Mentor Alpha Research Articles

(103) 3-Piece Inflatable Penile Implant Pump Malfunction: Management using Pump Replacement Alone

Abstract Introduction Expert opinion is that when an implant malfunctions after 2 years it should be replaced in its entirety, despite the fact that reservoir removal is associated with serious potential complications. Furthermore, modern reservoir construction is such that material fracture and leak is rare. Objective In this time we reviewed our experience with replacing only the reservoir in patients with malfunctioning 3-piece inflatable implants resulting from pump breakdown. Methods The study population consisted of (i) men who had had 3-piece inflatable penile implant surgery (ii) with device malfunction (iii) resulting from pump malfunction (iv) who had all other components functional (v) who underwent pump replacement alone and (vi) had ≥5 years follow-up after device repair (clinic visit, telephone call, letter). Only patients who had undergone a single prior implant operation were included. At the time of the repair, the pump was removed and replaced with a new pump, making sure that both cylinders and reservoir were filled fully intraoperatively and retained all fluid that was instilled. At the postoperative appointment, all patients were retrained in the correct means of device inflation, specially focused on avoidance of pump torqueing. Results 88 patients had pump tubing blow-out upon delivery of the pump at a mean duration post-primary implant of 9 ± 11 (2-16) years. Mean age 62 ±14 years. All patients had either a Mentor Alpha-1 or a Coloplast Titan devices placed. Tubing disruption was present ≤1cm from pump itself in 66 (75%) or >1cm from the pump in 22 (20%) patients. 25% had a blow out of the pump-reservoir tubing, while 66 (75%) had a tear in the pump-cylinder tubing (46 frayed tubing, 20 compete transection), evenly distributed between right and left-sided tubing. With a mean follow-up of 7±2.5 years, none of the devices had failed again. Conclusions In patients with a malfunctioning penile implant with proven pump-only failure, replacing the pump is a viable repair option, thus, circumventing the need for reservoir placement. Disclosure No

A Survey of Patients with Inflatable Penile Prostheses: Assessment of Timing and Frequency of Intercourse and Analysis of Implant Durability

This study was conducted to determine how long after inflatable penile prosthesis (IPP) surgery patients attempt sexual intercourse and the frequency of subsequent relations. We also examined survival-related factors for the AMS 700 CX, Mentor Alpha 1, and Mentor Alpha Narrow Base. The aim was to survey men who received IPPs and collect information about their return to sexual function and frequency of use, and to assess the resilience of their devices. Phase I involved retrospective chart review of 1,298 virgin IPP surgeries performed by one surgical team from January 1992 to December 1998. Phase II included 330 subjects selected by stratified, systematic, random sampling from phase I patients. Data were collected by computer-assisted telephone interview, using a 27-question survey. All patients had been instructed to wait 4 weeks before using the implant and were taught how to inflate/deflate their prostheses at the 4-week postsurgical visits. The survey examines the length of time after surgery for men to resume sexual function. In the same study, information was garnered about mechanical durability of the device. Among phase I subjects, the 5-year survival rate was 83% (N = 1,069) for IPP revision for any reason. Of the 330 phase II subjects, 248 (75%) were successfully contacted; 199 (80%) responded to the full survey and 49 (20%) responded to selected parts of the survey. Sexual intercourse was resumed postoperatively at 1-4 weeks for 41% (78/190), at 5-6 weeks for 31% (59/190), at 7-8 weeks for 16% (30/190), and at >8 weeks for 12% (23/190) of the patients. More than 60% of patients reported using their IPP at least once weekly. The three-piece IPP has excellent 5-year survival rates. Most patients return to sexual activity relatively quickly, with high frequency of usage of their prostheses.

