Effect of 0.05% chlorhexidine gluconate in water on the hydrophilic inflatable penile prosthesis: biocompatibility, adherence, and dip time.

BACKGROUND: Rates of infection after inflatable penile prosthesis range from 1% to 3%; however, a new surgical irrigation solution is Food and Drug Administration cleared as antimicrobial wound lavage and appears to be safe for patients and noncaustic during hydrophilic inflatable penile prosthesis (hIPP) dipping and irrigation. AIM: To evaluate if 0.05% chlorhexidine (CHG) lavage is caustic to the hIPP coating and if dip adherence is dependent on time. METHODS: Preconnected hIPP devices were tested at a Coloplast research and development laboratory. The devices were soaked in the 0.05% CHG lavage solution or normal saline for 1, 15, 30, and 60 minutes. Subsequently, all parts were dried for 15 minutes in a 35 °C oven. A Congo red dye test was performed following a Coloplast-validated and Food and Drug Administration-cleared test method to ensure product reliability. Implants were then visually inspected for deleterious effects as well as dip coverage. In addition, we evaluated 0.05% CHG lavage solution vs previously published hIPP dipping solutions. OUTCOMES: 0.05% CHG lavage does not appear to damage the hIPP coating, and adherence of this solution is not dependent on dip time. RESULTS: All components of the preconnected hydrophilic IPPs were tested for coating adherence and defects. All tested IPPs achieved a "satisfactory" coating, meaning a uniform coat without flaking or clumping. Furthermore, there were no noticeable caustic effects or differences in coating adherence between the normal saline-soaked control and 0.05% CHG-coated arms with increasing dip time. A review of the literature for 0.05% CHG lavage solutions vs previously published hIPP dipping solutions revealed that it may have some advantages over previously reported antibiotic solutions. CLINICAL IMPLICATIONS: This study serves as a foundation to introduce 0.05% CHG lavage to the urologic literature as a potentially new "magic bullet" irrigation. STRENGTHS AND LIMITATIONS: Major strengths of the study are that it is the first study of its kind to address the question of what dip duration should be used and whether it is scientifically reproducible. A limitation is the in vitro model, thus needing validation in a clinical setting. CONCLUSION: 0.05% CHG does not appear to negatively affect the hIPP coating or differ in adherence with increasing dip time; however, long-term device performance has not been verified.

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.

Simulation Training in Penile Implant Surgery: Assessment of Surgical Confidence and Knowledge With Cadaveric Laboratory Training.

INTRODUCTION: Constraints on surgical resident training (work-hour mandates, shorter training programs, etc.) and availability of expert surgical educators may limit the acquisition of prosthetic surgical skills. As a result, training courses are being conducted to augment the prosthetic surgery learning experience. AIM: To evaluate the impact of a hands-on cadaver-based teaching program on resident procedural knowledge and procedural confidence with placement of a penile prosthesis. MAIN OUTCOME MEASURE: Changes in procedural knowledge and self-confidence following a focused training program on penile prosthetics. METHODS: As part of the 2017 Society of Urologic Prosthetic Surgeons and the Sexual Medicine Society of North America Annual Meeting, 31 urology residents participated in a simulation lab in prosthetic urology. The lab included didactic lectures and a hands-on cadaveric laboratory. Participants completed surveys before and after the course. Wilcoxon Signed Rank tests for matched pairs were used to compare respondents' pre- and postcourse knowledge (% questions answered correctly) and confidence ratings. Prior implant experience was assessed. RESULTS: 31 residents participated in this study. The majority of the participants were 4th- (41.9%) and 5th-year residents (38.7%). Participants showed a significant improvement in procedural knowledge test scores (68.8±13.4 vs 74.2 ± 13.0, P < .05) and self-reported increased median surgical confidence levels (4 vs 3, P value < .001) after completion of the cadaveric course. Subgroup analysis demonstrated that residents with prosthetic surgery experience of <10 cases benefited the most. In addition, improvement in surgical confidence levels observed was greater than the improvement in surgical knowledge. The overall cost of the simulation training course was approximately $1,483 per resident. CONCLUSION: Simulation training in prosthetic surgery seems to improve surgical confidence and knowledge. Further research is needed to better understand the benefits and limitations of simulation training. Lentz AC, Rodríguez D, Davis LG. Simulation training in penile implant surgery: Assessment of surgical confidence and knowledge with cadaveric laboratory training. Sex Med 2018;6:332-338.

