 5-point response scale (rather than the 4-point scale inthe KHQ). It includes items in the 8 domains of HRQLas well as a symptom severity scale. Face validitywas assessed by interview with 15 patients with faecalincontinence. Test-retest reliability was measured(Pearson correlation > 0.8 in all 9 domains).

The questionnaire was posted to 236 women withfaecal incontinence, of which 159 returned completedquestionnaires. 121 performed test-retest at a meaninterval of 20 days. Cronbach’s alpha was > 0.7 in alldomains tested, indicated adequate internalconsistency.

Convergent validity was assessed by comparisonwith responses in the SF-36, which showed significantcorrelations between domains of the 2 instruments.Data relating to women without faecal incontinenceor unscreened women are not yet available. The

questionnaire’s sensitivity to change is also not yetestablished.

c) Birmingham Bowel and Urinary SymptomsQuestionnaire (BBUS-Q)

This is a 22-item questionnaire developed to evaluatesymptoms of both bowel and urinary dysfunction inwomen which has a published scoring manual [192,193]. Items were generated by a panel of cliniciansand scientists and following review of existinginstruments in the literature. The instrument was testedin the gynaecology departments of three hospitals, aurogynaecology clinic, a functional bowel clinic anda general practice. A total of 630 women completedthe questionnaire; 379 women awaiting hysterectomy,45 women following hysterectomy 65 women referredwith functional bowel and/or urinary symptoms and 141asymptomatic controls.

The content, construct and criterion validity, internalconsistency, reliability and responsiveness of thequestionnaire were measured. Low levels of missingdata, peer and patient reports supported face andcontent validity.

Factor analysis showed a clinically relevant four-factorstructure: Constipation, Evacuatory function, Analincontinence and Urinary symptoms with low contentreplication able to distinguish between patient groups,indicating good internal structure. Comparison withclinical, anorectal physiological, videoproctographic,transit time and urodynamic test results supportedthe instrument’s criterion validity. Key domain questionanalysis and Cronbach's alphas showed internalconsistency. Kappa values and limits of agreementdemonstrated good test-retest reliability. Someresponsiveness data have been produced.

The authors recommended the questionnaire for useas both a research tool and as a useful clinicalmeasure. This questionnaire also forms a core elementin an electronic pelvic floor symptoms assessmentquestionnaire (e-PAQ) (see above).

3. QUESTIONNAIRES WITH POTENTIAL[GRADE C]

There are several questionnaires on faecalincontinence which have not yet reached Grade Cstatus. They may undergo further development andbe of use in future research:• Wexner score [194]• St. Mark’s score [195]• Faecal incontinence survey [184,185,190,196,

201, 202]• Elderly Bowel Symptom Questionnaire (EBSQ)

[197]. • Postpartum Flatal and Faecal Incontinence Quality

of life Scale [198].• Bowel Disease Questionnaire [199]

• Gastro-intestinal Quality of Life index (GIQLI) [200]

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Sexual function may be regarded as a dimension oraspect of overall HRQL, for which a number ofdimension-specific measures have been developedand validated. There is a wide choice of availableinstruments, the selection of which will depend onthe clinical or research setting where the instrumentis to be employed. Established and widely usedmeasures that have been shown to be valid, reliableand responsive are clearly desirable, however thefeasibility and appropriateness of using a particularinstrument in a particular setting must also beconsidered. A large number of different instrumentsexist in this field, which aim to evaluate specific aspectsof sexual function and sexual health. A number havebeen specifically developed or adapted to examinesexual function in patients with pelvic floor disorderssuch as incontinence.

Clinicians who treat sexual problems often prefer touse unstructured rather than structured interviews orquestionnaires in clinical practice as an unstructuredapproach allows the tailoring of questions to suit thecouple or the individual being assessed. Unstructuredinterviews enable the clinician to support patients whofeel vulnerable and encourage discussion. Theexperienced clinician hopes to have an appreciationof the information required to make the correctdiagnosis and institute appropriate treatment. In thissetting, vocabulary can be modified, as can the levelof assertiveness and the depth of questioning to suitthe needs of the individual. This flexibility is not readilyachievable with questionnaires which individuals mayalso find difficult to complete due their impersonalnature or because of physical or mental impairment,cultural or language differences. However, somepatients find the discussion of intimate issues withclinicians very difficult and questionnaires may allowthese issues to be measured in private, at ease andmore effectively before subsequently exploringquestionnaire responses in the clinical interview itself(Table 15).

1. RECOMMENDED QUESTIONNAIRES [GRADE A]

a) Golombok-Rust Inventory of Sexual Satis-faction

The Golombok-Rust Inventory of Sexual Satisfaction(GRISS), is a self-report inventory which has 56 items,from them 28 are for males and 28 are for females andit takes approximately 15 minutes to complete [203].The questionnaire was developed systematically bysex therapists at the Maudsley Hospital SexualDysfunction Clinic. The GRISS assesses the quality

IX. QUESTIONNAIRES TO ASSESSSEXUAL FUNCTION/SEXUAL

HEALTH AND URINARY SYMPTOMS

Table 15. Recommended questionnaires for theevaluation of sexual function and health in patientswith urinary symptoms

Grade A

Men and women Golombok-Rust Inventory of Sexual Satisfaction [203]