1380 LONG-TERM INFECTION OUTCOMES AFTER HYDROPHILIC COATED INFLATABLE PENILE PROSTHESIS IMPLANTS: 11 YEARS OF FOLLOW-UP

You have accessJournal of UrologySexual Function/Dysfunction/Andrology: Evaluation II1 Apr 20121380 LONG-TERM INFECTION OUTCOMES AFTER HYDROPHILIC COATED INFLATABLE PENILE PROSTHESIS IMPLANTS: 11 YEARS OF FOLLOW-UP Ege Can Serefoglu, Sree Harsha Mandava, Ahmet Gokce, and Wayne J.G. Hellstrom Ege Can SerefogluEge Can Serefoglu New Orleans, LA More articles by this author , Sree Harsha MandavaSree Harsha Mandava New Orleans, LA More articles by this author , Ahmet GokceAhmet Gokce New Orleans, LA More articles by this author , and Wayne J.G. HellstromWayne J.G. Hellstrom New Orleans, LA More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2012.02.1807AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Penile implant surgery continues to be a positive alternative for patients with severe ED. Historically, adverse events related to infection were 3-4% for original implants. Advancements in technology have contributed to improved efficacy and decreased adverse events, such as infection. This review of 36,391 implants compares the pre/post infection rates after the inclusion of a technological (hydrophilic) coating enhancement between two implantable, three-piece, penile prostheses (IPP), the Mentor Alpha 1® and the Titan® (Coloplast Corp., Minneapolis, MN). METHODS A substantial number of Alpha 1 and Titan implants reported into a volunteer, post-market registry, from July 14, 2000 to Sept 30, 2011 were reviewed and compared with infections reported in the product evaluation database. The advanced Titan includes hydrophilic coating across all components allowing for the absorption of an aqueous solution, while no components of the Alpha 1 employed a hydrophilic coating. Data was analyzed using a Pearson's chi-square test to determine significance of reduction in reported infection between the Alpha IPP and the hydrophilic-coated Titan IPP. RESULTS A total of 7031 implants and 322 infections (4.6%) were reported with the Alpha 1 implant, and 29,360 implants with 402 infections (1.4%) reported with the Titan implant, showing a statistically significant (p-value 0.0001) decrease in reported infections between the Alpha IPP and hydrophilic-coated Titan IPP. CONCLUSIONS New advances in technology continue to improve efficacy and decrease adverse events for patients with severe ED treated with penile implants. Significant decreases in reported infection rates between the non-coated Alpha 1 IPP and the hydrophilic-coated Titan IPP suggest that the technology may contribute to decreased infections. © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 187Issue 4SApril 2012Page: e560-e561 Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ege Can Serefoglu New Orleans, LA More articles by this author Sree Harsha Mandava New Orleans, LA More articles by this author Ahmet Gokce New Orleans, LA More articles by this author Wayne J.G. Hellstrom New Orleans, LA More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Using Wound Drains for the Uncomplicated Penile Prosthesis

No AccessJournal of UrologyOpposing Views1 Oct 2011Using Wound Drains for the Uncomplicated Penile Prosthesis Tobias S. Köhler and Wayne J.G. Hellstrom Tobias S. KöhlerTobias S. Köhler More articles by this author and Wayne J.G. HellstromWayne J.G. Hellstrom More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2011.07.042AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail References 1 : Multi-institutional outcome study on the efficacy of closed suction drainage of the scrotum in three piece inflatable penile prosthesis surgery. Int J Impot Res2005; 17: 535. Google Scholar 2 : Drain cultures in penile prosthesis implants. J Urol2008; 181: S448. Google Scholar 3 : Penile prosthesis cultures during revision surgery: a multicenter study. J Urol2004; 172: 153. Link, Google Scholar 4 : Closed suction surgical wound drainage after orthopaedic surgery. Cochrane Database Syst Rev2007; . July 18: CD001825. Google Scholar 5 : Breast augmentation with silicone implants: the role of surgical drainage—report on 502 consecutive patients. Eur J Plast Surg2006; 9: 9. Google Scholar 6 : Is a closed-suction drain advantageous for penile implant surgery?: The debate continues . J Sex Med2011; 8: 601. Google Scholar 7 : Management of penile implant complications. In: The Diagnosis and Management of Male Sexual Dysfunction. Edited by . New York: Igaku-Shoin1996. Google Scholar 8 : Minimally invasive infrapubic penile prosthesis. J Sex Med2008; 5: 15. Google Scholar 9 : Potentiation of wound infection by surgical drains. Am J Surg1976; 131: 547. Google Scholar 10 : A five-year prospective study of 23,649 surgical wounds. Arch Surg1973; 107: 206. Google Scholar 11 : Mentor Alpha 1 inflatable penile prosthesis: patient satisfaction and device reliability. Urology1994; 43: 214. Google Scholar 12 : Hematoma formation following penile prosthesis implantation: to drain or not to drain. J Urol1996; 155: 634A. abstract 1294. Google Scholar Division of Urology, Southern Illinois University School of Medicine, Springfield, IllinoisSection of Andrology, Tulane University School of Medicine, New Orleans, Louisiana© 2011 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 186Issue 4October 2011Page: 1187-1189 Advertisement Copyright & Permissions© 2011 by American Urological Association Education and Research, Inc.MetricsAuthor Information Tobias S. Köhler More articles by this author Wayne J.G. Hellstrom More articles by this author Expand All Advertisement PDF downloadLoading ...

