Impact of Radiation and Transcorporeal Artificial Sphincter Placement in Patients with Prior Urethral Cuff Erosion: Results from a Retrospective Multicenter Analysis.

PURPOSE: Many providers elect to use a transcorporeal approach for artificial urinary sphincter placement in an attempt to minimize risks, given the increased risk of complications in revision cases. We present outcomes in a multicenter retrospective analysis of artificial urinary sphincter cuff reimplantation in patients with prior cuff erosion with special consideration given to the transcorporeal approach. MATERIALS AND METHODS: We compiled a multi-institutional database of patients who underwent artificial urinary sphincter reimplantation after prior urethral erosion. Of the 34 identified patients 24 underwent transcorporeal cuff replacement. Patients with transcorporeal cuff replacement were further analyzed with specific stratification for radiation therapy. RESULTS: The rate of subsequent complications after eroded cuff reimplantation was 32.4% (11 of 34 patients). The most frequent complication was recurrent erosion, which developed in 9 of the 34 patients (26.4%). Repeat artificial urinary sphincter complications developed more frequently in patients with history of radiation compared to nonirradiated patients (8 of 16 or 50% vs 3 of 18 or 16.7%). However, this difference was not statistically significant (p = 0.066). The transcorporeal technique was applied in 24 of 33 patients (70.5%) and relative to the nontranscorporeal group there was no difference in the complication rate (p = 0.438). On subgroup analysis of the transcorporeal group there was a higher rate of repeat complications in irradiated patients (p = 0.006). CONCLUSIONS: These data suggest that transcorporeal cuff reimplantation may not decrease the incidence of repeat complications after prior cuff erosion. However, radiation therapy is associated with a worse outcome even when transcorporeal cuff placement is performed.

Prior Radiation Therapy Decreases Time to Idiopathic Erosion of Artificial Urinary Sphincter: A Multi-Institutional Analysis.

PURPOSE: Substantial controversy and conflicting data exist regarding the survival of the artificial urinary sphincter in patients with prior radiation therapy. We present data from a multi-institutional analysis examining the effect of prior radiation for prostate cancer on device survival. MATERIALS AND METHODS: A database was compiled of patients with artificial urinary sphincter cuff erosion, which included demographic and comorbid patient characteristics, functional analyses and interventions. We identified 80 patients with iatrogenic or idiopathic artificial urinary sphincter erosion. Idiopathic erosion cases were further analyzed to determine factors influencing device survival with specific stratification for radiation therapy. RESULTS: A total of 56 patients were identified with idiopathic artificial urinary sphincter erosion. Of those men 33 (58.9%) had not undergone radiation treatment while 23 (41.1%) had a history of brachytherapy or external beam radiotherapy. In patients without radiation erosion-free median device survival was 3.15 years (95% CI 1.95-5.80), in contrast to the median device survival of only 1.00 year (95% CI 0.36-3.00) in irradiated patients. The erosion-free survival experience of patients with vs without radiation differed significantly (Wilcoxon-Breslow test for equality of survivor functions p = 0.03). CONCLUSIONS: Radiation therapy in patients with known idiopathic cuff erosion in this contemporary analysis correlated with significantly increased time to erosion. Mean time to idiopathic cuff erosion was accelerated by approximately 2 years in irradiated cases. To our knowledge these data represent the first demonstration of substantial outcome differences associated with radiation in patients with an artificial urinary sphincter who present specifically with cuff erosion.

Urethral Stricture Outcomes After Artificial Urinary Sphincter Cuff Erosion: Results From a Multicenter Retrospective Analysis.

OBJECTIVE: To evaluate the influence of both repair type and degree of cuff erosion on postoperative urethral stricture rate. Sparse literature exists regarding patient outcomes after artificial urinary sphincter (AUS) cuff erosion. Surgeons from 6 high-volume male continence centers compiled a comprehensive database of post-erosion patients to examine outcomes. MATERIALS AND METHODS: This retrospective multi-institution study included 80 patients treated for AUS cuff erosions. Seventy-eight patients had specific information regarding post-cuff erosion urethral strictures. Erosion patients were categorized into 1 of 3 repair types at the time of explant surgery: catheter only, single-layer capsule-to-capsule repair (urethrorrhaphy), and formal urethroplasty. Operative notes and available medical records were extensively reviewed to collect study data. RESULTS: Twenty-five of 78 patients manifested a urethral stricture after AUS cuff erosion (32%). More strictures occurred among patients who underwent urethrorrhaphy (40% vs 29% for catheter only and 14% for urethroplasty). Stricture rates did not vary significantly by repair type (P = .2). Strictures occurred significantly more frequently in patients with complete cuff erosions (58%) as compared to partial erosions (25%, P = .037). A trend was detected regarding increased percentage of erosion correlating with increased stricture rate, but this did not reach statistical significance (P = .057). Partially eroded patients were more likely to undergo urethrorrhaphy repair (60%, P = .002). CONCLUSION: Urethral stricture was more likely to occur after complete cuff erosion as opposed to partial erosion in this multicenter retrospective population. Repair type, whether catheter only, urethrorrhaphy, or formal urethroplasty, did not appear to influence postoperative stricture rate.