Men *ICIQ-MLUTSsex(ICSmale [27]) See section on ICIQ

International Index of Erectile Function [204]

ICSsex [205]

BPHQOL9 [118]

Women *ICIQ-FLUTSsex (BFLUTS [23]) See section on ICIQ

*Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ)

Grade B

Men and women Psychosocial Adjustment to Illness Scale [206]

Women Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire [207]

Brief Index of Sexual Function for Women [208]

The Female Sexual Function Index (FSFI) [209]

SQOL-F [210]

Men Brief Sexual Function Inventory [211]

Grade C (with potential)

Men and women Derogatis Interview for Sexual Functioning [206]

Sexual Behaviour Inventory [212]

Changes in Sexual Functioning Questionnaire [213]

Sexual Interaction Inventory [214]

Index of Sexual Satisfaction [215]

Multidimensional Sexuality Questionnaire [216]

Women McCoy Female Sexuality Questionnaire [217, 225]

BFLUTSsex [23]

Female Sexual Function ndex [209]

Sexual Function Questionnaire [218]

Simple Sexual Function Questionnaire [219]

Men DAN-PSSsex [220]

Sexual life quality questionnaire [221]

* Grade A new

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of a sexual relationship in a heterosexual couple andan individual’s functioning within it. This questionnaireis designed for people who are currently in arelationship. There are 12 domain scores, 5 of whichare female specific, 5 male specific and 2 non-genderspecific. The 5 female specific domains are:Anorgasmia, Vaginismus, Avoidance, Nonsexualityand Dissatisfaction. The 2 non-gender specificdomains are: Frequency of sexual contact and Non-communication. The questionnaire was validated ona clinical sample recruited from sexual dysfunctionclinics throughout the UK, consisting of 68 men and63 women, and a control group of 29 men and 30women randomly selected from primary careattendees. Split half reliability was 0.94 for the femalescale and 0.87 for the male overall scale. Averageinternal consistency of subscales was 0.74.

Both the overall female and male scores were foundto discriminate well between clinical and non-clinicalsamples and scores on subscales successfullydiscriminated specific diagnostic groups. There wasalso a significant correlation between therapists’ ratingsof severity and scores on the questionnaire.Responsiveness was assessed by comparing changein the questionnaire scores with rated improvementsby sex therapists. Correlations were moderate butstatistically significant (0.54 for males and 0.43 forfemales, p<.005 and p<.01 respectively). Test-retestreliability was assessed in 41 couples receiving eithermarital or sex therapy. A further two subscales applyto both males and females and cover infrequencyand non-communication. An additional 2 items eachfor males and females contribute to the overall scoresbut are not included in the subscales. The GRISShas been used by Hunt & Moss (1996) in a smallstudy exploring the relationship of unwanted sexualexperience to detrusor instability and sexualdysfunction [222]. High levels of sexual dysfunctionwere found in incontinent subjects compared to otherclinical groups. The GRISS is not applicable tohomosexual couples or people without a partner, butdoes provide an otherwise comprehensive, effectiveand well-used questionnaire.

b) ICIQ-MLUTSsex (ICSsex)

This forms one of the modules of the ICIQ modularquestionnaire (see above) [205]. It consists of 4 items:to what extent sex life has been spoilt by urinarysymptoms, ability to have erections, ability to ejaculate,and pain or discomfort on ejaculation. As with theother ICS questionnaires each item has an additionalpart to each item concerning the amount of bother thesymptom causes i.e. how much of a problem is thisfor you? It has been used in both clinic and communitysamples to assess the relationship between urinarysymptoms and sexual function, [205] and to showthat urinary symptoms most frequently associatedwith sexual dysfunction were those related toincontinence [223]. It has also been used in a

randomised trial of treatments for LUTS to investigatesexual side effects [224]. Aspects of reliability, validityand responsiveness have been tested and found tobe satisfactory.

c) International Index of Erectile Function (IIEF)

The international index of erectile function (IIEF) is a15-item self-administered questionnaire. It wasdesigned to assess erectile function and is culturallyand linguistically validated in at least 10 languages foruse in multinational clinical trials.213 It was initiallyvalidated in 351 patients with erectile dysfunction(ED) and found to have a high degree of internalconsistence (Crohnbach’s alpha > 0.85) and sensitivityto change with treatment. The questionnaire wasculturally and linguistically validated in the followinglanguages: Danish, Dutch, English (American,Australian and British), Finnish, French, German,Italian, Norwegian, Spanish and Swedish. The final 15-item instrument addresses five different domains ofsexual function: erectile function, orgasmic function,sexual desire, intercourse satisfaction and overallsatisfaction. The IIEF has a high degree of internalconsistence. Test-retest repeatability was high for thedomains of erectile function and intercoursesatisfaction and moderately high for the other domains.Discriminant validity was good for most domains(except the sexual desire domain). Construct validitywas good and all five domains showed a high degreeof sensitivity to change. An abridged 5-item versionof the questionnaire has also been developed (IIEF-5) [225]. Of the 5 items, 4 are from the erectile functiondomain and one addresses sexual intercoursesatisfaction. The main difference between the 5- andthe 15-item version is that the former asks patients toself-assess erectile function and satisfaction over thepast 6 months while the latter refers to a time frameof 4 weeks. It has been used recently in a multinationalsurvey of male ageing [220].