Long-term patient satisfaction with the Mentor Alpha 1/Coloplast Titan ® IPP

Journal of Men's HealthVol. 7, No. 3 ISMH Congress 2010 AbstractsLong-term patient satisfaction with the Mentor Alpha 1/Coloplast Titan® IPPISMH World Congress 2010 Abstract 010F. CostaF. CostaSearch for more papers by this authorPublished Online:18 Nov 2013https://doi.org/10.1016/j.jomh.2010.09.011AboutSectionsView articleView Full TextPDF/EPUB ToolsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View article"Long-term patient satisfaction with the Mentor Alpha 1/Coloplast Titan® IPP." Journal of Men's Health, 7(3), p. 284FiguresReferencesRelatedDetails Volume 7Issue 3Oct 2010 InformationWPMH GmbHTo cite this article:F. Costa.Long-term patient satisfaction with the Mentor Alpha 1/Coloplast Titan® IPP.Journal of Men's Health.Oct 2010.284-284.http://doi.org/10.1016/j.jomh.2010.09.011Published in Volume: 7 Issue 3: November 18, 2013PDF download

1070 USE OF LENGTH EXPANSION INFLATABLE PENILE PROSTHESES IN MEN WITH ERECTILE DYSFUNCTION SECONDARY TO PEYRONIE'S DISEASE

You have accessJournal of UrologySexual Function/Dysfunction/Andrology: Peyronie's Disease/Surgical Therapy I1 Apr 20101070 USE OF LENGTH EXPANSION INFLATABLE PENILE PROSTHESES IN MEN WITH ERECTILE DYSFUNCTION SECONDARY TO PEYRONIE'S DISEASE Benjamin Whittam, Todd Doran, Melissa Kaufman, and Douglas Milam Benjamin WhittamBenjamin Whittam More articles by this author , Todd DoranTodd Doran More articles by this author , Melissa KaufmanMelissa Kaufman More articles by this author , and Douglas MilamDouglas Milam More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2010.02.2229AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Implantation of an inflatable penile prosthesis (IPP) with molding is an effective and durable treatment for erectile dysfunction (ED) and moderate penile curvature due to Peyronie's disease (PyD). Current literature and dogma support use of the American Medical Systems (AMS) CX model or the Mentor Alpha 1 IPP because lengthening capacity of other models is thought to prohibit adequate rigidity for molding and straightening, however, these devices may result in the perception of decreased penile length. Herein we report our experience with placement of length expansion IPP models in the Peyronie's population. METHODS Retrospective review of medical records was performed for patients with ED and penile curvature that had undergone AMS Ultrex or LGX IPP implantation from January 2004 to February 2009. Charts were evaluated for demographics, perioperative curvature, voiding symptoms, erectile function, outcomes, and complications. RESULTS Forty-nine patients underwent AMS Ultrex or LGX implantation for ED associated with PyD. Mean patient age at time of surgery was 60 years (range 45 – 79 years). All patients presented with ED and penile curvature with an average penile curve of 52.9 degrees. Postoperatively, of the 40 patients with sufficient follow-up, 22 had no residual curve and the 18 had an average residual curve of 17.7 degrees. Sexual Health Inventory for Men scores increased from a preoperative mean of 6.97 to 18.54 postoperatively (p=0.0001). AUA-SS mean scores remained stable from 9.11 preoperatively to 7.77 at last follow-up (p=0.80). Excluding 2 patients not sexually active, 87% reported satisfaction with their IPP, while the percentage able to have intercourse increased from 30.8% preoperatively to 97.3% postoperatively. 31 patients underwent molding at time of operation, with no reported cases of aneurysmal dilatation. There were no device infections, one hematoma and one revision due to reduced glans support. No devices were explanted secondary to issues with penile length. CONCLUSIONS Even in patients with severe curvature and ED secondary to PyD, implantation of the AMS Ultrex or LGX IPP results in substantial improvements in curvature, erectile function and sexual health. This data expands current clinical strategies for treatment of this complex patient population by demonstrating the AMS Ultrex and LGX devices are viable therapeutic options for PyD, providing substantial resolution of penile deformities without perceived loss of length and accompanied by an acceptable morbidity profile Nashville, TN© 2010 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 183Issue 4SApril 2010Page: e417 Advertisement Copyright & Permissions© 2010 by American Urological Association Education and Research, Inc.MetricsAuthor Information Benjamin Whittam More articles by this author Todd Doran More articles by this author Melissa Kaufman More articles by this author Douglas Milam More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