Reservoir alternate surgical implantation technique: preliminary outcomes of initial PROPPER study of low profile or spherical reservoir implantation in submuscular location or traditional prevesical space.

PURPOSE: Alternative reservoir site placement has become an accepted technique for patients who require an inflatable penile prosthesis. To our knowledge there has been no prospective evaluation of this technique, which is currently off label. We performed a prospective, multicenter, multinational, internal review board approved study to evaluate the effectiveness and safety of alternative reservoir site placement. MATERIALS AND METHODS: PROPPER initiated in June 2011, is a database containing patient outcomes of inflatable penile prosthesis implantation. Patients with AMS® penile prostheses continue to be enrolled at 13 North American sites. We examined PROPPER study data to determine surgical implantation use patterns for the AMS 700™ series. We evaluated reservoir implantation site and complications by implantation site. RESULTS: A total of 759 patients had been implanted with an AMS 700 series implant by the time of evaluation. Mean patient followup was 17.8 months (range 0 to 36). There was no reported case of revision surgery for a palpable reservoir and no report of vascular or hollow viscous injury associated with alternative reservoir site placement. Two cases of reservoir herniation in the alternative reservoir site placement group and 2 in the space of Retzius group were treated with reservoir reimplantation. Patients with 1-year assessment available were satisfied or very satisfied with the device and reported a frequency of use of more than once per month. CONCLUSIONS: Alternative reservoir placement in the submuscular location is an option in patients who undergo inflatable penile prosthesis surgery. Implant surgeons should consider alternative reservoir site placement a safe, effective alternative to reservoir placement in the space of Retzius.

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.

Avanafil for the treatment of erectile dysfunction: a multicenter, randomized, double-blind study in men with diabetes mellitus.

OBJECTIVE: To prospectively assess the safety and effectiveness of the investigational phosphodiesterase 5 inhibitor avanafil to treat erectile dysfunction in men with diabetes mellitus. PATIENTS AND METHODS: This 12-week, multicenter, double-blind, placebo-controlled study conducted between December 15, 2008, and February 11, 2010, randomized 390 men with diabetes and erectile dysfunction 1:1:1 to receive avanafil, 100 mg (n=129), avanafil, 200 mg (n=131), or placebo (n=130). Coprimary end points assessed changes in the percentage of sexual attempts in which men were able to maintain an erection of sufficient duration to have successful intercourse (Sexual Encounter Profile [SEP] 3), percentage of sexual attempts in which men were able to insert the penis into the partner's vagina (SEP 2), and International Index of Erectile Function erectile function domain score. RESULTS: Compared with placebo, least-squares mean change from baseline to study end in SEP 3, SEP 2, and International Index of Erectile Function erectile function domain score were significantly improved with both avanafil, 100 mg (P≤.002), and avanafil, 200 mg (P<.001). Additional analyses indicated that successful intercourse could be initiated in 15 minutes or less through more than 6 hours after avanafil dosing. Adverse events most commonly reported with avanafil treatment were headache, nasopharyngitis, flushing, and sinus congestion. CONCLUSION: Avanafil was safe and effective for treating erectile dysfunction in men with diabetes and was effective as early as 15 minutes and more than 6 hours after dosing. The adverse events seen with avanafil were similar to those seen with other phosphodiesterase 5 inhibitors. TRIAL REGISTRATION: clinicaltrials.gov Identifier NCT00809471.

A randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of avanafil in subjects with erectile dysfunction.