d) BPH QOL9

The QOL9 is a short form of the QOL20, a question-naire previously validated in French for men withLUTS related to BPH [118]. The short form wasdeveloped using a large-scale cohort study of 7093men with BPH who received alfuzosin for 3 months.The items were reduced by identifying questions thatcontributed most to establishing the global score andthat reflected the structure of the questionnaire onprincipal components analysis. The final, 9-itemquestionnaire consists of 3 items concerning generalwell being, 3 items assessing BPH interferences withactivities, and 3 items pertaining to patients’perceptions of their sexual life. The sexual functiondomain covered sexual desire, erectile function andsatisfaction with sex life. The QOL9 was validated intwo studies, a longitudinal study of alfuzosin, havinga sample size of 4259, and a smaller cross-sectionalstudy of men having symptomatic BPH (n=48), or no

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symptoms of BPH (n=42), and a group of youngermen (n=23). Feasibility and acceptability of thequestionnaire were assessed by completion ratesthat exceeded 85%. Principal components analysisconfirmed the three-factor structure. Discriminantvalidity was measured by comparing cases and non-cases. On the sexual function domain cases scored10.5, non-cases 15.2 and young men 26.3. The moststrongly discriminating question between cases andnon-cases was satisfaction with sex life. There wasalso a good correlation between symptom severityand the total QOL9 score. Internal consistency of theoverall scale was fair with Cronbachs alpha of 0.79for patients with BPH and 0.85 for the control groups.Test-retest reliability was good for the total score butmoderate for the sexual function subscale (ICC =0.69 - 0.88) with the reliability of the erection itemhaving an ICC of 0.53. After treatment the effect sizeof the change in the sexual function domain was linkedto age and initial symptoms severity but had a meanof 0.02 and 0.55 for patients treated in each of the twostudies.

e) ICIQ-FLUTSsex (BFLUTSsex)

This forms one of the modules of the ICIQ modularquestionnaire (see above) The questionnaire contains4 questions related to sexual function: pain ordiscomfort due to dry vagina, whether sex life hasbeen spoilt by urinary symptoms, pain on sexualintercourse, and leakage on intercourse [23]. Inaddition to each of these items the respondent isasked how much of a problem this is for them. It hasbeen used to assess sexual function after hormonereplacement therapy [226] and pelvic floor muscletraining [40]. There are 18 linguistic translationsavailable and there is published evidence of validity,reliability and sensitivity to change..

f) Pelvic Organ Prolapse/Urinary IncontinenceSexual Questionnaire (PISQ)

Rogers and colleagues in the United States havereported the development and validation of a measureof sexual function in women with urinary incontinenceor pelvic organ prolapse [207]. The scale consists of31 items spread across 3 domains: behavioural/emotive, physical, and partner-related. The measurehas been found to have acceptable convergent anddivergent validity and to be able to discriminatebetween women with and without urinary incontinenceor pelvic organ prolapse [207, 227]. Test-retest rangedfrom 0.56 to 0.93, showing some variability in themoderate to high reliability ranges [228]. The internalconsistency of the total measure and thebehavioural/emotive, physical and partner-relateddomains was .85, .86, .77, and .43, respectively [228].Sensitivity of the PISQ-31 has now been assessed inseveral studies.

A short form version of the questionnaire PISQ-12

has also been developed by the same team ofresearchers [229]. All subsets regression analyseswith r > 0.92 identified 12 items, across all threedomains, that were the most highly predictive of thePISQ-31 scores. Construct validity of the PISQ-12was examined through correlations with the long formof the questionnaire PISQ-31 (r=0.75-0.95), the SexualHistory Form -12, and the IIQ-7. Correlations of thePISQ-12 with these latter measures were similar tothose found for the PISQ-31.

The PISQ-12 scores were lower in those patients withpoorer sexual functioning and more depressivesymptoms. Test-retest reliability was moderate to high.Internal consistency reliability was stated as havingbeen done, although the values were not reported inthe article. Sensitivity of the PISQ-12 was notassessed.

An initial validation of a Spanish version of the PISQ-31 was reported for 34 bilingual patients of Mexican,Central or South American, Puerto Rican and Cubanorigins living in the United States [230]. Goodagreement between the Spanish and English versionswas achieved for 30 of the 31 items. The three-factorstructure of the original measure was validated in thissample of participants [227, 231-239].

2. RECOMMENDED QUESTIONNAIRES [GRADE B]

a) The Female Sexual Function Index (FSFI)

The Female Sexual Function Index (FSFI) [209] is a19-item self-report questionnaire for measuring femalesexual function and takes approximately fifteenminutes to complete. It provides five domains of sexualfunction, which have been confirmed using factoranalysis they include: Desire, Lubrication, Orgasm,Arousal, Pain and Satisfaction. An overall total scoreis also provided. The FSFI was developed using asample of 131 female controls (between the age of21-68) and 128 females who met Diagnostic andStatistical Manual of Mental Disorders (DSM-IV;American Psychiatric Association, 1994) criteria forFemale Arousal Disorder (FSAD). The age of theparticipants was matched [21-69]. Norms are availablefor both groups (controls and FSAD) at the individualitems level, the domains level, and the full-scalescores.

