Implants, Mechanical Devices, and Vascular Surgery for Erectile Dysfunction

Implants, Mechanical Devices, and Vascular Surgery forErectile Dysfunctionjsm_1626 501..523

Wayne J.G. Hellstrom, MD,* Drogo K. Montague, MD,† Ignacio Moncada, MD,‡ Culley Carson, MD,§

Suks Minhas, MD,¶ Geraldo Faria, MD,** and Sudhakar Krishnamurti, MD††

*Tulane University School of Medicine, Urology, New Orleans, LA, USA; †The Cleveland Clinic, Glickman Urological andKidney Institute, Cleveland, OH, USA; ‡Hospital La Zarzuela, Urology, Madrid, Spain; §University of North Carolina atChapel Hill, Urologic Surgery, Chapel Hill, NC, USA; ¶University College London Hospital, Uro-Andrology, UK;**Instituto de Urologia e Nefrologia de Rio Claro, Urology, São Paulo, Brazil; ††Andromeda Andrology Center,Hyderabad, India

DOI: 10.1111/j.1743-6109.2009.01626.x

A B S T R A C T

Introduction. The field of erectile dysfunction (ED) is evolving and there is a need for state-of-the-art informationin the area of treatment.Aim. To develop an evidence-based, state-of-the-art consensus report on the treatment of erectile dysfunction byimplants, mechanical devices, and vascular surgery.Methods. To provide state-of-the-art knowledge concerning treatment of erectile dysfunction by implant, mechani-cal device, and vascular surgery, representing the opinions of 7 experts from 5 countries developed in a consensusprocess over a 2-year period.Main Outcome Measure. Expert opinion was based on the grading of evidence-based medical literature, widespreadinternal committee discussion, public presentation, and debate.Results. The inflatable penile prosthesis (IPP) is indicated for the treatment of organic erectile dysfunction afterfailure or rejection of other treatment options. Comparisons between the IPP and other forms of ED therapygenerally reveal a higher satisfaction rate in men with ED who chose the prosthesis. Organic ED responds well tovacuum erection device (VED) therapy, especially among men with a suboptimal response to intracavernosalpharmacotherapy. After radical prostatectomy, VED therapy combined with phosphodiesterase type 5 therapyimproved sexual satisfaction in patients dissatisfied with VED alone. Penile revascularization surgery seems mostsuccessful in young men with absence of venous leakage and isolated stenosis of the internal pudendal arteryfollowing perineal or pelvic trauma. Currently, surgery to limit venous leakage is not recommended.Conclusions. It is important for the future of the field that patients be made aware of all treatment options forerectile dysfunction in order to make an informed decision. The treating physician should be aware of the patient’smedical and sexual history in helping to guide the decision. More research is needed in the area of revascularizationsurgery, in particular, venous outflow surgery. Hellstrom WJG, Montague DK, Moncada I, Carson C, MinhasS, Faria G, and Krishnamurti S. Implants, mechanical devices, and vascular surgery for erectile dysfunction.J Sex Med 2010;7:501–523.

Key Words. Surgical Treatment for Erectile Dysfunction (ED); Penile Prosthesis; Penile Implants; Penile ArterialRevascularization Surgery; Vacuum Erection Devices; Venous Ligation Surgery

Penile Implant Surgery

Introduction

A satisfactory erection has been the pursuit ofmankind for millennia. Historically, numer-

ous potions and superstitions have been used toimprove erectile function, often with a placebobenefit.

The introduction of penile prostheses for thetreatment of men suffering with erectile dysfunc-tion (ED) has opened new avenues of basicresearch, introduced the concept of related medicalcomorbidities, established an epidemiology for thiscondition, and stimulated a variety of successfulless-invasive treatment options. Indeed, recentadvances in the science and clinical management of

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sexual dysfunction can largely be attributed to theintroduction of the modern day penile prosthesis.

Early implants were wooden splints that sup-ported the penis in a semirigid state. The Frenchsurgeon Ambrose Pare suggested an “artificialpenis” made of a wood pipe constructed forpatients after traumatic penile amputation in orderto facilitate urination in the standing position.Although not intended for sexual intercourse, onemay refer to this 16th century device as an early“penile prosthesis.”

The first real implant using autologous materi-als was the use of rib cartilage in conjunction witha tubed phalloplasty by Russian surgeon Bogorazin 1936 [1]. Future endeavors by this far-sightedsurgeon utilized rib cartilage in morphologicallyintact penises in men suffering from ED. Unfor-tunately, long-term success with this method waslimited by natural resorption.

The use of alloplastic materials originates fromexperimental materials developed in otolaryngol-ogy laboratories and resulted in the first acrylicsubcutaneous penile implants in 1949 [2]. Anothermajor innovation was the intracavernosal implan-tation of acrylic rods by Egyptian surgeon G.E.Beheri [3]. After the clinical acceptance of mal-leable and semirigid implants, Scott et al. intro-duced the three-piece inflatable device in 1973 [4].Besides progress in the design and durability of thepenile implant, a whole industry focusing on EDdiagnosis and treatment has evolved. Diagnosticmeasurement devices became more sophisticated,but with time have largely been supplanted by morespecialized validated subjective questionnaires.

While the newer medical treatments are con-sidered first and second lines of therapy, penileimplants still remain a popular and importantoption for men with medication-resistant ED.Additionally, implants are appropriate whenmedical therapy is contraindicated, causes severeside effects, vacuum erection therapy has provenunsatisfactory or unacceptable, and/or in men withend organ failure (e.g., diabetes mellitus), severestructural abnormalities (e.g., Peyronie’s disease),or cavernosal fibrosis (e.g., after prolonged pri-apism or infection).

Indications for SurgeryPenile prostheses are indicated for the treatmentof organic erectile dysfunction in men who fail orreject more conservative measures, such as oralphosphodiesterase type 5 (PDE5) inhibitors,vacuum erection devices (VED), urethral alpros-tadil suppositories, and intracavernosal injection

therapy. For those men in whom penile prosthesesare suggested, careful counseling before penileimplant procedures will limit many of the prob-lems with postoperative dissatisfaction. Once thediscussion and demonstration of penile implantvarieties has been carried out, patients may thenchoose a specific prosthetic type based on theirneeds and preferences.

Types of Penile ImplantsThere are three classes of penile implants: hydrau-lic, semirigid, and soft silicone (Table 1) [1–3]. Thehydraulic consists of two types: the three-pieceinflatable and the two-piece inflatable. Twocompanies manufacture the three-piece variety:American Medical Systems (AMS) (Minnetonka,MN) and Coloplast (Minneapolis, MN).

Finally, there are soft silicone rods that wereoriginally manufactured in France by Subrini [4].Currently, these inexpensive devices are sold undervarious names in several countries, mostly inEurope and mainland China. This implant hasbeen promoted to aid the partially impotent manwho has tumescence, but not rigidity. The softsilicone implants are used less often because manyof these men with partial ED now respond to oralmedication. There are other rods manufacturedlocally throughout the world, but few of these findtheir way out of their native countries (Table 2).

Preoperative Preparation and Postoperative CareMost penile implants are placed in patients with anorganic etiology to ED, and have failed to respond,did not tolerate, or are unwilling to consider moreconservative options [5]. Oral therapy often fails in

Table 1 Available penile prostheses

Semirigid rods Inflatable

AMS 600/650 (AMS) 700 CX (AMS)Malleable (Coloplast) 700 LGX (AMS)Dura II (AMS) Alpha 1 (Coloplast)

Titan (Coloplast)Ambicor (AMS)

Table 2 Various semirigid penile protheses

Prosthesis name Country

Promedon Tube Prosthesis ArgentinaHR Penile Prosthesis BrazilSilimed Penile Prosthesis BrazilJonas (ESKA) Prosthesis GermanyShah Implant IndiaVirilis I and II Implants Italy

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men with severe ED due to diabetes mellitus orafter radical pelvic surgery. Men with severe Pey-ronie’s disease-associated ED, severe penile fibro-sis, or cases of post-priapism are more likely to beconsidered for implantation of a penile prosthesis.

Diabetes mellitus is known to be a risk factor forsevere ED and the need for penile prosthesisimplantation [6]. In 1992, Bishop et al. suggestedthat patients with diabetes mellitus whose bloodsugar was in better control for a period of timepreoperatively, as manifested by a normal hemo-globin A1C, were less prone to develop a penileimplant infection vs. a group whose Hgb A1C waselevated [7]. Other larger series repeated this studyand found no difference in infection rates inpatients with normal or elevated Hgb A1C [8].The presence of diabetes raises the risk of pros-thetic infection from 3% to 8%, but the level ofglycosylated hemoglobin, the fasting blood sugaron the day of surgery, and whether the patientwas insulin-dependent, were not predictive forincreased rate of infection [8]. Another study,however, showed no difference in infection ratesbetween diabetic and non-diabetic men receivingpenile prostheses [9].

Patients shower with antibacterial soap for a fewdays prior to surgery. Shaving of the genital area isperformed in the holding area or operating roomto minimize the chance of bacterial colonization.Antibiotics are initiated prophylactically 1 hourprior to surgery. The antibiotic choice is made bythe surgeon, and this decision should cover thepossibility of infection by skin contaminants.There have never been any controlled studies inpenile prosthesis recipients demonstrating thatpostoperative antibiotics decrease the incidence ofsurgical infections.