INTRODUCTION: Phosphodiesterase type 5 (PDE5) inhibitors have become standard treatment for erectile dysfunction (ED). AIM: To prospectively evaluate the safety and efficacy of avanafil, a novel PDE5 inhibitor, in men with mild to severe ED. METHODS: In this multicenter, double-blind, Phase 3 trial, 646 subjects were randomized to receive avanafil (50 mg, 100 mg, 200 mg) or placebo throughout a 12-week treatment period. Subjects were instructed to take study drug 30 minutes prior to initiation of sexual activity. At least a 12-hour separation time between doses was required; no restrictions were placed on food or alcohol intake. MAIN OUTCOME MEASURES: Improvement in erectile function (EF) was measured by Sexual Encounter Profile questions 2 and 3 (SEP2 and SEP3) and by the EF domain of the International Index of Erectile Function (IIEF) questionnaire. RESULTS: Mean change in percentage of successful sexual attempts (SEP2 and SEP3) and IIEF-EF domain score significantly favored all doses of avanafil over placebo (P ≤ 0.001). Secondary analyses demonstrated achievement of successful intercourse by subjects within 15 minutes of dosing. Of the 300 sexual attempts made during this interval, 64% to 71% were successful in avanafil-treated subjects compared with 27% in placebo-treated subjects. Successful intercourse was also demonstrated >6 hours post dosing, with 59% to 83% of the 80 sexual attempts successful in avanafil-treated subjects compared with 25% of placebo-treated subjects. The most commonly reported adverse events in subjects taking avanafil included headache, flushing, and nasal congestion; there were no drug-related serious adverse events. CONCLUSION: Following 12 weeks of avanafil treatment without food or alcohol restrictions, significant improvements in sexual function were observed with all 3 doses of avanafil compared with placebo. Successful intercourse was observed as early as 15 minutes and >6 hours after dosing in some subjects. Avanafil was generally well tolerated for the treatment of ED.

Effect of sildenafil citrate on the male sexual experience assessed with the Sexual Experience Questionnaire: a multicenter, double-blind, placebo-controlled trial with open-label extension.

INTRODUCTION: The Sexual Experience Questionnaire (SEX-Q) enables quick and easy assessment of functional, emotional, and satisfaction-related aspects of the sexual experience in men with erectile dysfunction (ED). AIM: To assess correlations between improvement on the SEX-Q and outcomes on other validated questionnaires. METHODS. Men with ED (score < or =25 on the Erectile Function domain of the International Index of Erectile Function [IIEF]) who had used less than or equal to six doses of any phosphodiesterase 5 inhibitor (none within 6 months) were randomized to 10 weeks of double-blind, placebo-controlled (DBPC) flexible-dose sildenafil citrate (50 or 100 mg, as needed), followed by 6 weeks of open-label (OL) sildenafil. MAIN OUTCOME MEASURES: SEX-Q, IIEF, Quality of Erection Questionnaire (QEQ), Self-Esteem and Relationship (SEAR) Questionnaire, Erection Hardness Score (EHS), successful intercourse attempts (SIAs), Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), and global efficacy questions (GEQs). RESULTS: Compared with the placebo group (N = 105), the sildenafil group (N = 104) at DBPC end of treatment (EOT) had significantly more improvement (P < 0.05) on all SEX-Q, IIEF (except the Sexual Desire domain), QEQ, and SEAR outcomes, more frequent SIAs and EHS 3 (hard enough for penetration but not completely hard) or EHS 4 (completely hard) erections (odds ratio [OR], 2.52 and 3.46, respectively), EHS 4 erections four times as often (OR, 6.41), more men satisfied with treatment (EDITS; OR, 2.6), approximately twice as many men with improved erections (GEQ1; OR, 5.8) and ability to have sexual intercourse (GEQ2; OR, 5.4), and GEQ3 scores that indicated better sex (P < 0.0001). SEX-Q score improvements correlated positively with all other outcomes. At OL EOT, most outcomes were >60% (and approximately half were > or =80%) of the maximum positive result. CONCLUSIONS: SEX-Q change scores correlate with several other functional, emotional, and satisfaction-related outcomes in men treated with sildenafil for ED, allowing a simple and focused evaluation of the sexual experience.

Patient satisfaction after dual implantation of inflatable penile and artificial urinary sphincter prostheses.