The FSFI discriminated reliably between women witharousal disorder (FSAD) and a control group on eachof the domains of sexual function as well as on thefull-scale score. FSFI data were also compared withresults from the Locke-Wallace Marital Adjustmenttest (1959), Correlations between the two weregenerally modest in magnitude, with the strongestobserved for the satisfaction domain of the FSFI.Internal consistency and test-retest reliability of theFSFI have been established. Test retest reliability ofthe scale was assessed in women with multiple

398

sclerosis with associated urinary and sexual symptoms[240].

Further cross validation studies were carried out todevelop cut-off scores for potential classification offemale sexual dysfunction [241, 242].

The FSFI was used in a study to investigate theprevalence of sexual dysfunction in women withchronic pelvic pain and with the [243] Female sexualdistress score (FSDS) to investigate sexual outcomesin women with LUTS who were successfully treatedwith sacral neuromodulation. A 60% increase in theFSFI overall score or 50% increase in FSDS score wasregarded as significant improvement [244]. The FSFIhas been used in a study of pelvic floor muscle trainingfor women with pelvic floor disorders and a study ofsexual function in women with symptomatic pelvicorgan prolapse who were treated with pessaries [233,245].

The Italian version of the FSFI has been used as ascreening tool for sexual dysfunction in healthy womenattending annual gynaecological health checks [246]The impact of LUTS and urinary incontinence onfemale sexual dysfunction was investigated over a 3year period in women undergoing urodynamic studiesusing the FSFI [247]. The Malay translation has alsobeen validated [248].

b) The Psychosocial Adjustment to Illness Scale(PAIS)

The Psychosocial Adjustment to Illness Scale (PAIS)was designed to assess the psychological and socialadjustment of male and female medical patients to theirillness and is in an interview or self-report format(PAIS and PAIS-SR) [206]. It contains a sexualrelationships domain consisting of 6 items assessingthe quality of interpersonal sexual relationships, sexualinterest, frequency of sexual activity, sexualsatisfaction, sexual dysfunction and interpersonalsexual conflict. Validation was carried out on groupsof patients having renal dialysis, lung cancer, cardiacproblems, breast cancer, and Hodgkin’s disease.Internal consistency of the sexual relationships domainranged from 0.8 to 0.93 in these different clinicalgroups. Factor analysis confirmed the subscalestructure. All 6 items in the sexual relationships domainhad very marked loadings on this dimension, with noappreciable loadings from other items. Convergentvalidity was assessed by comparing the scale to theGlobal Adjustment To Illness Scale (r-0.46), the SCL-90R (r=0.13), Affect Balance Scale (r=0.42), and thePatients Attitudes, Information and Expectancies Scale(r=0.40). Discriminant validity was assessed bycomparing patients screened positive and negative forlung cancer. There were differences in the meanscores between the two groups which approachedsignificance (t=1.53, p<0.10) [206]. 14 The PAIS hasbeen used to investigate the impact of different types

of urinary incontinence on sexual function [249] in asample of 200 patients referred for urodynamicassessment. Compared to patients with Urodynamicstress incontinence USI, patients having detrusoroveractivity DO were significantly impaired on all itemsof the sexual relationships subscale, apart from the‘sexual satisfaction’ item. Some aspects of validationwere also carried out in a small study of 29 patientswho had been treated successfully for penile cancer[250]. Internal consistency of the sexual relationshipsscales was good having Cronbach alpha of 0.83.Convergent and discriminant validity was shown insignificant correlations with well-being scales but notwith social scales. In addition, patients who had hadthe most radical treatments in terms of partial or totalpenectomy scored lower on the sexual relationshipsscale as did older patients (mean age 63 years)compared to younger patients (mean age 41 years),whereas having a mental disorder showed nocorrelation with sexual relationship scores.

c) The Brief Index of Sexual Function for Women(BISF-W)

The Brief Index of Sexual Function for Women (BISF-W) is a 22-item self-completed questionnaire thattakes 15-20 minutes to complete [208] It is designedto assess current levels of female sexual function andsatisfaction. It was originally validated in a sample of269 sexually active women age 20-73, and used a 3-factor scoring system (Interest/desire, Sexual activity,Sexual satisfaction) with acceptable test-retestreliability. A new quantitative scoring algorithm wasdeveloped to facilitate the use of the BISF-W in clinicaltrials, providing an overall composite score for sexualfunction and 7 domain scores; Thought/desire, Arousal,Frequency of sexual activity, Receptivity/initiation,Relationship satisfaction, Pleasure/orgasm, andProblems affecting sexual function. Norms for thecomposite score and for each of the seven dimensionscores are available, derived from a sample of 225healthy women (age 20-55) [251]. Comparing thesescores with those of 104 surgically menopausal,sexually active women who reported impaired sexualfunction (age 20-55), the instrument showed gooddiscriminant validity between women with and withoutsexual complaints in each of the 7 sexuality domains.In a placebo-controlled study, the BISF-W wassensitive to detecting differences between treatmentgroups in two of the 7 sexuality domains and on theoverall composite BSIF-W score.

d) Brief Sexual Function Inventory

This 22-item questionnaire concerning male sexualfunction was designed for clinical and researchpurposes in urological settings [211]. Items weregenerated from the literature to produce a 50-itemquestionnaire which was then reduced down to 22items in a series of pilot studies prior to the finalvalidation study. The questionnaire comprises of 5

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subscales: Libido, Erectile function, Ejaculation,Assessment of significance of each domain andOverall satisfaction. Validation was carried out on asample of 74 men with sexual dysfunction and 60general medical patients. Mean age was 55 and 45years respectively. The study describes developmentof individual subscales down to a final questionnaireof 11 items based on measures of internal consistencyand test-retest reliability. Internal consistency of thesubscales ranged from 0.62 to 0.95 and ICC’s from0.79 to 0.89 for test-retest reliability.