Pain following placement of a penile prosthesisis variable and individual. The pain is usually moreprolonged than genital procedures without pros-thetic components.

Some scrotal ecchymosis and swelling iscommon, and a scrotal hematoma, if it forms,usually slowly resolves without operative inter-vention.

Patients are instructed at discharge to wearbrief-type underwear for the first month and directtheir penis upward if possible. Coloplast implantswith a lockout valve prevent fluid transfer from thereservoir to the cylinders. A capsule has notformed around the reservoir fully until 3 monthspostoperatively, and in the early period in patientswithout a lockout valve, any increase in intrab-dominal pressure may cause fluid to leak from the

reservoir into the cylinders, causing partial tumes-cence. In such cases, the patient should eitherdeflate his device or return to the office for defla-tion. Generally, at 3 months, a capsule has formedaround the reservoir and protects the patient fromfuture auto-inflation. A new pump from AMS forthe three-piece prosthesis that prevents auto-inflation has been recently introduced into themarket.

Patients are taught how to operate theirhydraulic devices at approximately 4 to 6 weeks.Some surgeons prefer to begin the cycling ofdevices earlier, but in most patients, pain will be alimiting factor to early cycling. At 3 months, mostpatients are pain-free. In some cases (e.g., diabetesmellitus), neuropathic pain may persist for longerperiods of time. If prolonged pain does occur, thesurgeon should suspect the possibility of a sub-clinical infection associated with the prosthesis.

After patients are instructed in the operation oftheir device, they are advised to cycle regularly.When the cylinders are left semi-inflated for pro-longed periods of time, a capsule forms over thereservoir in the less-than-full state that therebyrestricts its expansion. Patients particularly dislikeauto-inflation if they are attempting to achievecomplete flaccidity. After 3 months, it is usuallyno longer possible to influence reservoir capacity,and corrective capsulotomy may be necessary tocorrect bothersome auto-inflation [10].

AnesthesiaThree-piece penile implants are placed undergeneral or regional anesthesia. A short actingspinal is ideal for the procedure. Local anesthesiais inadequate for reservoir placement. On theother hand, semirigid rods may be placed withlocal anesthesia only. A penile block with 1%lidocaine is utilized before a tourniquet is placedaround the base of the penis, and approximately25 cc of anesthetic is instilled into either corpuscavernosum and held in place for 1 minute. Thetourniquet is released, allowing the local anes-thetic to diffuse into the proximal portion of thecorpora. Infiltration of the skin incision site com-pletes the anesthetic block. Some surgeons injectthe corpora with a small amount of long-actinganesthetic such as marcaine to keep the patientpain-free in the immediate postoperative period.

Operative TechniqueSurgical implantation of penile prostheses can becarried out using a variety of surgical approachesand incisions. Semirigid and malleable prostheses

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can be implanted through a distal penile approach.Multiple-component prostheses, however, can beimplanted by the infrapubic or penoscrotalapproach. While individual surgeons have avariety of rationales for each of these approaches,there does not appear to be any clear advantagein patient satisfaction or outcome of the twoapproaches. There is no difference in infectionrates between either infrapubic or scrotal incisions[6]. Patient anatomy may dictate appropriatechoice. Patients with previous abdominal surgicalprocedures where reservoir placement is difficultmay be better served with an infrapubic approach,while patients with massive obesity may be betterapproached through a penoscrotal incision. Two-piece devices, because there is no separate reser-voir, are best implanted through a penoscrotalincision.

Penile Prosthesis ComplicationsInfectionPeriprosthetic infection—infection in the spacearound a penile prosthesis—is the bane of geni-tourinary prosthetic surgery. While men withthese infections are seldom seriously ill, eradica-tion of the infection invariably requires completedevice removal. Subsequent penile prosthesisreimplantation is difficult due to scarring of thecorporeal smooth muscle, which leads todecreased penile length and girth, as well as diffi-cult cylinder implantation.

The use of prophylactic broad spectrum antibi-otics is widespread in penile prosthetic surgery;however, the timing of the administration of theseantibiotics varies. Guidelines suggest that “infu-sion of the first antimicrobial dose should beginwithin 60 minutes before surgical incision and thatprophylactic antimicrobials should be discontin-ued within 24 hours after the end of surgery [11].”

Traditionally, infection rates in revision penileprosthetic have been higher than with primaryimplant surgery. When at the time of revisionsurgery the entire device is removed and theimplant spaces are lavaged with a series of antisep-tic solutions before implantation of a new device,the infection rate is similar to that with first time(primary) penile prosthesis implantation [12].Earlier, however, it had been shown that when theold implant is entirely removed and replaced witha new device, lavage with only one antibiotic solu-tion was enough to achieve an infection rateequivalent to that seen with primary penile pros-thesis implantation [9].

In 1996, Brant and Mulcahy introduced theconcept of penile prosthesis salvage for infectedimplants [13]. With this procedure, the entireinfected device is removed and the implant spacesare lavaged with a series of antiseptic solutions. Anew prosthesis is then implanted. This series wasupdated in 2000 [14], and again in 2003, at whichtime the success rate of salvage in a series of 101infected implants was 84% [15]. After inflatablepenile prosthesis implantation, infection usuallyfirst becomes evident by tissue changes around thepump. It is now generally accepted that the entirepenile prosthesis is infected. Whether a salvageprocedure is performed or the device is removedwith planned later reimplantation, it is mandatoryto remove all the prosthetic material including, ifpresent, polytetrafluoroethylene tubing coveringsand rear tip extenders (Table 3) [15].

Unfortunately, some surgeons still remove onlythe pump; with subsequent removal of the restof the device becoming necessary because ofinfection.

Superficial wound separation and/or infection ismore common than periprosthetic infection. If theentire penile prosthesis is implanted below thefascia, routine wound care will result in woundhealing without device infection. With inflatablepenile prostheses, where the pump and cylindersare often available as a unit, surgeons using a peno-scrotal approach often use a technique that resultsin tubing being present under the scrotal skin andsubcutaneous tissue. This is not only undesirablefrom a cosmetic standpoint, but it also greatlyincreases the chance of device infection should asuperficial wound infection or separation occur.Routing the pump through an opening in the backwall of the scrotal pouch for the pump buries thetubing beneath the fascia, thus avoiding theseproblems.

Table 3 Mulcahy Salvage Protocol [15]

StepsRemoval all prosthetic parts and foreign materialIrrigate wound and all compartments with 7 antiseptic solutionsChange gowns, gloves, drapes, and instrumentsImplant new prosthesisPrimary wound closure without drainsOral antibiotics as determined by culture for 1 month

7 Antiseptic solutionsKanamycin and bacitracinHalf strength hydrogen peroxideHalf strength povidone iodineWater pic pressure irrigation with 1 gm vancomycin and 80 mg

gentamicin in 5 LHalf strength povidone iodineHalf strength hydrogen peroxideKanamycin and bacitracin


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In 2001, AMS introduced a dual antibioticcoating, minocycline and rifampin, for their three-piece inflatable penile prosthesis product line.This was shown to decrease the infection rate 180days after implant from 1.61% to 0.68% [16].Mentor Corporation (now Coloplast) soon afterintroduced a hydrophilic coating, polyvinylpyr-rolidone (PVP), for their three-piece inflatablepenile prosthesis. This coating allows the implant-ing surgeon to immerse the device in an antibioticsolution of his or her choosing. This resulted in adecrease of the infection rate 1 year after implantfrom 2.07% to 1.06% [17].

Auto-InflationPartial spontaneous inflation of a three-pieceinflatable penile prosthesis sometimes occurs andmay be bothersome to the patient. In one study,the rates of auto-inflation in men implanted withthree-piece inflatable prostheses after prostatec-tomy was 3%, and in men with erectile dysfunc-tion due to other causes, it was 5% (P > 0.99) [18].Mentor introduced a lock-out valve in the reser-voir stem that resulted in a 1.3% rate of auto-inflation compared to an 11% rate in historicalcontrols [19]. AMS recently introduced a lock-outvalve at the top of the pump of their AMS700MS™ device; published rates of auto-inflationwith this prosthesis are not yet available.

Glans Problems after PenileProsthesis ImplantationPatients who are considering penile prosthesisimplantation should be told about the lack of glanstumescence and that their erection may be shorterthan their former natural erection. Some men whocomplain of lack of glans tumescence or coolnessafter penile prosthesis implantation may benefitfrom the use of a PDE5 inhibitor or from the useintraurethral alprostadil (MUSE, Vivus, MountainView, CA) [20].

Other patients may complain of poor support ofthe glans penis by the tips of the prosthesis. Thisdownward drooping of the distal penis is referredto as the SST deformity because of the similarityof its appearance to the supersonic transport orConcord aircraft. If the SST deformity is due tocylinders that are too short, revision with implan-tation of longer cylinders will correct the defor-mity and result in a somewhat longer penis.Sometimes this deformity occurs because of ana-tomic variations in the relationship of the glanspenis to the corporeal tips. In this case a glanu-lopexy modified after that originally described byBall [21] may be helpful [22].