OBJECTIVES: Since description of the transverse scrotal approach for artificial urinary sphincter (AUS) placement, simultaneous implantation of an inflatable penile prosthesis (IPP) and AUS through a single incision has been shown to constitute safe, efficient, and cost-effective treatment for men plagued by both erectile dysfunction and urinary incontinence. We present patient satisfaction outcomes after simultaneous dual implantation (DI) of an IPP and AUS. METHODS: We compared outcomes of postprostatectomy patients who underwent DI to those receiving IPP or AUS alone from 2001 to 2006. Telephone interviews using a standard questionnaire were conducted to evaluate prosthetic functionality, ease of use, and patient satisfaction. RESULTS: A total of 95 men were evaluated (31 for IPP alone, 31 for AUS alone, and 33 for DI). Daily pad usage decreased from 4.6 to 0.8 pads per day with AUS alone and 6.1 to 1.3 pads per day with DI. Patients were similarly satisfied with IPP rigidity during inflation and flaccidity during inactivation in both IPP and DI groups (4.1 to 4.4 for rigidity and 3.9 for flaccidity [1 = "unhappy" and 5 = "happy"]). Ease of scrotal pump operation was similar in all groups, as was overall prosthetic satisfaction. Most patients stated that they would recommend the DI procedure to a friend or relative (87% to 94%) or have the procedure done again (77% to 94%). CONCLUSIONS: Dual implantation produces encouraging outcomes in patient satisfaction, ease of use and functionality that are similar to those found after placement of either IPP or AUS alone.

Minority issues in prostate disease.

This article has discussed the increased incidence and disproportionately increased mortality of prostate cancer among African American men.Although the exact reasons are unknown, genetics may play a role, in addition to health care practices. Morbidity from other disease states, such as diabetes, obesity, or hypertension, may influence the overall survival of patients with prostate cancer. Current research tools will continue to explore biologic differences between the races; however, socioeconomic status and access to health care must not be overlooked. Several studies have demonstrated that similar disease stages and equal access to health care will result in similar outcomes. It is recognized that screening for prostate cancer will remain a controversial topic. Several influential professional societies recommend against screening and other professional societies endorse screening. Large-scale trials are currently underway hoping to answer this critical question. Since the advent of current screening tools, however, it seems that the overall mortality for prostate cancer has decreased and this cannot be ignored. Certainly, screening programs and clinical trials have traditionally had difficulty in recruiting minority participants, although more recent trials seem to be finding success. A primary care physician who is viewed as competent by their patients can certainly have a positive impact on their African American patients' willingness to participate in studies and screening programs. Most importantly, on the individual level, primary care physicians can provide a great service to their minority patients by offering educational materials on prostate cancer and by offering screening to qualified patients. The current American Urologic Association and National Cancer Institute guidelines recommend offering screening to all men age 50 and above. African American men or men with a first-degree relative with prostate cancer should be offered screening beginning at age 40. Proper screening consists of both a digital rectal examination to assess for asymmetry or nodules of the prostate and a serum PSA. Current recommendations are that individuals with a serum PSA greater than 4 ng/mL ora prostate nodule or asymmetric prostate should be referred to an urologist,where a biopsy can be performed easily in the office setting.The PSA cutoff of 4 has recently been questioned. A study by Thompson et al [31] evaluated 2950 men with a PSA of 4 or less with prostate biopsy.They found that the risk of prostate cancer in men with a PSA between 3.1 and 4 was 26.9% and that 25% of these men with prostate cancer had high-grade disease. All men found to have cancer had T1 disease. The clinical relevance of this surprisingly high rate of prostate cancer in men with a normal PSA is yet to be determined and is pending in studies on the ultimate effect of screening on mortality from prostate cancer. This information is not intended to confuse the issue, but intended to provide the most up-to-date information and allow for the best clinical decision making by the primary care physician. What can currently be recommended is if a patient is concerned about his possibility of having prostate cancer despite a normal PSA, a referral to an urologist to at least further discuss the issue may be in order. This may be especially true if the patient is African American or has a family history of prostate cancer at an early age.

Cost and time benefits of dual implantation of inflatable penile and artificial urinary sphincter prosthetics by single incision.

OBJECTIVES: To evaluate the efficiency, safety, and cost-effectiveness of synchronous prosthetic treatment of male urinary incontinence and impotence using a single transverse scrotal incision. METHODS: A total of 92 inflatable penile prostheses (IPPs), 21 artificial urinary sphincters (AUSs), and 15 combined IPPs/AUSs were implanted in 128 men at Brooke Army Medical Center and the University of Texas Health Science Center at San Antonio. The operative times and outcomes were compared among three groups (group 1, IPP; group 2, AUS; and group 3, dual IPP/AUS). We performed cost estimates of synchronous versus two-stage implant procedures. RESULTS: Dual implantation in a single-stage procedure significantly reduced (24.7%) the operative time (P <0.05, mean 113 minutes) compared with the total time for the individual procedures (IPP, average of 78 minutes; AUS, average of 72 minutes; total 150 minutes). No prosthetic infections or erosions occurred in this series. Dual implantation was associated with approximately a $7000 cost savings compared with individual procedures. CONCLUSIONS: The results of our study have shown that dual prosthetic implantation through a single incision is safe, efficient, and cost-effective.