All subscales except the drive and ejaculationsubscales discriminated between patients beingtreated for sexual dysfunction and general medicalpatients, but it was not expected that drive would bereduced in patients experiencing sexual dysfunctionand ejaculation did not appear to be an importantissue for patients.

e) Sexual quality of life-female questionnaire(SQOL-F)

This questionnaire was developed to assess theimpact of sexual dysfunction on womens’ quality of life.Responsiveness to change has not been established[210]. The content validity of the SQOL-F, sexualfunction questionnaire (SFQ) and PISQ were furtherassessed in a postal study of women with OAB andurinary incontinence in the United States, and theSQOL-F was rated most relevant and understandableamong this group of women [252].

3. QUESTIONNAIRES WITH POTENTIAL[GRADE C]

Several questionnaires that have potential and arecurrently under development or in need of furtherdevelopment. With further validations these instrumentcould provide additional resources to research:

• The Derogatis Interview for Sexual Functioning(DISF) [206]

• Sexual Behaviour Inventory (SBI) [212, 223]

• The Changes in Sexual Functioning Questionnaire(CSFQ) [213]

• Index of Sexual Satisfaction (ISS) [215]

• Multidimensional Sexuality Questionnaire (MSQ)[216, 223].

• The Sexual Interaction Inventory (SII) [214]

• McCoy Female Sexuality Questionnaire (MFSQ)[217]

• Simple Sexual Function Questionnaire [219, 219,253]

• Sexual function questionnaire [218]

• DAN-PSSsex [220]

• Sexual life quality questionnaire (SLQQ) [221]

a) Other measures of sexual function

Many of the questionnaires assessing the psychosocialimpact of LUTS and/or UI contain one or two questionsrelated to sexual function. The majority of these arediscussed above, either as symptom questionnairesor general quality of life questionnaires. Questionnairescontaining just one question tend to focus on a generalassessment of the overall impact of urinary symptomson sexual functioning. The Kings Health questionnaire,[24] the Incontinence Impact Questionnaire [59] andthe I-QOL [75] are recommended by the Committeefor use for UI/LUTS. However, when considering thesexual items it must be borne in mind that validationof the sexual items was not always carried out ormade explicit. But the questions relating to sexualfunction in each of the questionnaires are very similarand judgements on validity can be made by comparingquestions and psychometric data between question-naires as well as considering the psychometricproperties of the scales as a whole. If more in-depthinformation is required concerning sexual function,the questionnaires recommended for this aspectshould be used (see above).

There are other general measures of sexual function,such as the Watts Sexual Function Questionnaire.[254] and Medical Outcomes Study (MOS) SexualFunctioning Scale [255]. There are also questionnairesthat have been designed for sexual dysfunction specificto particular diseases, such as Radiumhemmets Scaleof Sexual Function, [256] Sexual AdjustmentQuestionnaire (SAQ), [257] and Prostate-targetedHealth Related Quality of Life [258].

A small number of questionnaires have producedinitial validation but without publications during thereporting period: Effect of Urinary Incontinence onSexuality Questionnaire (EISQ), [259] and Effects ofurinary incontinence on sexual activity [260].

Most studies and questionnaires have been developedfor use with members of the general population orurology/gynaecology patients with incontinence orPOP. However, some specific patient groups mayexperience particular problems with incontinence (forexample, children, frail elderly or those who areseverely disabled), which may require independentinvestigation and potentially the development of morespecific measures or the addition of a new subset ofitems on already developed instruments. TheCommittee advises that researchers should useexisting highly recommended or recommendedquestionnaires if possible as this aids comparisonand to reduce the increasing proliferation ofquestionnaires. Many of the questionnaires developed

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below for particular conditions (e.g. prostate cancer)pre-dated the development of highly recommendedquestionnaires, and highly recommended question-naires should be used preferentially.

a) Older people

Urinary incontinence symptoms play an influentialrole on the overall HRQL in older people (>65) andcauses a significant decrease in HRQL, as severeas that of many chronic disease states. Since theelderly commonly have a number of associatedcomorbid conditions, it may be difficult to measurethe impact of urinary incontinence with generic HRQLmeasures. The use of incontinence specific tools tomeasure patient-reported outcomes in the elderly,therefore, is of considerable importance.

Validated incontinence-specific PRO questionnaires,such as IIQ, I-QOL or KHQ, are used for clinical trialsor research on urinary incontinence including elderlypeople, but their validity has not been specificallyassessed in this age group. Okamura, assessedsymptoms and HRQL in older people (men andwomen) with lower urinary tract symptoms includingincontinence, using the KHQ and IPSS. Theydemonstrated that symptoms and HRQL in the elderlywith LUTS could be assessed by IPSS and KHQ andthat urinary incontinence appeared to be moreassociated with a decreased HRQL in elderly women[80].