Reservoir DisplacementIn three-piece inflatable penile prosthesis implan-tation by the penoscrotal approach, the empty res-ervoir is inserted blindly into the retropubic spaceby perforating the fascia on the medial side of theexternal inguinal ring or through the fascia justabove the pubic tubercle. This is safely done byinsuring complete bladder emptying through aurethral catheter. The fascial defect created shouldbe tight to the surgeon’s finger. Filling the reser-voir with saline after placement helps maintainits retropubic position. Reservoir displacementor herniation into the inguinal canal or upperscrotum will rarely occur. One survey found anincidence of this complication at 0.7% [23]. Cor-rection of this complication is by revision throughan inguinal incision with placement of the reser-voir in its proper position and repairing the defect.

Distal Cylinder Erosion or ExtrusionBecause of loss of sensation, erosion of a penileimplant into the urethra occurs more commonly inparaplegic or quadriplegic recipients. This erosionrate was 18.1% (15 of 83) cases of semirigid rods,2.4% (2 of 84) for self contained inflatable prosthe-ses, and 0% (0 of 28) for three-piece inflatabledevices [24]. Three-piece inflatable prosthesesappear to be associated with less risk of this com-plication in these recipients. Distal cylinder extru-sion laterally can be repaired by creating a newcavity for the distal cylinder behind the back wall ofthe fibrotic sheath containing it [25]. An alternativetechnique is to perform distal corporoplasty usingsynthetic material [26]. Proximal perforation of thecura during the implant procedure can be repairedby constructing a wind sock of vascular prostheticmaterial and anchoring this to the prosthesis [27].

However, perforation of the crus during dila-tion usually occurs with the use of narrow dilatorsand is recognized by the sudden passage of thedilator into the soft tissue of the perineum. Whenthis occurs, it is usually possible to use large scis-sors to establish the true plane of dilation down tothe attachment of the crus to the pelvic bone.

Larger dilators follow this plane, thus avoidingfurther dilation of the false passage. The rear tip ofthe cylinder can then be implanted within the crus.The small false passage heals over the tip of thecylinder. These steps eliminate the need for a windsock repair.

Carvernosal FibrosisSmooth muscle fibrosis occurs in men with EDfollowing prolonged ischemic priapism and in


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men who have had removal of an infected penileprosthesis.

Dilation of the corpora can be quite difficult,and limited dilation may be all that can beachieved. Smaller diameter penile prostheses areuseful in these cases. If primary closure of thetunica albuginea over the prosthesis is not pos-sible, the device may be covered by graft material.The following graft materials have been used forthis purpose: human cadaveric dura mater [28],polytetrafluorethylene [29], human cadaveric peri-cardium [30], and porcine small intestinal submu-cosa [31]. The results of prosthetic surgery usingnarrow diameter cylinders are often satisfactory.When they are not, future upsizing to wider andsometimes longer cylinders may be helpful [32].

In cases of severe cavernosal fibrosis, corporealexcavation through extended corporotomies hasbeen successfully performed with most of thefibrotic contents of the corpora being removed[33]. This leaves a tunica albuginea shell intowhich the prosthetic cylinders can be laid. Primaryclosure of the tunica albuginea over the cylinders isthen easily accomplished without graft materials.

Penile Prosthesis SurvivalMechanical failure of penile prosthesis can includeleakage from the cylinders, tubing fracture, reser-voir malfunction, connector disruption, tubekinking, and cylinder aneurysm. Failure ratesamong inflatable penile prostheses (IPP) have his-torically been low (Table 4). A recent study fromthe University of Arkansas assessed the long-termsurvival of IPP, covering both AMS and Mentor/Coloplast models (n = 2,384), and documented theoverall 15-year freedom from reoperation to beabout 60%, with no significant difference betweenmodels [40]. Another study evaluated the efficacyand survivability of the two-piece Ambicor inflat-able penile prosthesis, finding that due to recentrevisions in rear tip extenders and pump tubingreinforcement, freedom from reoperation was

99.2%, 99.2%, and 91% at 12, 36, and 48 months,respectively (n = 146). Corresponding patient andpartner satisfaction were 85% and 76%, respec-tively [41]. The AMS three-piece 700 CX wasevaluated for long-term survival in a recent studyincluding 455 patients and was found to have anoverall freedom from reoperation of 74.9% andfreedom from mechanical failure of 81.3% after 10years [42].

Patient and Partner SatisfactionNumerous studies have reported high satisfactionrates for both patients and partners after penileprosthesis implantation for the treatment of ED.In a series of 185 patients from a group of Euro-pean institutions, authors reported a 98% patientand a 96% partner satisfaction rate [43]. The rapidability to produce an erection and consistent excel-lent rigidity with the prosthesis were two majorfactors contributing to this high level of satisfac-tion for this modality of ED treatment. Lowersatisfaction rates have been noted when there is anoverall loss of penile length, such as in revisionsurgery after infection and in prosthesis implanta-tion for Peyronie’s disease with penile shortening[44,45].

Patient satisfaction is a complex and multi-factorial issue that may include the degree of post-operative pain and swelling, occurrence ofpostoperative complications, cosmetic outcome,device function, ease of use, and partner accep-tance. Besides the shorter length of the penileerection, other reasons given for dissatisfactioninclude reduced sensitivity, diminished sexualdrive, unnatural feeling by the partner, and thepartner perception of having a diminished role ininitiating erection. Another common patient com-plaint is the lack of glans engorgement duringsexual activity. Typically, the patient reports thatthe corpora cavernosa provide satisfactory rigidityafter activating the implant, but notes a soft andmobile glans. One recent study reported on the

Table 4 Failure rates of various inflatable penile prostheses by type and follow-up period

Follow-up (yrs)Kaplan-Meier (KM)or mean (M)

Mechanicalfailure Prosthesis type

Daitch [34] 5 (KM) 9.10% CX three-piece (AMS)17.10% Ultrex (pre 1993 modification)

Wilson [35] 5 (KM) 7.40% Alpha 1 (Mentor/Colopast)Ferguson [36] 5.7 (M) 0 Malleable –Duraphase (now AMS)Deuk Choi [37] 4 (M) 7.30% 700 CXM (AMS)Levine [38] 3.5 (M) 2.3% Ambicor 2-piece (AMS)Milbank [39] 5 (KM) 6.3% Ultrex post 1993 modification


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beneficial effect of sildenafil (Viagra, Pfizer, NewYork, NY) on glans engorgement in patientshaving undergone penile implant [46]. By usingthe International Index of Erectile Function(IIEF), researchers documented that sildenafilcaused a statistically significant improvement inimplant-assisted intercourse. Similar results werereported with the on demand administration oftransurethral alprostadil in patients with self-contained inflatable penile prostheses [47].

Research evaluating the efficacy and satisfactionof prosthesis implantation continues (Table 5). In arecent study of 146 recipients of two-piece penileprostheses, the authors reported 85% satisfactionamong the men and 76% satisfaction among theirpartners [41]. Even more impressive are the datafrom a large Italian study, which showed patientsatisfaction of 97%, 81%, and 75% with the AMS700CX, AMS Ambicor, and AMS 600–650;partner satisfaction was 92%, 91% and 75%,respectively [48]. A recent case series from Chinareported successful coitus in 97.6% (41 of 42) ofpatients after IPP placement, which was higherthan previous reports [49].

Certain patient factors may be predictors ofreduced satisfaction. In an Italian multi-institutionstudy surveying patients with penile implants andPeyronie’s disease, 79% of patients and 75% ofpartners reported satisfaction with the result [43]. Itis recognized that patients with Peyronie’s disease,radical prostatectomy, or a BMI > 30 kg/m2 have astatistically significant reduction in level of satisfac-tion compared with the general implant population[50]. It is likely that penile length issues play a largerole in Peyronie’s disease and radical prostatectomypatients in this regard. It has not been clearlydelineated why a BMI > 30 kg/m2 should be asso-ciated with reduced satisfaction, but mechanicalissues relating to the pre-pubic fat pad size havebeen noted in many of these men.

Efficacy can also be assessed in a more quanti-tative fashion with postoperative IIEF scores. Onegroup reported IIEF scores 3, 6, and 12 monthsafter placement of a Mentor/Coloplast Alpha-1

IPP. They found IIEF erectile function domain(EFD) scores to be 13, 21, and 24 and IIEF Satis-faction scores to be 9, 11, and 15 at each respectivetime interval (baseline in both groups = 7) [51]. Arecent study assessing patient overall satisfactionwith a specialized questionnaire reported patientsatisfaction to be 69%, which is in general agree-ment with prior reports using other questionnaires[52].

Earlier studies compared inflatable and semi-rigid prostheses and found increased satisfaction inmen using inflatable devices over noninflatablepenile prostheses. Another study showed a corre-sponding higher satisfaction among female part-ners of men using inflatable protheses incomparison to noninflatable prostheses [53]. Asexpected, satisfaction domain scores for patientswith corporal fibrosis and shortened peniseswho had undergone revision prosthesis surgeryreported lower scores compared to other revisionimplant groups [54]. In a recent study comparingMentor/Coloplast Alpha prostheses to the AMSseries, no difference in satisfaction rates was foundbetween the two models when employing a spe-cialized follow-up questionnaire [52].

