Gerard D. Henry

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

PURPOSE 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. MATERIALS AND METHODS 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. RESULTS 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. CONCLUSIONS 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.

Centers of Excellence Concept and Penile Prostheses: An Outcome Analysis

PURPOSE Outcome analysis has shown that the center of excellence concept, in which all of a specific type of surgery is done by 1 surgeon rather than by multiple surgeons in a group, provides superior outcomes for total joint replacement, radical cancer and heart valve surgery. We compared penile prosthesis implantation outcomes between the center of excellence and multiple surgeon approaches in a large, single specialty urological surgical practice. MATERIALS AND METHODS Between February 2001 and August 2004 a total of 57 penile prostheses were implanted by 10 surgeons at a large urology practice (multiple surgeon group). Between July 2004 and April 2005 a total of 57 penile prostheses were placed by a single surgeon (center of excellence group). Chart review of the 2 patient groups was performed. RESULTS The patient groups showed no statistical differences in age, race, cause of impotence or percent with diabetes. The median cylinder length of prostheses placed by the center of excellence surgeon was 2 cm greater than the length of the cylinders placed by the multiple surgeon team (p <0.0001). Excluding cases requiring additional procedures the median placement time was considerably shorter for the center of excellence surgeon than for the multiple surgeon team (34 vs 94 minutes, p <0.0001). There were 8 iatrogenic failures (infection, erosion and poor positioning) requiring surgical removal in the multiple surgeon group but none in the COE group (p <0.05). Although followup for the multiple surgeon team was longer, Kaplan-Meier revision-free survival curves showed significantly longer survival for the center of excellence group (log rank test p = 0.0283). CONCLUSIONS The center of excellence concept in penile prosthesis surgery appears to deliver superior surgical outcomes in terms of shorter operative time, longer cylinders and fewer iatrogenic complications.

Perineal Approach for Artificial Urinary Sphincter Implantation Appears to Control Male Stress Incontinence Better Than the Transscrotal Approach

PURPOSE Traditionally cuff placement of an artificial urinary sphincter is done through a perineal approach. A new approach through a penoscrotal incision or transscrotal approach is reportedly more rapid and easier than the traditional incision. These 2 approaches were evaluated to determine which one controlled male stress urinary incontinence better. MATERIALS AND METHODS We performed a retrospective chart review of 94 patients who underwent artificial urinary sphincter placement procedures from April 1987 to March 2004. RESULTS A total of 126 artificial urinary sphincter cuffs (120 procedures, including double cuff placement in 6) were placed in 94 patients with 63 placed penoscrotally and 63 placed perineally. Of the double cuff placements 1 was perineal and 5 were transscrotal. In patients with a single initial or revision cuff the self-reported completely dry rate was 28.6% with the penoscrotal approach and 56.5% with the perineal approach (p = 0.01), while for initial cuffs only the dry rate was 28.0% and 56.7% for the penoscrotal and perineal approach, respectively (p = 0.03). Five of 28 patients (17.9%) with initial penoscrotal placement later underwent tandem cuff placement for continued incontinence, whereas only 1 of 32 (3.1%) with initial perineal placement later had a tandem cuff added (p = 0.06). There was no difference in the estimated failure-free survival (failure for any reason) of the device. CONCLUSIONS When the artificial urinary sphincter cuff is placed through a perineal approach, there appears to be a higher completely dry rate and fewer subsequent tandem cuff additions than when the artificial urinary sphincter cuff is placed through a penoscrotal incision.

An Outcomes Analysis of over 200 Revision Surgeries for Penile Prosthesis Implantation: A Multicenter Study

INTRODUCTION Inflatable penile prosthesis (IPP) implantation is a well-established treatment for medically refractory erectile dysfunction, with long-term reliability. Overall survival is 96% at 5 years and 60% at 15 years for primary (virgin) implantation. AIM The aim of this study was to explore factors associated with success and complications of IPP revision surgery in a multicenter study. MAIN OUTCOME MEASURES Reasons for revision including mechanical issues, patient dissatisfaction, corporal deformity, and supersonic transport (SST) deformity were recorded. METHODS At four institutions, 214 clinically uninfected IPP revisions were performed between November 2000 and November 2007. Data were incomplete for 28 cases (14%). Failure-free survival was estimated using Kaplan-Meiers Meier product limit method. RESULTS The majority of revisions were secondary to mechanical failure (N = 109; 65%) and combined erosion or infection (N = 17 + 15 = 32; 19%). Sixteen percent (N = 26) were carried out on functional uninfected prostheses secondary to patient dissatisfaction (N = 9), SST deformity (N = 10), scrotal hematoma (N = 2), or upsize revision because of corporal fibrosis (N = 5). Average age at revision was 66 years. Mean follow-up time was 55.7 months. In this study, 12 individuals required a secondary revision procedure or suffered a complication. Despite prior reports of high infection rates with revision surgery, only 5.7% of clinically uninfected and noneroded prostheses were complicated by infection or impending extrusion/erosion, following a revision washout protocol. Overall, 93% of cases were successfully revised, providing functioning IPPs. CONCLUSIONS For this study population, component exchange followed by revision washout showed a low incidence of infection and subsequent mechanical failure.