T05-O-17 Penile prosthetic implants in man older than 65 years of age

Patients over 65 years of age would like to continue in enjoying sexual activity but sometimes they suffer some metabolic or vascular pathology interfering with correct erection. 868 patients, between 65 and 80 years of age, visited our centre from 1986 to 2006, complaining ED and searching a medical treatment or solution. We considered 15 patients (68-80 yrs) submitted to penile implants. All pts were married; 3 of them reported not to have sexual activity with their wives. All pts refused ICIs, Sildenafil or Vacuum Devices. Penile prostheses were proposed as the only option to restore their penetrative function and 15 pts accepted. AMS600 (5 pts), Mentor Acu Form (3 pts), AMS Hydroflex (1 pt), AMS Dynaflex (2 pts), Mentor Alpha I (2 pts), AMS 700 (2 pts) prostheses. Spinal (13 pts) and local anaesthesia (2 pts) were utilized. All patient were checked 12 months after surgery. After one year we recorded 4 deaths, not linked to prostheses or sexual intercourses. 3 pts had prostatic surgery 2-3 years after prosthetic implant. Only 2 patients reported general unsatisfaction probably due to a scarce acceptance or refusal by their wives. 13 patients reported complete satisfaction to the annual control and follow-up. Data of our experience show that the prosthetic solution can represent a valid option for patient over 65 who desire to maintain their sexual function and who do not respond or can not currently use other available pharmacological solutions.

Long-Term Survival of Inflatable Penile Prostheses: Single Surgical Group Experience with 2,384 First-Time Implants Spanning Two Decades

Long-term revision-free survival, greater than 10 years has never been reported for inflatable penile prostheses. We conducted a historical prospective study to estimate 10 and 15 years survival of first time (virgin) implantations in 2,384 patients with four different models. Evaluation of 10- and 15-year mechanical and overall revision-free survival of inflatable penile prostheses. Kaplan-Meier product limit method, and comparison using the log rank test, were used to estimate the 10- and 15-year revision-free survival. Data were obtained from medical records and patient interviews, entered into a computerized database, and analyzed by a third party. Information included implant type, date, revision history with date, and reason. Fourteen different inflatables were examined. Mentor Alpha 1, Mentor Alpha NB, AMS 700 CX, and AMS 700 Ultrex had usage for an extended period of time. Because of failure times being confounded as a result of prior implants, only virgin implants were examined. For the entire series, estimated 10-year revision-free survival for all reasons was 68.5% and the 15-year revision-free survival was 59.7%. Freedom from mechanical breakage at 10 years was 79.4%; 15 years was 71.2%. Recent mechanically enhanced models did even better. In 1992, Mentor Alpha added pump reinforcement to forestall mechanical breakage. This improved 10-year survival from 65.3% to 88.6% (P = 0.0001). In January 2001, AMS CX added a parylene coating to the cylinders that increased 3-year mechanical survival from 88.4 to 97.9% (P = 0.0002). This is the first report on long-term reliability of inflatable penile prostheses. We estimated 60% of these virgin implants would survive 15 or more years without revision or extraction. Newer enhanced models are currently available, and our tracking predicts even better long-term survival for these devices.