Comparisons between IPP and other forms ofED therapy generally reveal a higher satisfactionrate in men with ED who chose the prosthesis. A2003 study using IIEF EFD and Erectile Dysfunc-tion Inventory for Treatment Satisfaction scoringsystems comparing IPP, intracavernous prostag-landin E1 injections (ICI), and sildenafil showedthat IPP had significantly higher satisfaction ratescompared to the other ED treatment modalities[55].

RecommendationsIndications for Penile Prosthesis Implantation• Penile prosthesis implantation is indicated for

the treatment of organic erectile dysfunctionafter failure or rejection of other treatmentoptions. Level of Evidence 3, strength of rec-ommendation C

Table 5 Recent publications of IPP satisfaction data

Author Year Satisfaction Comment

Natali et al. [48] 2008 97%/81%/75% AMS 700CX/Ambicor/600-650Xuan et al. [49] 2007 97.6% Percent achieving coitusLux et al. [41] 2007 85% Ambicor modified two-pieceKava et al. [54] 2007 77% Only post-revision patients evaluatedAkin-Olugbade et al. [50] 2006 60–86% (15 out of 20) RP, obesity, and PD were negative predictors of satisfactionMulhall et al. [51] 2003 IIEF 15 at one year (baseline 7 out of 20) IIEF satisfaction domain at 1 year doubled from baseline


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• The three-piece inflatable penile prosthesis isrecommended for younger patients with normalmanual dexterity, patients who wear form fittingclothes, or patients that shower in public. Levelof Evidence 3, strength of recommendation C

• Inflatable penile prostheses are recommendedfor patients with Peyronie’s disease, as a second-ary implantation, or patients with neurologicaldisease. Level of Evidence 3, strength of recom-mendation C

• Malleable prostheses are recommended forsignificantly obese patients, and those withminimal manual dexterity, or when the cost ofinflatable penile prostheses is prohibitive. Levelof Evidence 3, strength of recommendation C

Preoperative Preparation and Postoperative CareIn order to prevent complications, it is importantto obtain the patient’s medical and sexual historyand perform a physical examination before theprosthesis is implanted. The physician shouldensure the patient is aware of all other treatmentoptions and get an accurate idea of what thepatient hopes to achieve. This will help in choos-ing the appropriate prosthesis for the patient.Level of Evidence 3, strength of recommendationC.

Postoperative CarePatients are recommended to follow-up withdoctors to learn how to use their devices optimally,ensure their devices are working properly, andconfirm there are no postoperative complicationssuch as infection, fluid leaks, or autoinflation.Level of Evidence 3, strength of recommendationC.

Informed ConsentThe patient should be informed of the followingpossible complications related to the prothesisprior to implantation: infection and its conse-quences, pain, mechanical failure, penile shorten-ing, autoinflation, and libido, orgasm, andejaculation issues. Level of Evidence 3, strength ofrecommendation C.

AnesthesiaInflatable and semirigid rods are usually implantedunder regional or general anesthesia. Rarely, localanesthesia can be used for malleable types of pros-theses. Level of Evidence 3, strength of recom-mendation C.

Operative TechniqueDistal penile, infrapubic, and penoscrotal are thethree main approaches for inserting the penile

prosthesis. The method chosen is based upon theprosthesis type, patient’s specific anatomy, surgicalhistory, and surgeon preference. Level of Evidence3, strength of recommendation C.

Penile Prosthesis ComplicationsA. Infection:• Periprosthetic infection is an important concern

for both doctors and patients, not only becauseit can cause serious illness, but also requiresthe complete removal of the devices. Subse-quent reimplantation is difficult because of scarformation.

• Level of Evidence 3, strength of recommenda-tion C.

• A number of measures have been taken todecrease the risk of infection. Still, there is noconsensus on a standardized method of mini-mizing infection rates. AMS and Coloplast,both manufacturers of hydraulic implants, havetaken steps to decrease infection rates by apply-ing antibiotic coatings or hydrophilic surfaces totheir prosthetic devices. Initial research suggeststhese newer interventions decreases the rate ofprosthetic infection.


• In addition to using an antibiotic coating on theprosthesis, prophylactic broad spectrum antibi-otics have also been used with guidelines sug-gesting application within 60 minutes beforesurgical incision. Also, antimicrobials should bediscontinued within 24 hours after the end ofthe surgery.


• If the prosthesis becomes infected, it is recom-mended the entire prosthesis should beremoved. In certain situations a salvage proce-dure may be performed in which the entire areais lavaged with a variety of solutions and a newdevice is implanted.


B. Other complicationsSpontaneous inflation is a potential and bother-

some problem with the three-piece inflatablepenile prosthesis. Additionally, lack of full glanstumescence, shorter erections, unwanted move-ment of the pump or reservoir, erosion into theurethra, fibrosis, and mechanical failure are otherpotential complications associated with penile


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prostheses. Level of evidence 3, strength of rec-ommendation C.

Penile Prosthesis Survival• Many studies have been conducted regarding

long-term survival of inflatable penile prosthe-ses, with failure rates of both the two-piece andthree-piece recorded as fairly low. Level of Evi-dence 3, strength of recommendation C.

• Future studies reporting device survival shouldexpress this by using Kaplan-Meier projectionswhich allow meaningful comparisons of variousstudies and patients with differing follow-ups.Level of Evidence 3, strength of recommenda-tion C.

Prosthesis Satisfaction• Numerous studies have shown high satisfaction

rates for both patients and partners. Level ofEvidence 3, strength of recommendation C.

• One study demonstrated a higher satisfactionrate in men with penile prostheses over othertreatments for ED such as intracavernous pros-taglandin E1 injections, intraurethral alpros-tadil, vacuum erection devices, and oral PDE5inhibitors. Level of Evidence 3, strength of rec-ommendation C.

• Future satisfaction studies should be prospec-tive, include partners whenever possible, anduse standardized forms. A new form for satisfac-tion in penile prosthesis recipients needs to bedeveloped and validated. Level of Evidence 3,strength of recommendation C.

Vacuum Constriction Devices

HistoryThe first report on the concept of negative pres-sure being applied to the field of ED was by JohnKing, an American physician who described amethod of improving erections by a small vacuumpump [56]. In 1917, a patent was granted to OttoLederer for his surgical device to produce erec-tions with a combination of a vacuum and a com-pression ring, now known as the vacuum erectiondevice (VED) [57]. The credit for the populariza-tion of VED is attributed to a Georgian entrepre-neur, Geddins D. Osbon who (reluctant to accepthis own impotence) developed and constructed hispersonal VED in 1960. After perfecting the deviceon himself for over a decade, it became commer-cially available in 1974, but only in 1982 was hegranted permission from the Food and DrugAdministration to market the device (known as

Erec-Aid®), as a prescription product—the first ofits kind [58]. Since that time several patents havebeen granted, although they all share similardevice characteristics.

Devices and Mechanisms of ActionThere are currently a number of VED commer-cially available, all using the same principle, butvarying slightly in their method of inducing avacuum, in their pressure-release valves, and in theshape of the compression rings.

The standard VED consists of suction cylinderand pump to induce an erection by increasing cor-poral blood flow and then a compression bandplaced around the base of the penis to maintain theerection-like state by decreasing corporal venousdrainage after the suction device is removed.

Some models combine the suction cylinder andpump into one piece and most manufacturers offertheir device with a battery-driven motor to createthe vacuum. The cylinder is usually clear plasticand must be of sufficient length and diameter to fitover the erect penis. The cylinder has a pressurerelease valve designed to prevent penile injuryfrom excessive negative pressure.

The compression rings vary widely with regardto their thickness and grips, but some manufactur-ers have introduced shaped rings with a notch to fitover the urethra in an attempt to reduce ejacula-tory difficulties and to concentrate pressure ontothe corpora.

The base of the penis, the contact area of theVED, and the compression rings are lubricatedwith copious amounts of water-soluble jelly, andthe rings are fed over a loading cone to the base ofthe cylinder. The cylinder is then placed over theflaccid penis, pressed firmly against the pubic boneto obtain an airtight seal, and suction is applied fora few minutes to effect penile engorgement [59].Once an erection-like state has been produced,one or more bands, previously rolled onto the cyl-inder prior to the vacuum maneuver, are slippedfrom the cylinder onto the base of the penis, pre-venting venous return and maintaining tumes-cence [60]. Then, the vacuum is released via a valveand the cylinder is removed.

The compression rings are left in place nolonger than 30 minutes to avoid ischemic damagesto the cavernosal tissue; if intercourse is to beprolonged past this point, the band must beremoved, and after few minutes, the same proce-dure can be repeated. The time taken to obtain anerection varies but has been reported on anaverage between 2 and 2.5 minutes [61,62]. Inter-


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mittent pumping can improve penile rigidity,enabling more satisfactory penetration. Patientsshould be instructed to pump for 1 to 2 minutes,releasing pressure and then pump again for 3 to 4minutes [63]. Prescription devices are advised, andmetal or other inelastic rings are contraindicated[59].