On the other hand, there are a variety of factorsaffecting older people, including physical, social,mental, economic or environmental conditions, whichare different from those of the young. In frail elderlypeople with dementia or physical impairment, it maybe difficult to assess the impact of urinary incontinencealone. Questionnaires specifically developed for theelderly may be of great importance in this respect.However, there is little relating to the development orvalidation of particular questionnaires for older peoplewith urinary incontinence. Two questionnaires dealingwith older people were found and are described below.No questionnaires dealing with patient outcomesspecifically for frail older incontinent people werefound.

1. THE URGE IMPACT SCALE (URIS) [GRADE B]

The Urge Impact Scale (URIS) was designed andtested specifically for older persons with urgencyincontinence. The URIS was developed and validatedby DuBeau et al. (1999) [261] and included 32 items,reduced to 24 items (URIS-24). The URIS-24 waspsychometrically assessed for validity and reliabilityin community-dwelling older (>65y) men and womenwith urge incontinence,. Cronbach alpha was 0.84for the URIS-32 and 0.94 for the URIS-24. Inassessment of test-retest reliability, interclasscoefficient (ICC) was 0.88. The URIS-24 had modestbut nearly significant correlation with the number of

urgency incontinence episodes (rho=-0.39, p=0.05).Factor analysis revealed 3 component structurescorresponding to physiological burden, perception ofpersonal control and self-concept. There was noanalysis for responsiveness. They showed that theURIS-24 is an internally consistent, highly reproducibletool for the assessment of the QOL impact of urgencyincontinence on older persons.

2. SWEDISH QUESTIONNAIRE [GRADE C]

A questionnaire survey was conducted among menand women aged over 75 years in Sweden [262]. Thequestionnaire was developed specifically for the studyalthough many questions had been used in a previousepidemiological survey [263]. The questionnaireachieved an admirable 62% response rate, but nodetails were published describing the psychometricproperties of the questionnaire or the method of itsconstruction.

There still remains a gap in the assessment of PROsfor frail older adults by other than subjective means.Many of the commonly used measures have beenused for older people as part of pharmaceuticalcompany studies but it is not known whether these arerelevant to the needs of the frail elderly or that theyrespond in a similar fashion when used in youngerpopulations.

b) Children

Some questionnaires have been developed specificallyto address issues for children, particularly enuresis.See Chapter (Children) and section on ICIQ modularquestionnaire.

c) Spinal cord injured/neurologically damaged

Individuals who have a spinal cord injury or areneurologically damaged can experience particulardifficulties with incontinence and the use of variousdevices. It would be useful to investigate whetherGrade A questionnaires, developed for people withoutneurological damage, can be used in this group, orwhether additional modules or instruments arerequired. This is an area where a small number ofquestionnaires are being developed with the Qualiveenbeing a notable exception (Also see section on theICIQ questionnaire and below).

QUALIVEEN: QUALITY OF LIFE RELATED TO URINARY

PROBLEMS IN SPINAL CORD INJURY [GRADE A]

The Qualiveen was developed to evaluate the specificimpact of urinary dysfunction on the quality of life ofspinal cord injury patients in France [264]. The initialitems were developed following patient interviews,and were then assessed for validity and reliability in281 spinal cord injury patients with urinary difficulties.The Qualiveen contains 30 items and has demons-trated good reliability and validity [264]. Furthervalidation of the Qualiveen has occurred in multiple

401

sclerosis patients [265] and it has been translatedand validated into English [266], German [267], andPortuguese [268]. The Qualiveen has demonstratedresponsiveness in multiple sclerosis patients and hasa suggested MID of 0.5 [269].

d) Prostate/bladder cancer

Many PRO questionnaires are available forassessment in this area: Post-radical prostatectomyquestionnaire, [270, 271] Cancer RehabilitationEvaluation System - Short Form (CARES-SF), [272]Prostate Cancer Treatment Outcome Questionnaire(PCTO-Q), [273] PROSQOLI, [274] ModifiedSouthwest Oncology Group (SWOG), [275] FunctionalAssessment of Cancer Therapy - (FACT-G), Bladderform (FACT-B) and Prostate form (FACT-P), [276]Functional Assessment of Cancer Therapy VandervietCystectomy Index (FACT-VCI), [277] EORTCmetastatic prostate cancer, [273] Changes in UrinaryFunction, [257] Prostate-targeted Health RelatedQuality of Life [258]. While it is beyond the scope ofthis chapter to review and recommend PROs in thisarea, the principles and guidelines discussed hereinapply to selecting a PRO related to prostate andbladder cancer.

e) Lower urinary tract symptoms/benignprostate disease

Many questionnaires have been developed to assessLUTS and benign prostate disease, however mostdo not contain a full evaluation of UI. Perhaps themost widely known urology PRO is the AUA SymptomIndex, [137] I-PSS (International Prostate SymptomScore) [137, 278].The IPSS has been utilitized interna-tionally to assess symptoms of prostate disease withdocumented reliability, validity and responsiveness.Additional PRO measures for BPH are as follows:Patient-completed modification of the Boyarsky [279]BPH Impact Index, [144] and BPH Health-related QoLsurvey [280].