Outcomes and Satisfaction Rates for the Redesigned 2-Piece Penile Prosthesis

We evaluated long-term viability, quality of life and satisfaction with the redesigned 2 piece Ambicor inflatable penile prosthesis. This device underwent revision of the rear tip extender and reinforcement of the pump tubing connection to decrease fluid leak failure in 1998. In this retrospective analysis we evaluated 146 men with erectile dysfunction at 2 centers who underwent device implantation between June 1999 and October 2004 with the redesigned prosthesis. Patient information forms were completed, including patient history, surgical information and revision data. Patients were mailed a modified Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire, a modified Erectile Dysfunction Inventory of Treatment Satisfaction Partner survey and a questionnaire regarding pertinent inflatable penile prosthesis questions. A total of 146 men with a mean age of 58.7 years (range 25 to 78) were evaluated after inflatable penile prosthesis placement. Time from implant to followup was 3 to 73 months (mean 38). Only 1 device (0.7%) was removed due to infection. One implant (0.7%) was replaced due to fluid loss and 1 (0.7%) was revised due to improper sizing. Kaplan-Meier life table analysis indicated that the percent of patients free from reoperation was 99.2% at 12 months, 99.2% at 36 months and 91% at 48 months or greater. Of the 101 subjects completing the survey the average patient used the prosthesis 5 times monthly and 88.9% reported continued use. Of the patients 91% said that it was easy to use and 95% had little to no trouble learning to use it, while 84% stated that the inflatable penile prosthesis provided good to excellent rigidity for coitus. Overall patient and partner satisfaction was 85% and 76%, respectively. Of the patients 86% said that they would recommend the prosthesis to friends or if need be undergo the procedure again. The redesigned Ambicor 2-piece penile prosthesis appears to be safe and effective. It is associated with a low rate of revision as well as high patient and partner satisfaction.

ORIGINAL RESEARCH—SURGERY: Upsizing of Inflatable Penile Implant Cylinders in Patients with Corporal Fibrosis

Placement of an inflatable penile prosthesis in a patient with scarred corporal bodies secondary to priapism or removal of a previously infected implant is a formidable surgical challenge; use of downsized implants has improved chances of successful reimplantation. Nevertheless, patients are frequently dissatisfied with the resulting short penises. This study investigates the use of downsized inflatable penile prosthesis cylinders as tissue expanders in patients with corporal fibrosis. Corporal length and width were calibrated before implantation of downsized prostheses and after 1 year of their use as tissue expanders. Thirty-seven patients had insertion of Mentor Narrow Base (18), AMS CXM (9), or AMS CXR (10) into scarred corporal bodies. Etiology was previously infected and removed implant (29) or priapism (8). In each of these cases it was not possible to dilate to 12 mm in order to place standard-sized cylinders. Patients were encouraged to inflate their implant for up to 3 hours daily. After several months intracorporal stretching occurred. The patients were reoperated; corporal length and width were recalibrated. Upon reoperation, it was possible to pass dilators of 12 mm width proximally allowing the substitution of standard-sized AMS 700 CX (23), Mentor Alpha 1 (10), or Mentor Titan (2). Additionally, corporal length measurements in the previously infected patients increased an average of 2.2 cm allowing placement of longer cylinders. Although priapism patients did not show this phenomenon of corporal lengthening, the implant space widened enough to permit replacement with standard-size cylinders improving girth, rigidity, and appearance. Wider and sometimes longer cylinders can be substituted in patients with corporal fibrosis that required implantation with downsized cylinders because of fibrotic corpora. Prolonged inflation over an 8- to 12-month period results in expansion of the cylinder cavity, permitting standard-sized cylinders in all patients.

The mentor Alpha 1 penile prosthesis with reservoir lock-out valve: effective prevention of auto-inflation with improved capability for ectopic reservoir placement.