Physiologic EffectsThe erection obtained with VED is not naturaland there are distinct differences in the physiologyof a spontaneous erection and that of an erectionfollowing use of a VED, as outlined by Nadid andassociates [64]. Although persistent reduced bloodflow during compression has been described byone group using plesthysmography, others usingduplex Doppler sonography found maintenance ofthe cavernous arterial inflow [65,66].

The VED promotes engorgement of the penisthrough negative pressure effects and blood istrapped in different compartments in the penis,including subcutaneous tissues and the sinusoidalspaces of the cavernous bodies whose diametersdouble [65]. Cavernosal blood gas analysis hasconfirmed that engorgement in the penis is com-posed of predominantly venous blood [67].

Vacuum pressures between 100 and225 mm Hg are necessary to achieve erection [66].Excessive negative pressure can cause bruising andhematoma, and to avoid injury to the penis, onlyVED containing a vacuum limiter should be used[68].

It is important that patients and their partnersbe informed that VED-derived erections are per-ceived differently when compared to naturallyoccurring erections. All turgidity is distal to theconstriction band and the crura are not involved inthe erection, causing some degree of instability,leaving the potential for pivoting at the base andoften requiring manual assistance to insert thepenis into the vagina.

Owing to extracorporeal congestion, the VED-erected penis appears more cyanotic, is cooler, andgirth is usually greater than a normal erection[61,67].

Results of VED TherapyAlthough VED have proven to be effective intreating ED, even in the era of PDE5 inhibitors,the literature consists largely of single centerobservational series, and a collection of small pro-spective clinical trials. Efficacy rates of 67 to 90%have been reported in achieving satisfactory erec-

tions but patient satisfaction rates with the deviceare lower, ranging from 34 to 68% [69–73].

There is a great deal of variability in the clinicalefficacy and satisfaction of VED therapy. In anevaluation of 216 consecutives patients, Cooksonet al. reported regular device use in 69%, with a90% chance of attaining good-quality erections.Patient and partner satisfaction was 82% and 89%,respectively [74]. Vrijhof et al. reported their expe-rience with 67 patients treated with VED, andadequate erections were reported by 72% [73]. Incontrast, the experience of other authors withpatient satisfaction using the VED has been con-sistently less.

In a retrospective study, Derouet et al. [75]evaluated the medical and psychological outcomeof the use of VED in the treatment of ED in 190patients using a questionnaire and a clinical exami-nation. 110 patients (57.8%) answered the ques-tionnaire. Twenty-two (20%) rejected the deviceprimarily and 34 (30.9%) after a period of up to 16weeks (primary rejection rate 50.9%). A secondarydrop-out rate of eight patients (7.3%) wasobserved after an intermediate time of 10.5months. Forty-two percent of patients were long-term users and were mainly subjects who did notrespond to intracavernosal pharmacotherapy.

The general low acceptance of VED therapy inthe treatment of mild, moderate, and severe EDwas revealed in the series of Dutta et al. that evalu-ated, using a long-term, prospective study, thesatisfaction rate, attrition rate, and follow-uptreatment of well-trained patients using a VED[56]. One hundred twenty-nine patients received afollow-up questionnaire regarding satisfaction,months of use, reasons for discontinuing, andfurther treatment. The overall attrition rateobserved was 65% and was lowest among patientswith moderate ED (55%). All patients with mildED discontinued use, and a large number (70%) ofpatients with complete ED also discontinued use.Of the patients who discontinued, most stoppedtreatment early (median 1 month, mean 4 months)and 63% did not seek further treatment. Thirty-five percent of patients were satisfied with thedevice and have continued to use it long term(mean 37 months).

Earle et al. conducted a retrospective survey toassess the use, efficacy and acceptance of the VEDamong 60 impotent men not satisfied with intrac-avernosal injection therapy and found a high dis-satisfaction rate with VED therapy [57]. Eighty-one percent of the men abandoned the deviceciting lack of efficacy.


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Certainly, organic impotence as a wholeresponds well to VED therapy, with satisfactoryerections expected in at least 70% of diabetics sub-jects, 93% with arteriopathy, 70% with venousleaks, and more than 90% following radical pros-tatectomy [58,69,74,76–79].

Patient and partner satisfaction appear to beclosely correlated and also depends on successfulerection [80].

Specialized and Combined UsesIn those patients in whom intracavernosal pharma-cotherapy has failed, the use of VED in combina-tion with vasoactive injection therapy may lead toan adequate erection. Chen et al. studied the effectof combining intracavernous injection and a VEDin 10 men with ED who previously failed attemptsat treatment with either method as monotherapy[81]. They conclude that VEDs can augment apartial response to intracavernous injection andthe combination may be an alternative treatmentbefore other more invasive treatments such as apenile prosthesis are considered.

Prostaglandin E1 agents delivered by intraure-thral administration can significantly increasevacuum-assisted erections. Combination therapycan increase both penile length and diameter [82].

The addition of a PDE5 inhibitor with VEDimproved sexual satisfaction and penile rigidity inpatients dissatisfied with VED alone after radicalprostatectomy. Raina et al. reported the efficacy ofcombining sildenafil citrate with a VED in menwith ED after radical prostatectomy [83]. A totalof 31 patients were instructed to take 100 mg ofsildenafil 1 to 2 hours before VED use for thepurpose of sexual intercourse. Patients used com-bination therapy for a minimum of five attempts.Of the 31 patients, 24 (77%) reported improvedpenile rigidity and sexual satisfaction. Of the 24men, 7 (30%) reported a return of natural erec-tions at 18 months using combination therapy,with 5 of 7 reporting erections sufficient forvaginal penetration.

The VED can also be used in men who eitherhave prosthesis in place but find these erectionsunsatisfactory, those with fibrosis of the erectiletissue secondary to priapism, or after an explantedprosthesis [84,85].

The VED has been used as a tissue expanderfollowing surgical correction of Peyronie’s diseasein order to maintain the elasticity of the tissues[86]. More recently, there has been interest in theuse of VED in early intervention protocols toaugment corporeal rehabilitation of post-radical

prostatectomy fibrosis. Raina et al. showed thatearly use of VED following radical prostatectomyfacilitates early sexual activity and potentially anearlier return of natural erections sufficient forvaginal penetration [87]. Kohler et al. in a pilotstudy on the early use of the VED after radicalretropubic prostatectomy showed that this form oftreatment improved early sexual function and pre-served penile length [88]. For some investigators,VED have become first-line therapy for preserva-tion of erectile function following treatment ofprostate cancer [89].

Side Effects and ContraindicationsAdverse effects are usually observed early in thetreatment and usually decrease with continued useof the VED. Pain on ejaculation is reported in3–16%, with an inability to ejaculate in 12–30%[62,74,90]. Pain may occur during the creationof the vacuum in 20 to 40% of users. Petechiaeor ecchymosis of the penis are reported in 25–39%, with bruising (especially at the position ofthe ring) in 6–20% [69,74]. Numbness duringerection is reported as the major problem in 5%[74].

Major complications are infrequent. Raredescriptions of isolated, serious adverse effectsafter VED use have been published includingpenile skin necrosis, urethral varicosites, captureof scrotal tunica within the penile shaft, Peyronie’sdisease, and Fournier’s gangrene [91–94].

There are few contraindications to this form oftherapy. Patients on anticoagulant therapy andpatients with bleeding disorders must use VEDwith caution [95]. Similarly, special attention mustbe given to patients with a tendency for spontane-ous priapism or prolonged erections [63].

ConclusionsUse of a VED is a safe and effective form oftherapy for men with ED. The British Society forSexual Medicine Guidelines, an evidence-basedguideline for the diagnosis and treatment of ED,concluded that oral pharmacotherapy with PDE5inhibitors and VED are the first-line therapy forED [96]. The importance of proper patient selec-tion improves outcome results as confirmed by theexperience of a number of authors. VED may beoffered preferentially to elderly patients whopartake in limited intercourse attempts versusyounger patients who document lower preferencefor VED because of unnatural erections and cum-bersome application.


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Levels of Evidence• VEDs are ED treatment devices that employ

the use of negative pressure to engorge the peniswith blood and constriction rings artificially trapblood in the penis. Studies have reported thetime to erection varies, but averages from 2 to2.5 minutes. Level of Evidence 3, strength ofrecommendation C.

• A number of studies have reported that erec-tions obtained with VEDs are unnatural andtherefore are distinctly different from naturalerections. Level of Evidence 3, strength of rec-ommendation C.

Results of VED Therapy• Considerable variability in clinical efficacy and

satisfaction has been reported, but, overall,organic impotence responds well to VEDtherapy, especially in those who do not respondwell to intracavernosal pharmacotherapy. Levelof Evidence 3, strength of recommendation C.

Specialized and Combined Uses• VED use can be combined with vasoactive

injection therapy, to give men adequate erec-tions in those whom monotherapy for ED hasfailed. Level of Evidence 3, strength of recom-mendation C.

• After radical prostatectomy, VED therapy com-bined with a PDE5i improved sexual satisfactionin patients dissatisfied with VED alone. Level ofEvidence 3, strength of recommendation C.

• VED therapy has also been used as a tissueexpander to maintain elasticity following cor-rective surgery for patients with Peyronie’sdisease. Level of Evidence 4, strength of recom-mendation C.