A Multicenter Study on the Perineal Versus Penoscrotal Approach for Implantation of an Artificial Urinary Sphincter: Cuff Size and Control of Male Stress Urinary Incontinence

PURPOSE In a single center retrospective study we previously reported superior dry rates and fewer artificial urinary sphincter revisions when the sphincter cuff was placed via the traditional perineal approach compared with a penoscrotal approach. A multicenter study was performed to compare the approaches further and explain the disparity in outcomes. MATERIALS AND METHODS We performed a retrospective review of 158 patients who underwent these procedures from April 1987 to October 2007 at 4 centers. RESULTS During 184 surgeries in 158 patients 201 artificial urinary sphincter cuffs were placed (90 penoscrotal and 111 perineal). Among patients with known followup the completely dry rate for single cuff artificial urinary sphincters was 17 of 62 (27.4%) in the penoscrotal group and 41 of 93 (44.1%) in the perineal group (p = 0.04). Continued incontinence necessitated subsequent tandem cuff in 7 of the 62 (11.3%) penoscrotal cases compared to only 5 of the 93 (5.4%) perineal cases. Cuff size in the penoscrotal group was 5.0 cm in 1 patient (1.1%), 4.5 cm in 11 (12.2%) and 4.0 cm in 78 (86.7%). Cuff size in the perineal group was 5.5 cm in 1 patient (0.9%), 5.0 cm in 8 (7.2%), 4.5 cm in 30 (27.0%) and 4.0 cm in 72 (64.9%). CONCLUSIONS There appears to be a higher completely dry rate with fewer subsequent tandem cuff additions with the perineal approach compared to the penoscrotal approach. This disparity may be explained by a more proximal artificial urinary sphincter cuff placement in the perineal group as evidenced by a larger cuff size.

Historical Review of Penile Prosthesis Design and Surgical Techniques: Part 1 of a Three-Part Review Series on Penile Prosthetic Surgery

INTRODUCTION Throughout history, many attempts to cure complete impotence have been recorded. Early attempts at a surgical approach involved the placement of rigid devices to support the natural process of erection formation. However, these early attempts placed the devices outside of the corpora cavernosa, with high rates of erosion and infection. Today, most urologists in the United States now place an inflatable penile prosthesis (IPP) with an antibiotic coating inside the tunica albuginea. AIM The article describes the key historical landmarks in penile prosthesis design and surgical techniques. METHODS The article reviews and evaluates the published literature for important contributions to penile prosthesis design and surgical techniques. MAIN OUTCOME MEASURES The article reviews and evaluates the historical landmarks in penile prosthesis design and surgical techniques that appear to improve outcomes and advance the field of prosthetic urology for the treatment of erectile dysfunction. Results. The current review demonstrates the stepwise progression starting with the use of stenting for achieving rigidity in the impotent patient. Modern advances were first used in war-injured patients which led to early implantation with foreign material. The design and techniques of penile prostheses placement have advanced such that now, more complications are linked to medical issues than failure of the implant. CONCLUSIONS Todays IPPs have high patient satisfaction rates with low mechanical failure rates.

North American Consensus Document on Infection of Penile Prostheses

OBJECTIVE To issue a consensus document on the prevention, management, and research of infection associated with penile prostheses, as neither professional associations nor governmental entities have issued guidelines that are specific to this infection. METHODS Sixteen North American experts on infection of penile prostheses were identified and assembled to select and discuss certain issues related to infection of penile prostheses. After performing an extensive search of clinically important issues in published reports, the 16 experts met twice in person to finalize the selection, discuss the issues that were deemed most important, and issue pertinent recommendations. RESULTS Although many subjects relevant to infection of penile prostheses were initially identified, the experts selected 10 issues as currently being the most important issues and for which there exists some support in the published data. The examined issues involved prevention, management, or research of infections associated with penile prostheses. CONCLUSION In the absence of pertinent guidelines, the consensus document issued by experts in the field of prosthetic urology is anticipated to improve the quality of patient care, streamline the prevention and management of infected penile prostheses, and stimulate collaborative research. Although this consensus document could serve as best practice recommendations, the lack of adherence to these recommendations would not indicate improper care.