Auto-inflation is a common and annoying complication of 3-piece penile prostheses. In the published literature the rate is approximately 11% with a 2% operative revision rate. We report the results of a review of 160 Alpha 1 and NB implants (Mentor Corp., Santa Barbara, California) with the new lock-out valve located on the reservoir to treat impotence. We compared it with 339 Alpha 1 implants with the standard reservoir. We also investigated the lock-out reservoir for ectopic nonretropubic implantation. We compared 339 Alpha prostheses with the standard reservoir that were implanted between January 1, 1998 through December 31, 1999 and 160 with the new lock-out valve placed since January 2000 with at least 6 months of followup. Implants were further stratified as first time (virgin) or revision-replacement of a previous implant. In 8 patients with a scarred or obliterated retroperitoneal space the lock-out reservoir was placed superior to the transversalis fascia and beneath the abdominal musculature. Kaplan-Meier estimated 1-year survival was not significantly different in terms of mechanical failure (p = 0.57 and 0.85) revision for any cause (p = 0.92 and 0.92), patient dissatisfaction (p = 0.35 and 0.11) or infection (p = 0.64 and 0.94) for all implants and virgin implants only, respectively. Only 2 patients (1.3%) with a lock-out valve complained of auto-inflation initially and the problem resolved in each after instruction on how to operate the device. Of the patients in the earlier series 11% complained of auto-inflation and 2% required operative correction. None of the 8 patients with an ectopic reservoir location complained of auto-inflation. Our results indicate that the lock-out valve prevents early auto-inflation. Addition of the lock-out valve does not impact the revision rate compared with the same implant with a standard reservoir. In patients with a scarred retropubic space the lock-out valve offers the penile implant surgeon a decreased probability of auto-inflation with ectopic reservoir placement.

A SURVEY OF PATIENTS WITH INFLATABLE PENILE PROSTHESES FOR SATISFACTION

We assessed patient satisfaction with 3 types of penile prostheses, namely the AMS 700 Series(R), Mentor Alpha 1(R) and Mentor Alpha NB(R). The subjects consisted of 330 patients selected by stratified, systematic random sampling from among 1,298 subjects undergoing virgin 3-piece inflatable penile implant surgeries performed by the same surgical team at 1 hospital between January 1992 and December 1998. Data were collected by computer assisted telephone interviewing with a survey developed by the authors. The survey consisted of 37 questions in 7 sections, including 1 demographic section and 6 patient satisfaction sections. Of the 330 patients selected 248 (75%) could be contacted. Of these, 199 (80%) responded to the full survey and the remaining 49 (20%) agreed to respond only to the question, "How satisfied are you with the prosthesis?" Of the 199 full responders 12 (6%) had AMS implants and 187 (94%) had Mentor implants. Of the 49 single question responders 5 (10%) had AMS implants and 44 (90%) had Mentor implants. Of the 248 patients the overall satisfaction rate was 69%. Although there was no significant difference at the 5% level in patient satisfaction by implant type, responses tended to favor the Alpha IPPs in terms of overall sexual satisfaction (p =0.058), natural feeling of the prosthesis (p =0.061), flaccid appearance of the penis when deflated (p =0.054), and education with demonstration of inflation and deflation (p =0.075). There was a high degree of overall patient satisfaction across implant types.

CHAPTER 1: THE MANAGEMENT OF ERECTILE DYSFUNCTION: AN AUA UPDATE

approach to develop a guideline for the ED treatment modalities that had become available in the United States after publication of the 1996 Report. Guideline statements from the 1996 Report on previously available therapeutic modalities were either revised or brought forward unchanged depending on the existing evidence. All guideline statements were graded according to the degree of flexibility in clinical application: standard, recommendation, or option, with standard being the least flexible and option being the most flexible (Table 1). Grading is based on two characteristics: knowledge of the health outcomes of the alternative intervention and preference for the intervention. The Panel believed that the patient, with physician guidance, must make his own decision in selecting treatment. Outcome estimates derived from review and meta-analysis of evidence provide physicians and patients with scientifically based information to assist them in making appropriate treatment decisions. Thus, a second Panel objective was to determine whether or not there was sufficient evidence for outcomes (both benefits and risks) to be estimated.