• Additionally, VED use is indicated for rehabili-tation of post-radical prostatectomy patients tofacilitate early sexual activity and potentiallyimprove early return of natural erections. Levelof Evidence 3, strength of recommendation C.

Side Effects and Contraindications• The most common VED side effects are painful

ejaculation, inability to ejaculate, generalizedpain, petechiae, bruising, and numbness. Levelof Evidence 3, strength of recommendation C.

• Serious complications from VED use are rare,but include penile skin necrosis, urethral vari-cosities, capture of scrotal tissues within thepenile shaft, development of Peyronie’s disease,and Fournier’s gangrene. Level of Evidence 3,strength of recommendation C.

VED: Basic PrinciplesExternally applied device mechanically effectspenile blood engorgement.

Cylinder/pump placed over the penis creates aclosed chamber; pump creates vacuum, drawingoxygenated blood into corpora.

Compression elastic ring then placed at base ofpenis to restrict flow of blood.

Erections are unnatural.Level of Evidence 3, Recommendation C.

Vacuum Erection Devices (VED)Results–Literature:–Largely of single observational series–Small prospective clinical trials–Efficacy and Satisfaction Rates:–Report by authors—67 to 90%–Report by patients—34 to 68%–Organic ED responds well to VED therapy–Patient and partner satisfaction appear to beclosely equal

Level of Evidence 3, Recommendation C

Specialized & Combined Uses of VED–Combined with vasoactive injection therapy*–Combined with intraurethral alprostadil therapy–Combined with PDE5 inhibitor therapy–Rarely in men who have “inadequate” penileimplant function

–To prevent penile fibrosis (after priapism orexplanted prosthesis)

–After surgical correction of Peyronie’s disease**–Corporeal rehabilitation after radical prostatec-tomy***

–*Level of Evidence 3, Recommendation C–**Level of Evidence 4, Recommendation C–*** Level of Evidence 3, Recommendation C

Side Effects and Contraindications–Pain during creation of vacuum—20–40%–Pain on ejaculation—3–16%–Inability to ejaculate—12–30%–Petechiae or ecchymosis—12–30%–Bruising—6–20%–Numbness during erection—5%–Rare side effects:• Penile skin necrosis• Urethral varicosites• Capture of scrotal skin• Peyronie’s disease• Fournier’s gangrene

*Level of Evidence 3, Recommendation C


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Arterial Revascularization

IntroductionThe prevalence of vascular disease increases withage and is a major cause of organic ED in men overthe age of 50. A number of medical conditionsor risk factors are associated with ED, includinghyperlipidemia, atherosclerosis, smoking, diabe-tes, obesity, and peripheral vascular disease. Thepathogenesis of ED in these patients appears, inpart, to be linked to endothelial dysfunction.

Arterial surgery for ED was popularized in the1970s and 1980s. It has since become clear thatED is often associated with generalized cardiovas-cular disease and many of the patients undergoingrevascularization surgery have intrinsic smoothmuscle dysfunction throughout their body. Forthis reason, the efficacy of penile revascularizationsurgery is controversial and considered by many tostill be experimental. Follow-up studies vary in theprocedure used and rarely document adequatelong-term objective follow up data.

BackgroundHistorically, the success of bypass grafting forcoronary artery disease suggested bypassingobstructed arteries could restore normal erectilefunction in men suffering from vasculogenic ED.

Pathogenesis of Arteriogenic Erectile DysfunctionIt is now evident that ED in patients with cardio-vascular disease is multifactorial in origin andcannot be simply attributed to only an impairmentof penile blood flow due to occlusion.

A number of in vitro and in vivo studies suggestthat both endothelial dysfunction and corporalsmooth muscle dysfunction are the main factorsleading to ED in these men.

Therefore, even if there is a reduction in bloodflow through the penile vessels, there often coex-ists underlying smooth muscle dysfunction thatlimits the success of any potential penile bypassprocedure. Hence, the only select group wherepenile revascularization surgery is likely to be suc-cessful is in young men with isolated arterial steno-sis following perineal or pelvic trauma.

Penile Vascular AnatomyThe main source of blood supply to the penisoriginates from the internal pudendal artery,although accessory contributions may arise fromthe external iliac, obturator, vesical, and femoralarteries. The internal pudendal artery becomes thecommon penile artery after giving off a branch inthe perineum.

The three branches from the common penileartery are named the dorsal, bulbourethral, andcavernous arteries. The cavernous artery furtherdelivers multiple helicine arteries, which supplythe cavernosal tissues and sinusoids. These heli-cine arteries are in a contracted state when thepenis is flaccid and vasodilate during erection.

The dorsal artery of the penis runs along thedorsal surface of the penis and supplies the glanspenis. The bulbourethral artery supplies both thebulb and corpus spongiosum, while distally thethree branches anastomose near the glans.

The History of Penile Revascularization SurgeryMichal [97] reported the first penile arterial revas-cularization, in 1973, by anastomosis of the infe-rior epigastric artery (IEGA) to the corpuscavernosum. This procedure produced only short-term success with ensusing fibrosis of the smoothmuscle and thrombosis of the anastomosis. TheMichal II procedure was then popularized, wherethe IEGA was anastomosed in an end-to-sidefashion to the dorsal penile artery. Hauri [98] pro-posed direct arterial anastomosis of the IEGA tothe dorsal artery, but in addition, incorporating thedeep dorsal vein into the anastomosis. In principle,arterialization of the dorsal vein would improvearterial flow to the corpora cavernosa in a retro-grade manner via the emissary veins.

Virag [99] and colleagues described a proce-dure in which the IEGA was anastomosed directlyto the deep dorsal vein, introducing the conceptof venous arterialization. Not only has Viragdescribed modifications of his technique (ViragI-VI), but also a number of other investigatorshave described other variations on this basic pro-cedure. The principles of surgery remain thesame, consisting of distal or proximal ligation ofthe arterialized vein, windows between the arteryand vein, and ligation of the circumflex vesselsand destruction of the valves in the dorsal vein. Intheory these modifications improve inflow, whilereducing venous outflow. In concept these proce-dures may be attractive not only in men with purearteriogenic ED, but also those with a venogeniccomponent.

Principles of Surgery for Arterial PathologyThe principles of revasularization and arterializa-tion surgery are based upon the following tech-niques (modified from Sohn [100]):

• Anastomosis of the IEA to the dorsal artery(revascularization).


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• Anastomosis of the IEA to the deep dorsal vein(arterialization)

• Anastomosis of the IEA to the deep dorsal veinwith venous ligation.

Selection and Investigation of the Patient withSuspected Arteriogenic EDPenile arteriography is the gold standard inassessing patient’s suitability for arterial recon-structive surgery. However, prior to embarkingupon this procedure, other organic causes of EDneed to be excluded. In those in whom arterialsurgery is contemplated, a penile duplex Dopplerstudy confirms vascular insufficiency and docu-ments any venous leak. A peak systolic velocity ofless than 25 cm per second suggests vascularinsufficency. Cookson [101] analyzed surgical out-comes based on the preoperative etiology ofimpotence (pure arterial versus arterial combinedwith corporeal venous leak). There was a signifi-cant improvement in surgical outcome in patientswith a pure arterial ED compared to those withmixed etiology (67% and 42%, respectively(P < 0.01). The authors suggest that in patientswith arteriogenic ED, concomitant corporealveno-occlusive dysfunction should be excluded bypreoperative dynamic infusion cavernosographyand cavernosometry (DICC), as this may furtherpredict postoperative success. A Rigiscan studymay be considered in the young patient with sus-pected arterial injury. Vardi [102] demonstratedthat patients under the age of 28 years showed a73% success rate vs. 23% in the older age group(Table 6). Furthermore, nonsmokers had a 57%success compared to 29% in smokers. They alsofound that the presence of venous leak and type ofprocedure had no significant impact on success.However, when patients without a venous leakwere compared to a group with moderate venousleak, the results showed a 73.3% success versus26.7%, respectively (P = 0.32). The authors arguethis conflicting result may have been proven sig-nificant with a larger number of patients in themoderate leak group (Table 6, Table 7).

In a further study [103], success in diabetics andolder patients was lower (43% for diabetics, 39%for those older than 50 years at surgery). Basedupon their experience, Zumbe [104] recom-mended the following important factors in caseselection for arterial surgery: (i) non-responder toICI; (ii) age less than 55 years; (iii) non-diabetic;(iv) cavernous leakage excluded; (v) stenosis in theinternal pudendal artery.

Therefore, based upon the literature, the fol-lowing appear to be inclusion criteria in selectingpatients for arterial surgery:

• Age less than 55 years• Non-smoker• Non-diabetic• Absence of venous leakage• Stenosis of the internal pudendal artery

Complications from Penile Revascularization SurgeryA number of authors have described complicationsfollowing penile revascularization procedures[103,105,106].

The most frequent complication is glans hype-remia. In a series reported by Manning [103] glanshyperemia developed in 13% of patients, shuntthrombosis in 8%, and inguinal hernias in 6.5%.