The previous sections have provided an overview ofPRO measures with evidence of reliability, validity,and responsiveness. But, how does a researcherchoose which instruments are most appropriate for aparticular research study and/or clinical assessment?The following section provides general guidelines foruse in conducting PRO assessments in clinical trialsor other research investigations related to urinary orfaecal incontinence.

As there are many available PROs, it is of utmostimportance to select the PRO measure that is relevantand applicable to one’s desired outcome. If an

intervention is designed to reduce symptom bother,then a relevant PRO would be a symptom bothermeasure. Multiple PROs can be included in a researchstudy, however the designation of the PRO as aprimary or secondary endpoint must be . In addition,issues of staff and participant burden, time constraints,and resources should be considered in the selectionof a PRO measure.

1. SELECTING PRO MEASURES FOR RESEARCH STUDIES

a) Study Design

There are several protocol concerns that must betaken into account when using PRO measures inresearch studies, including the length of the study,the frequency of contact with the study participants,the timing of clinical assessments, the complexity ofthe trial design, the number of participants enrolled,and participant and staff burden. The goal of the PROinvestigation is to "fit" the PRO measures to theprotocol without compromising either the studyobjective or design. For example, if the study designis complex with frequent participant contacts andmultiple clinical measures, it may be necessary tokeep the PRO measures at a minimum or to reducethe number of times the PRO is assessed (e.g.baseline and end of study rather than during allparticipant contacts) to minimise participant and staffburden.

At the same time, however, PROs must be viewed asan important variable in the overall trial design andcannot be devalued in the data collection process.Consequently, PRO measures cannot be altered orreduced to accommodate study design as suchalterations may yield potentially less reliable measuresor may seriously diminish the integrity of the overallstudy design and yield useless information. Having welldeveloped research goals and questions regardingPROs will help to guide you in the selection ofmeasures for a study. The goal is to develop aconceptually adequate, yet practical PRO batterygiven the study population, the specific intervention,and the study design.

The frequency with which PRO will need to beassessed in a research study will depend upon thenature of the condition or intervention beinginvestigated and the expected effects (both positiveand negative) of treatment. At a minimum, as with allmeasurements collected in a research study, abaseline and end of study assessment should becompleted. In addition, other PRO assessments shouldbe timed to match expected changes in functioningdue to either the intervention or the condition or thedisease itself. Timing follow-up assessments tocoincide with typical patient follow-up visits, ifappropriate, may also reduce the costs involved infollow-up PRO and symptom assessments.

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b) Study Population

It is crucial to specify key population demographicsthat could influence the choice of instruments, therelevant dimensions of PRO to be assessed, and themode of administration. Thus, age range, gender,educational level, the language(s) spoken, and culturaldiversity should be carefully considered prior toselecting PRO measures. For example, a cohort ofpatients over the age of 70 may have more visionproblems than middle-aged persons, making self-administered questionnaires potentially inadvisable.Ethnically diverse groups also require measures thathave been validated across different cultures and/orlanguages.

In clinical trials, it is also as important to consider howthe disease or condition will progress and affect theoutcomes of patients in the control group as it is tounderstand the effects of the study treatment. Forexample, in patients with incontinence assigned to aplacebo-control arm of a study, one might expect asymptom to worsen and thus have an effect on dailyfunctioning. The point is to select PRO measures thatare sufficiently sensitive to detect changes in boththe treated and the control group patients. Use of thesame measures for both groups will ensure anunbiased and comparable assessment.

c) Intervention

There are three major factors related to the interventionthat are relevant to PRO assessment, and thereforerequire careful consideration: 1) the positive andadverse effects of treatment; 2) the time course ofthe effects; and 3) the possible synergism of thetreatment with existing medications and conditions. Itis crucial to understand how a proposed treatmentcan affect patient outcomes in both positive andnegative ways. For example, some drug therapiesmay relieve LUTS but produce side effects like drymouth or sexual dysfunction.

In addition, the time course of an intervention's effectson PROs is also critical both in terms of the selectionof measures and the timing of when PRO measuresare administered to study participants. For example,in a trial comparing coronary artery bypass graft(CABG) surgery to angioplasty, an assessment ofPRO one week post-intervention might lead to aninterpretation that the surgical arm was more negativethan angioplasty for PRO since the individuals in thisarm of the trial would still be suffering the effects ofthe surgical procedure (for instance, sore musclesand surgical site discomfort) which could overwhelmany benefits associated with CABG. However, at sixmonths post-intervention, the benefits of CABG surgerysuch as, relief from angina, might be more profoundthan the benefits received from angioplasty. Thus,when PRO is assessed could influence how oneinterprets the benefits (or negative effects) of theinterventions.

Finally, it is important to have a clear understandingof the current medications the patient population islikely to be taking prior to randomisation to the studytreatment, and how these medications might interactwith the trial intervention, (either a pharmacologicalor behavioural intervention), to influence patientoutcomes.

There are two types of PRO measures: generic andcondition-specific. Generic measures are designedto assess outcomes in a broad range of populations(e.g., both healthy as well as ill individuals). Theseinstruments are generally multidimensional, andassess at least the physical, social and emotionaldimensions of life. An example of this type of instrumentis the Medical Outcomes Study SF-36 Health StatusProfile. [281]. A second type of measure is condition-specific (e.g., instruments designed to assess theimpact of specific diseases, conditions, age groups,or ethnic groups). Condition-specific measures can besimilar to generic instruments in that they assessmultiple outcome dimensions, but condition-specificmeaures also include items more specific to theparticular condition or population being studied.Examples of frequently used condition specificinstruments include the Incontinence ImpactQuestionnaire, the King’s Health Questionnaire, andthe OAB-q (described above).