Clinical experience with the mentor alpha-1 inflatable penile prosthesis: Report on 65 patients

To evaluate the complications and prosthesis survival associated with implantation of the Mentor Alpha-1 inflatable penile prosthesis (IPP) for the treatment of erectile dysfunction (ED). Between August 1995 and March 2003, 65 patients underwent implantation of a Mentor Alpha-1 IPP at the Urological Departments of Skejby or Aalborg University Hospitals. Patient data were obtained retrospectively from medical files. The follow-up period ranged from 1 to 96 months (median 48.5 months). Twenty-one patients (32%) experienced complications that required revision. The majority of complications consisted of mechanical problems, but infection was also a large contributor to the complication rate. Seven patients (11%) had the prosthesis permanently removed due to infection. Kaplan-Meier estimates of the 5-year prosthesis survival rates with and without successful revisions due to complications were 88% and 63%, respectively. The Mentor Alpha-1 IPP is an efficient treatment for ED in situations where less invasive therapy has failed. The risk of infection or mechanical failure must not be ignored. Patients should be informed of this risk before agreeing to implantation surgery.

Patient and partner satisfaction with the mentor alpha-1 inflatable penile prosthesis

To evaluate the satisfaction level of patients and partners after implantation of a Mentor Alpha-1 inflatable penile prosthesis (IPP) for the treatment of erectile dysfunction (ED). A questionnaire was sent to 46 patients who had been operated on for ED with implantation of a Mentor Alpha-1 IPP. The investigation was designed to evaluate patient and partner satisfaction. Eighty-five percent of the questionnaires were returned. Sexual desire had not changed but the quality of sexual activity had significantly improved. Acceptance by the partner was good. Overall satisfaction among both patients and partners was high. In total, 95% of patients said that they would recommend the procedure to other patients in the same situation. Patient and partner satisfaction with the Mentor Alpha-1 IPP was high, with the exception of the minority of patients who experienced unacceptable complications. Infection and mechanical failure are important risks which patients should be informed of before agreeing to implantation surgery.

Spontaneous tumescence after implantation of three-piece hydraulic penile prostheses: a short-term experience.

We evaluated spontaneous tumescence after penile prostheses implantation in a retrospective study. A total of 32 patients with three-piece hydraulic implants (17 Mentor Alpha I, 15 AMS Ultrex Plus) were enrolled. Consultation, personal interviews and questionnaires for both the patients and their partners provided the necessary information. The average follow-up period was 29 months. In total, 50 % of the patients reported spontaneous tumescence without activation of the implant and one further patient (3%) claimed full rigid spontaneous erections. General satisfaction with the prosthetic result was high at 91%. The following complications arose: one case of prosthesis infection, one case of mechanical failure, one case of cylinder dislocation and two cases of paraphimosis. A possible explanation for spontaneous tumescence after penile prosthesis implantation is the elevated preload of the compressed rather than destructed cavernous tissue. The artificial erection evoked by the prosthesis then takes the form of a normal physiological reaction and/or a good objective ridigity, and could account for the high patient satisfaction rate with three-piece hydraulic implants.

Inflatable penile prosthesis: site-specific malfunction analysis.

The purpose of this study was to analyze retrospectively the exact site(s) of device failure of a large series of Mentor Alpha I inflatable penile prostheses. The study consisted of 442 patients implanted over a 12-year period. Only those patients who developed a device malfunction and returned for re-evaluation by the author were included. The exact site(s) of device malfunction were obtained from a review of operative reports. The average length of follow-up in this series was 63 months, ranging from 1 to 138 months. In all, 22 (4.98%) patients developed device malfunction and returned for evaluation, including six (3.9%) of the 154 infrapubic devices and 16 (5.6%) of the 288 scrotal devices. Of these 22 patients, three declined revision and 19 were reoperated on by the author. The exact site of malfunction differed in the infrapubic vs scrotal implants. Most malfunctions of the scrotal device involved tubing fractures at the pump strain reliefs, whereas infrapubic device malfunctions typically involved the cylinders or the reservoir. A review of these malfunction patterns may assist the manufacturer in further improving the reliability of this prosthesis, and may assist implanting surgeons in planning operative procedures.