Table 6 Success and failure rates according to riskfactors, From Vardi et al. [102]

Variable Success n (%) Failure n (%)

Age (2-y follow-up)Young <28 years 19 (73) 7 (27)Old >28 year 6 (23) 20 (77)

Age (5-y follow-up)Young <28 year 10 (77) 3 (23)Old �28 year 7 (32) 15 (68)

TobaccoSmokers 5 (29) 12 (71)Nonsmokers 20 (57) 15 (43)

Venous leakNone 11 (64) 6 (36)Mild 10 (38) 16 (62)Moderate 4 (44) 5 (56)

Type of surgeryIEA to DA 4 (40) 6 (60)IEA to DV 12 (41) 17 (59)IEA to DA and DV 8 (51) 5 (49)

Table 7 Odds ratio of success according to risk factor

Odds ratio 95% CI

AgeYoung vs. old 9.05* 2.72–34.45Young vs. old (5-y follow-up) 7.14* 0.24–1.85

TobaccoNonsmoker vs. smoker 3.2* 1.00–11.9

Venous leakNone vs. any leak 2.75** 0.85–9.65None vs. moderate 2.29 0.44–12.75Mild vs. (moderate and none) 2.18 0.73–6.80Moderate vs. (mild and none) 1.19 0.28–5.40

Type of surgeryIEA to DA vs. all 1.36 0.34–5.99IEA to DV vs. all 1.55 0.51–4.73IEA to DA and DV vs. all 2.30 0.65–8.86

*Statistically significant as determined by Wald’s test (P � 0.05).**Statistical trend determined by Wald’s test as 0.05 < P < 0.


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Outcomes from Penile Revascularization Surgery inMen with Arteriogenic EDTable 8, adapted from Sohn [100], summarizes theoutcome for penile revascularization surgery. Thisdata was published for the 2nd International Con-sultation of Sexual Dysfunction.

Surprisingly, there has only been one retrospec-tive case series published in the literature since2003 [111]. The lack of further studies may reflectconsensus opinion, such as American UrologicalAssociation (AUA) guidelines [68] which statethat, “Treatment of vasculogenic ED by penilearterial revascularization has been performedusing a variety of microvascular procedures for thepast 30 years. The efficacy of this surgery isunproven and controversial largely because, inmost reported studies, selection and outcome cri-teria have not been objective and because a varietyof surgical techniques have been used.”

The 2005 guidelines are based upon the 1996guidelines report following a meta-analysis of thisliterature. The AUA’s Clinical Guidelines Panel,in 1996, stated arterial surgery was not justified tobe performed routinely, although, arterial revascu-larization procedures appeared to have the highestefficacy in young men with ED secondary to arte-rial injury from pelvic or perineal trauma. Onlyfour articles with a total of 50 patients met thePanel’s inclusion criteria (Table 9). These studieswere retrospective with small numbers of patients.Objective outcome was not measured uniformlyand follow up interval in most studies was short(Table 10).

One of the largest contemporary retrospectiveseries is that of Kawanishi [105]. Although pub-

lished in 2004 and using the 1996 guidelines, thisstudy on 51 men with arteriogenic ED stands outfrom other retrospective series in terms of objec-tive outcome data reported by color Dopplerduplex studies and a longer follow up period. Priorto surgery all patients had a full assessment of theirED, which included intracavernosal pharmaco-logical erection tests, penile duplex Doppler,DICC, and digital subtraction angiography. Theetiology of the arterial lesions was blunt perinealtrauma in 33 and unknown in 35. Either the Haurior Furlow-Fischer procedure was used for penilerevascularization. The patency of the neoarterialblood flow was assessed objectively by color flowduplex Doppler. The mean (SD) subjectively esti-mated efficacy rate was 85.9 � 6.3%, after 3 and67.5 � 10.7% after 5 years of follow-up. Theobjectively estimated efficacy rate was 84.9 �7.3% at 3 and 65.5 � 13.5% after 5 years offollow-up.

In the second Paris consultation in 2003, theliterature from 1993 to 2003 was evaluated.Table 8 summarizes these studies and another twostudies (Wespes [115]) questioned the role of arte-rial surgery in men with vascular ED. They com-pared the sexual satisfaction rate in 130 patientswith arterial and/or venous impotence treated withfour surgical techniques with long-term follow up.Arterialization of the deep dorsal penile vein wasperformed in 39 (30%) and 78 (60%) were treatedwith penile implants. Sexual satisfaction, definedas the possibility of satisfactory sexual intercoursewithout any additional treatment or pain, wasevaluated by patient interview.

Of the evaluable patients, the sexual satisfactionrate was 12% for arterialization compared to 93%

Table 8 Outcomes from penile revascularization surgery(adapted from Sohn [100])

Study N ProcedureFU(months)

Overallintercoursesuccess

Jarow 1996 [107] 11 DDVA 50 92Lukkarinen 1997 [106] 24 Hauri 4

F-F14N/A 77

Manning 1998 [103] 62 ViragHauri

41 54

Manning 1998 [103] 42 DDVA N/A 57Kawanishi 2000 [108] 18 Dorsal Art

HauriFF

32 94

Sarramon 1997 [109] 114 Dorsal ArtDDVA

17 63

Sarramon 2001 [110] 38 DDVA 61 N/AVardi 2002 [102] 61 N/A 60 N/AKawanishi 2004 [105] 51 Hauri

Furlow36–60 85.9

Table 9 Penile arterial surgery: Criteria for articleselection by the AUA guidelines committee 1996 (updated2005)

Exclusion criteriaDiabetes mellitusCigarette smoking

Length of follow-up12 month minimum

Inclusion criteriaNormal serum testosteroneFailed pharmacologic erection test or documentation of

organicity by either abnormal nocturnal penile tumescence orabnormal penile blood flows (duplex Doppler ultrasonography(DICC)

Abnormal penile arteriogramArtery to artery or artery to dorsal vein anastomosis employed

in surgical techniqueObjective follow-up data reported by either duplex Doppler

ultrasonography, penile arteriogram, or validated outcomequestionnaire


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for penile prosthesis (mean follow-up was 46 and54 months respectively). The success rate foryoung patients with traumatic arterial lesions was100%. It is apparent from this 2003 study thatpatient outcome is poor in men undergoingarterialization compared to other treatmentmodalities.

Despite the negative opinion by the AUA con-sensus panel on penile revascularization surgeryand the poor outcome from the comparative studyby Wespes [115], Kayigil recently published apaper that supported the efficiency of deep dorsalvein arterialization (DDVA) in carefully selectedhealthy elderly patients [111]. Forty-three patientswith a mean age of 59.7 � -4.6 years underwentcorpus cavernosum electromyography, DICC, andpenile duplex Doppler ultrasonography. Riskfactors including hypertension, diabetes, hyper-lipidemia, smoking, psychiatric or neurologic dis-orders, liver or kidney failure, and a history ofmajor trauma were excluded. All patients under-went DDVA using the Furlow-Fisher technique.Surgical outcome was tested postoperatively usingthe IIEF-15. A surgical success was achieved if thescore in the five-item version of the IIEF (IIEF-5)had increased by at least five points. The meanfollow-up interval was 22.1 � 7.1 months. Veno-occlusive dysfunction was found in 21 patients, 13had arteriogenic disease, and 9 had both caverno-venous and arteriogenic disease. The operationwas deemed successful in 26 cases (60.5%) accord-ing to IIEF-5 criteria. The authors concluded thatDDVA can be performed in carefully selectedolder patients as long as the major risk factors forED are excluded. This latest paper adds little tothe previous retrospective series, as there is a shortfollow-up period and no objective data analyzingpre and postoperative erectile function with theexception of the IIEF questionnaire.

Outcomes from Penile Revascularization Surgery inMen Following Perineal TraumaEvidence supporting the traditional concept thatyoung men who undergo revascularization appearto have better outcomes compared to other groups

is still limited. However, the group of patients whoappear to have definite improved outcomes fromarterial revascularization remains young men whohave sustained blunt perineal or pelvic trauma.

In the study by Vardi [102], 10 patients haddocumented pelvic trauma with a mean age of 30years. In this group, all regained satisfactory erec-tile function at a two year follow-up. The youngertraumatic patients had an 80% success rate com-pared to 20% in the older men (P = 0.04). Thehigher success rates in younger men was also con-firmed by Wespes where the success rate for youngmen with traumatic arterial lesions was 100%[116].

More recently, Babaei [117] performed a meta-analysis and systematic review to determine thesubjective and objective outcomes of penile revas-cularization surgery in patients with arteriogenicED. Published articles were searched up toMay 2008 in the Cochrane Central Register ofControlled Trials, MEDLINE, EMBASE, andBiological Abstracts. Data on participants’ charac-teristics, study quality, population, intervention,cure and adverse events were collected and ana-lyzed. Not surprisingly, the results in men youngerthan 30 years old were better than older men. Theauthors conclude that “inconsistent measurementsof outcomes limited the findings, and none of thestudies were randomized controlled trials”.

Levels of Evidence• There are a large number of retrospective

studies reporting outcome data for penile revas-cularization surgery for arteriogenic ED. Level3 evidence.

• These studies are limited by variable inclusionand exclusion criteria, short length of follow-up,and lack of objective follow-up data. Level 3evidence.

• Young men who have sustained traumatic arte-rial lesions appear to have better outcomes com-pared to elderly patients. Level 3 evidence.