In general, the growing trend has been to includecondition-specific outcome measures in clinical trialsdue to their enhanced sensitivity to change and theneed to minimise participant burden. Importantly, thetype of instruments selected for inclusion in a researchstudy will depend on the goals of the intervention andthe specific research questions to be addressed. Inpractice, clinical trials that include PROs usuallyincorporate a combination of PRO measures mostrelevant to the study population and intervention, ifapplicable, being mindful of resource constraints andstaff and participant burden.

1. QUALITY-ADJUSTED LIFE YEAR (QALY)

Increasingly HRQL outcome measures are being usedin the development of quality-adjusted life year (QALY)measures. A QALY is a universal health outcomemeasure applicable to all individuals and all diseases,which combines gains or losses in both life quantity(mortality) and life quality (morbidity) and enablescomparisons across diseases and programs. QALYsare widely used for cost-utility analysis [282]. In thepast decades, economic evaluation has beenincreasingly important for the decision maker to decidewhich treatment or intervention is more cost-effective,in order to allocate limited healthcare resourcessoundly. Economic evaluation aims to compareinterventions in terms of their costs and benefits,

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including their patient outcome impact. Health benefitscan be quantified as QALYs (pronounced “qualies”),which has become a standard measure and is nowrecommended in most of health economics guidelinesas the method of choice [283]. The economic chaptercontains additional information regarding QALYs, asdo the following references: [284, 285].

2. SUMMARY

In summary, some general points to consider inselecting PRO measures for lower urinary tract andpelvic floor disorder studies:

• Ensure that the PRO research questions and studyendpoints are clearly defined. Determine the PROsthat are most crucial to assess and which are mostlikely to be affected by a particular condition and/orits treatment.

• Make good use of prior literature searches inidentifying past research in the area(s) of interest,as well as in identifying the types of PRO measuresother researchers have used in past work. Thisinformation can provide valuable information onhow particular outcome measures have performedin previous populations, as well as provideadditional information to assist in defining researchquestions/issues regarding the PRO componentsof any given study.

• Consider the characteristics of the population inselecting measures. For example, are the studysubjects to be children or older adults, well educatedvs. those with limited education, or persons withlow literacy? Ensure that the mode of data collectionis appropriate for use with the study population.Furthermore, do not assume that an instrumentvalidated for use with Caucasian, middle-classindividuals in the U.S. will be appropriate for usein other countries, and/or those of a lower socio-economic status or of different educationalbackgrounds. This chapter has indicated, wherepossible, the extent to which specific PROmeasures have been validated, and used reliablywith different populations.

• Use the questionnaires recommended in thischapter whenever possible. Do not “reinvent thewheel.” Developing new PROs is a time-consumingand complicated process. If a new scale needs tobe developed, ensure that the guidelines proposedby the FDA and EMEA on developing PROs arefollowed and that the appropriate expertise inquestionnaire development and psychometrics isavailable to your research team in order to guidethe questionnaire development process.

• Know the strengths and weaknesses of differenttypes of PRO measures. In general, genericmeasures are useful in providing information onmultiple patient outcome dimensions that can becompared across different populations. They may

lack sensitivity, however, in addressing concernsof specific patient populations (e.g., OAB, UI, faecalincontinence). Condition-specific instruments, incontrast, do address areas of function more specificto the condition, and tend to be more responsiveto changes in clinic status, due to their increasedspecificity in addressing the conditions of theirpatient populations. Weaknesses of condition-specific instruments, however, are that they areoften not appropriate for use with multiplepopulations, and cannot be used to make directcomparisons across different patient groups.

• Know how to score your selected PRO measuresand how to interpret the scores. Specifically, ensurethat the scoring method of a measure providesyou with the information you need to answer yourresearch question?

• Pilot testing of PRO measures with participants/patients similar to those in the target patientpopulation who will be assessed in a researchinvestigation is always advisable. Adjustments canthen be made in the protocol, if necessary, prior tothe initiation of the study.

• Finally, train and certify your staff to administerPRO measures using either patient interview and/orself-administration techniques, depending on themethod to be used in the study. The administrationprocess needs to be standardised and completelysimilarly across all participants.

The following recommendations were unanimous:

1. The selection of a PRO questionnaire must reflectstudy purpose and objectives

2. Grade A recommended questionnaires should beused in all clinical trials evaluating treatments

3. The inclusion of the ICIQ modules is preferredin all studies to standardise outcome assessment

4. Continued PRO development, refinement, anduse should accurately and adequately report onthe methods, samples, statistical analyses andpsychometric properties of questionnaires inscientific journals (i.e. validity, reliability andresponsiveness), so the quality of each studycan be assessed Researchers are encouragedto use existing questionnaires and refine forspecific populations when needed (e.g. frailelderly, children)

5. Researchers are encouranged to collaboratewith the ICIq project on the development andrefinement of modules and translations.

5B - F. RECOMMENDATIONS FORRESEARCH

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