The Mentor Alpha 1 Penile Prosthesis With Reservoir Lock-out Valve: Effective Prevention of Auto-inflation With Improved Capability For Ectopic Reservoir Placement

The Mentor Alpha 1 Penile Prosthesis With Reservoir Lock-out Valve: Effective Prevention of Auto-inflation With Improved Capability For Ectopic Reservoir Placement

The Mentor Alpha 1 Penile Prosthesis With Reservoir Lock-out Valve: Effective Prevention of Auto-inflation With Improved Capability For Ectopic Reservoir Placement

Auto-inflation is a common and annoying complication of 3-piece penile prostheses. In the published literature the rate is approximately 11% with a 2% operative revision rate. We report the results of a review of 160 Alpha 1 and NB implants (Mentor Corp., Santa Barbara, California) with the new lock-out valve located on the reservoir to treat impotence. We compared it with 339 Alpha 1 implants with the standard reservoir. We also investigated the lock-out reservoir for ectopic nonretropubic implantation. We compared 339 Alpha prostheses with the standard reservoir that were implanted between January 1, 1998 through December 31, 1999 and 160 with the new lock-out valve placed since January 2000 with at least 6 months of followup. Implants were further stratified as first time (virgin) or revision-replacement of a previous implant. In 8 patients with a scarred or obliterated retroperitoneal space the lock-out reservoir was placed superior to the transversalis fascia and beneath the abdominal musculature. Kaplan-Meier estimated 1-year survival was not significantly different in terms of mechanical failure (p = 0.57 and 0.85) revision for any cause (p = 0.92 and 0.92), patient dissatisfaction (p = 0.35 and 0.11) or infection (p = 0.64 and 0.94) for all implants and virgin implants only, respectively. Only 2 patients (1.3%) with a lock-out valve complained of auto-inflation initially and the problem resolved in each after instruction on how to operate the device. Of the patients in the earlier series 11% complained of auto-inflation and 2% required operative correction. None of the 8 patients with an ectopic reservoir location complained of auto-inflation. Our results indicate that the lock-out valve prevents early auto-inflation. Addition of the lock-out valve does not impact the revision rate compared with the same implant with a standard reservoir. In patients with a scarred retropubic space the lock-out valve offers the penile implant surgeon a decreased probability of auto-inflation with ectopic reservoir placement.

LONG-TERM FOLLOWUP OF TREATMENT FOR PEYRONIE’S DISEASE: MODELING THE PENIS OVER AN INFLATABLE PENILE PROSTHESIS

We originally reported inflatable penile implants used to treat impotence in patients with Peyronie's disease in 1993. We now present a historical prospective study of 104 patients in whom the modeling procedure was used to correct Peyronie's curvature after implantation with the Mentor Alpha 1dagger and AMS 700CXdouble dagger penile prostheses. We compared revision-free survival experience of these implants with 905 similar implants in men with nonPeyronie's disease. The reasons for revision were classified as mechanical failure, patient dissatisfaction, infection and medical causes, including reoperation for straightening. Overall and cause specific revision-free survival in the 2 study cohorts was compared. Maximum followup was more than 12 years and average followup was more than 5. No significant difference in device survival was observed in the 2 study cohorts in 5 years. Similarly each prosthesis provided the same permanent straightening without the need for revision. In Peyronie's disease cases mechanical survival of the Mentor Alpha 1 was superior to that of the AMS 700CX (p = 0.0270). There was no significant difference in mechanical reliability of the devices in nonPeyronie's disease cases. Implantation and modeling appear to provide permanent straightening without an increase in revisions. In the nonmodeled group there was no significant difference in mechanical reliability of the AMS 700CX or Mentor Alpha 1. In modeled cases the Mentor Alpha 1 appeared less likely to fail mechanically than the AMS 700CX when followed more than 5 years. Based on this single series modeling may predispose the AMS 700CX to earlier mechanical failure.