• There are no comparative prospective random-ized studies assessing outcome of penile revas-cularization surgery for arteriogenic ED. Based

Table 10 Original studies fulfilling the AUA 1996 guidelines committee inclusion criteria

Reference Type of SurgeryNumberof Patients

Months of follow-upoverall: range (Mean)

Success Rate%(N) Success Criteria

Ang and Lim (1997) [112] Dorsal vein 6 8 to 37 (20) 66 (4) NPT, DopplerDePalma et al. (1995) [113] Dorsal artery 11 12 to 48 60% (7) DopplerGrasso et al. (1992) [114] Dorsal artery 22 1 year for all 68 (15) 36 (8) NPT DopplerJarow and DeFranzo (1996) [107] Mixed 11 12 to 84 (50) 91 (10) Doppler DUS


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upon the evidence within the literature, thissurgery may be offered to men less than 55 yearsof age who are non-smokers, non-diabetic, withabsence of venous leakage and demonstrate anisolated stenosis of the internal pudendal artery.Level 3 evidence, recommendation D.

Surgery for Corporal Veno-OcclusiveDysfunction (CVOD)

BackgroundIn December 1992, the NIH held a ConsensusDevelopment Conference [118] on impotence andsuggested that arterial revascularization proce-dures have a very limited role.

Similarly, in 1996, the AUA released its guide-lines [59] on the management of ED, wherein itstated that “Venous surgery and arterial surgery inmen with arteriosclerotic disease are consideredinvestigational and should be performed only ina research setting with long-term follow-upavailable.”

The proceedings of the First Paris InternationalConsultation on Erectile Dysfunction [119] (1999)state that “. . . the immediate results are satisfac-tory but relapse can be observed a few monthslater . . . these patients must be evaluated by spe-cialized testing and should be treated at centerscapable of providing longitudinal follow-up, ifpossible within research protocols.”

The Second International Consultation onSexual Dysfunctions [120] (2003) was much lessoptimistic: “Revascularization and venous ligationprocedures have not demonstrated the necessarysurgical simplicity and reproducibility of results tomake them a widely applicable treatment optionfor erectile dysfunction . . . [121,122] . . . There isstill a need for further study with well defineddiagnostic criteria, surgical techniques, and stan-dardized patient and partner outcome assessment. . . It is the conclusion of this committee that withthe current review of evidence based analysis thereare no additional outcomes data of sufficientquality or quantity to supersede this recommenda-tion (viz. that of the NIH, 1993, and the AUA,1996).”

The Present (from the Second InternationalConsultation on Sexual Dysfunctions [123], 2003, tothe 3rd International Consultation on SexualMedicine, 2009)The important guideline publications in this timeperiod have been the AUA Update on the Man-

agement of ED, 2005 [68], and the ISSM’s Stan-dard Practice in Sexual Medicine [100] textbook:

“Penile Venous Reconstructive Surgery Rec-ommendation: Surgeries performed with theintent to limit the venous outflow of the penis arenot recommended. [Based on review of the dataand panel consensus.]

Since the publication of the 1992 NIH Consen-sus Statement and subsequently the 1996 Report,there has been no new substantial evidence tosupport a routine surgical approach in the man-agement of veno-occlusive ED. While the hemo-dynamics of veno-occlusive ED are recognized, itis difficult to distinguish functional abnormalities(smooth muscle dysfunction) from anatomicaldefects (tunical abnormality). It also is difficult todetermine what percentage of ED is due to veno-occlusive ED independent of general arterialhypofunction, how to accurately diagnose thiscondition, how often arterial insufficiency coexists,and whether or not there exists a subset of patientswith this disorder who would benefit from surgicalintervention. Currently, there is no evidence fromrandomized controlled trials documenting a stan-dardized approach to diagnosis or the efficacy oftreatment for veno-occlusive ED. This lack of newevidence suggests that no changes in the previousguideline statement are warranted.” (Chapter1–25)

The ISSM’s Standard Practice in Sexual Medicinestates that:

“Further research should focus on diagnosticpossibilities to differentiate isolated venousleakage from systemic intracavernosal disease.Results of evidence–based medicine meta-analysesin surgery of the venous system should be inte-grated in our future approaches. Basic research onintracorporal hemodynamics should be pursued.For future clinical studies, validated survey instru-ments such as the IIEF should be administeredboth pre- and postoperatively to determine long-term success.”

However, in spite of all these admonitions, areview of the recent literature on this subjectbetween 2003 and the present time of this writingshows there have been several publications on vir-tually every aspect of CVOD: basic science andhemodynamics [124–127], pathogenesis [128–132], investigations [127,133], surgery [111,134–140], prognosis [141,142], and post-operativechanges [143].

It must be conceded that some workers in thefield continue with the same old techniques ofdeep dorsal vein arterialization and penile vein


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ligation, or minor modifications of the same theme(the recent description of an otherwise innovativeextraperitoneal laparoscopic approach for ligationof the dorsal penile venous system is an exception).Today, it is agreed by most that venous leakage isan effect rather than a cause, and newer pathoge-netic mechanisms that cause CVOD, and thera-peutic possibilities that might address these causes,are being examined. The hunt for an effective sur-gical cure is still on.

And the FutureIt would be utopian to have an oral pill for allCVOD, engineered healthy cavernous smoothmuscle, or maybe an injectable endoluminal veinsealant. An aspect of CVOD that needs study is thephenomenon of crural compression. The observa-tion that compression of the crura of an erect penisincreases intracavernosal pressures in its distal cyl-inders and improves erection was first made byPuech-Leão et al. in 1987. Since then, althoughthere have been experimental and animal studies[31,144–147], its therapeutic potential in humanswith CVOD has not been exploited [148].

Appendix(The bullet points in these lists have been culledfrom various publications in the literature, collatedand merely presented as guidelines to workers inthe field of CVOD.)

1. CVOD Surgery—types of interventions• Superficial dorsal vein ligation• Deep dorsal vein ligation/excision• Crural vein ligation• Crural plication/ligation• Deep dorsal vein arterialization• Cavernosal vein arterialization• Spongiolysis• Pericavernoplasty• Therapeutic embolization• Combinations of the above• Extraperitoneal laparoscopic penile vein

ligation2. CVOD Surgery—complications / side effects

• Glandular hypo/ anesthesia• Skin necrosis• Wound infections• Penile curvature• Penile shortening• Glans hyperemia• Hematomas after DDV arterialization• Inguinal hernias• Penile edema

• “Vascular” pain after embolization proce-dures

3. CVOD—causes• Congenital vascular anomalies• Trauma• Arterial disease, e.g., hypercholesterolemia• Arteriosclerosis• Alterations in cavernosal smooth muscle, tra-

beculae, or tunica albuginea• Psychogenic• Post priapism• Unknown

Levels of Evidence and Recommendations1. At the time of this writing, CVOD surgery in

the management of ED remains controversial.Level of Evidence 3, strength of recommenda-tion C

2. The weight of available evidence is contrary toroutine use as a treatment option for ED. Levelof Evidence 3 strength of recommendation C

3. CVOD surgery, as it is practiced today, doesnot conform to the desiderata of good clinicalpractice (GCP) or evidence-based medicine(EBM). The normal diagnostic values for avail-able tests, universal diagnostic criteria for caseselection for surgery, consensus on choice ofoperation in a given patient, etc. have not beenunequivocally established. There is a need toestablish a Standard Operating Procedure(SOP) for CVOD. Level of Evidence 3,strength of recommendation C. While CVODsurgery is still considered investigational, it maybe offered in special situations. Level of Evi-dence 3, strength of recommendation C• With informed consent in writing in a teach-

ing hospital or an investigational or researchsetting. Level of Evidence 3, strength of rec-ommendation C.

• If CVOD is undertaken, it should berequired to follow an operated patient longterm (48 months postoperatively). Level ofEvidence 3, strength of recommendation C.

• Post operative follow-up should includeobjective evaluation of the penile vascularand erectile status. Level of Evidence 3,strength of recommendation C.

• Penile color duplex Doppler ultrasound aftercomplete cavernosal smooth muscle relax-ation is the gold standard investigation ofchoice for both pre op and post—op objec-tive assessment.

• Young patients with site—specific congeni-tal, post—traumatic or post—inflammatory


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leaks may also be considered for vein ligationsurgerywith informed consent. The choice of opera-tion offered should be decided on availablewisdom and infrastructure, the experienceand preference of the operating surgeon, andthe basis of the site, nature, and size of theleak. Level of Evidence 3, strength of recom-mendation C.

• Validated measuring instruments (e.g., IIEF)should be used both pre and post operatively.Level of Evidence 3, strength of recommen-dation C.

Corresponding Author: Wayne J.G. Hellstrom, MD,FACS, Tulane University School of Medicine, Depart-ment of Urology, 1430 Tulane Avenue SL-42, NewOrleans, LA 70112, USA. Tel: 504 587 7308; Fax: 504988 5059; E-mail: [email protected]

Conflict of Interest: Dr. Montague is a consultant forAmerican Medical Systems. No conflict of interest todeclare for Drs. Krishnamurti and Minhas.

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Implants, Mechanical Devices, and Vascular Surgery for Erectile Dysfunction

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