Current Opinions on Alternative Reservoir Placement for Inflatable Penile Prosthesis among Members of the Sexual Medicine Society of North America

INTRODUCTION The Sexual Medicine Society of North America (SMSNA) includes as its members the most experienced prosthetic surgeons in North America who implant inflatable penile prostheses (IPPs). Obliteration of the space of Retzius (SOR) resulting from robotic-assisted laparoscopic prostatectomy (RALP) is a growing concern that has prompted many surgeons to look for alternative locations for reservoir placement during IPP implantation. AIM The aim of this article is to educate the community of prosthetic urologists about potential complications and alternative locations for IPP reservoir placement. METHODS A panel of high-volume experienced prosthetic surgeons discussed their views on alternative IPP reservoir implantation during a symposium focused on this topic. After reviewing reservoir complications, physician members of the SMSNA in attendance were surveyed using an audience response system (ARS) to facilitate sharing of knowledge, opinions, and recommendations related to reservoir implantation. MAIN OUTCOME MEASURES Six ARS questions were used to identify the percentages of SMSNA member physicians with concerns about traditional IPP reservoir placement and utilizing alternative reservoir placement (ARP), and the impact of changing practice patterns on patient safety. RESULTS A majority (81%) of experienced implant surgeons surveyed think that RALP sometimes or frequently makes traditional IPP reservoir placement more difficult. Placement of the reservoir in an alternative location is sometimes or frequently advantageous for patient safety. A vast majority (97%) of the 95 respondents indicated that ARP techniques should be included in physician training courses. CONCLUSIONS Physicians have concerns about reservoir placement in the SOR in RALP patients, which may explain why ARP is popular among SMSNA members. Device manufacturers should support physician training that provides for ARP. Clinical outcomes in RALP patients are needed to better understand the risks and benefits, and define the ideal location of reservoir placement in this population.

Physician and Patient Satisfaction with the New AMS 700 Momentary Squeeze Inflatable Penile Prosthesis

INTRODUCTION A single-armed, prospective, multicenter study evaluated the redesigned American Medical Systems (AMS) 700 Momentary Squeeze (MS) pump inflatable penile prosthesis (IPP) with enhanced features for ease of implantation and patient manipulation. The device incorporates design changes to all components: pump, cylinders, rear-tip extenders, and reservoir. AIM To assess physician and patient satisfaction with the new AMS 700 MS pump. METHODS Patients were selected from the existing population experiencing erectile dysfunction (ED) without previous prosthetic implantation. MAIN OUTCOME MEASURES Survey questionnaires were used to capture physician feedback on ease of implantation and patient education. Patient satisfaction with the device and existence of autoinflation were assayed. RESULTS Sixty-nine patients were implanted at seven U.S. sites. Mean age was 60.1 +/- 9.6 years. History of ED was >5 years in 34 (44.7%) patients. Main ED etiology was organic, nonspecific (32%). Eighty-four percent of the physicians felt proximal cylinder insertion was easier because of the smaller angle of cylinder input tubing and narrower base diameter. The new pump was felt easier to implant than the previous model by 57% of the physicians. The patients found the manipulation of the pump simple at device activation, with 96% easily locating the inflation bulb and 94% deflating the device with one push of the deflation button. Reviews were mixed among physicians concerning ease of training compared with the Tactile pump. Patient training was easier in 71%, harder in 21%, and same in 8%. Nevertheless, 67% of the patients were trained in 6 minutes or less. At 6 months, 77% of the patients were very satisfied, 9% somewhat satisfied, and 14% dissatisfied. Autoinflation occurred in two patients (3%). CONCLUSION The new AMS 700 MS IPP seems a distinct improvement over previous devices with most physicians feeling implantation and patient instruction were easier. The device also satisfied 86% of the users and virtually eliminated autoinflation.

Severe Vascular Complication after Implantation of a Three-Piece Inflatable Penile Prosthesis

We report a case of acute arterial ischemia and deep venous thrombosis due to compression of the external iliac vein and artery by the reservoir of a three-piece inflatable penile prosthesis.