Penile Prosthesis Implantation in Patients With Peyronie's Disease: Results of the PROPPER Study Demonstrates a Decrease in Patient-Reported Depression.

BACKGROUND: Although there is a strong correlation between erectile dysfunction and Peyronie's disease (PD), there are limited data on the efficacy and satisfaction of inflatable penile prosthesis (IPP) placement in this population. AIM: To assess the efficacy and overall satisfaction of IPP placement in men with erectile dysfunction and concomitant PD using the Prospective Registry of Outcomes with Penile Prosthesis for Erectile Restoration (PROPPER). METHODS: Data from the PROPPER study were examined to determine patient baseline characteristics and primary and secondary etiologies before IPP treatment and included type and size of implant received, presence of corporal fibrosis, and operative time. Men completed 5 validated questionnaires at baseline and annually out to 5 years. OUTCOMES: IPP placement was performed in 250 patients with PD with comparable surgical times and outcomes as in patients without PD. RESULTS: 1,180 men underwent IPP insertion at 11 sites; of these, 250 (21.2%) were diagnosed with PD. This is an ongoing study; 1- and 2-year data are available for 177 (70.8%) and 130 (52.0%) patients, respectively. Intraoperatively, 51.2% patients with PD had corporal fibrosis, with an average operative time of 52.8 minutes. At baseline, 19.3% of men (36 of 187) with PD reported being depressed, with a decrease to 10.5% (6 of 57; P = .02) and 10.9% (5 of 46; P = .07) at 1- and 2-year follow-ups, respectively. More than 80% of patients with PD were satisfied or very satisfied at 1- and 2-year follow-ups. In addition, more than 88% of patients with PD were using their device at the 1- and 2-year follow-up visits. CLINICAL IMPLICATIONS: Patients with concomitant PD and erectile dysfunction can safely and effectively have an IPP placed with similar outcomes as patients without PD. STRENGTHS AND LIMITATIONS: The 1st limitation was that all participating prosthetic urologists were high-volume implanters and these results might not be representative of those of general urologists. A 2nd limitation was that none of the patients were randomized. A 3rd limitation was that although most study points were mandatory, some of the data collection, including depression data, was optional, with not all sites participating. A 4th limitation was that depression data were self-reported. CONCLUSION: IPP can be inserted in patients with PD with acceptable patient satisfaction and usage and depressive symptoms appear to lessen in patients with PD after IPP placement. Khera M, Bella A, Karpman E, et al. Penile Prosthesis Implantation in Patients With Peyronie's Disease: Results of the PROPPER Study Demonstrates a Decrease in Patient-Reported Depression. J Sex Med 2018;15:786-788.

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.

Inflatable penile prosthesis implant length with baseline characteristic correlations: preliminary analysis of the PROPPER study.

BACKGROUND: "Prospective Registry of Outcomes with Penile Prosthesis for Erectile Restoration" (PROPPER) is a large, multi-institutional, prospective clinical study to collect, analyze, and report real-world outcomes for men implanted with penile prosthetic devices. We prospectively correlated co-morbid conditions and demographic data with implanted penile prosthesis size to enable clinicians to better predict implanted penis size following penile implantation. We present many new data points for the first time in the literature and postulate that radical prostatectomy (RP) is negatively correlated with penile corporal length. METHODS: Patient demographics, medical history, baseline characteristics and surgical details were compiled prospectively. Pearson correlation coefficient was generated for the correlation between demographic, etiology of ED, duration of ED, co-morbid conditions, pre-operative penile length (flaccid and stretched) and length of implanted penile prosthesis. Multivariate analysis was performed to define predictors of implanted prosthesis length. RESULTS: From June 2011 to June 2017, 1,135 men underwent primary implantation of penile prosthesis at a total of 11 study sites. Malleable (Spectra), 2-piece Ambicor, and 3-piece AMS 700 CX/LGX were included in the analysis. The most common patient comorbidities were CV disease (26.1%), DM (11.1%), and PD (12.4%). Primary etiology of ED: RP (27.4%), DM (20.3%), CVD (18.0%), PD (10.3%), and Priapism (1.4%), others (22.6%). Mean duration of ED is 6.2¡À4.1 years. Implant length was weakly negatively correlated with White/Caucasian (r=-0.18; P<0.01), history of RP (r=-0.13; P<0.01), PD as comorbidity (r=-0.16; P<0.01), venous leak (r=-0.08; P<0.01), and presence of stress incontinence (r=-0.13; P<0.01). Analyses showed weak positive correlations with Black/AA (r=0.32; P<0.01), CV disease as primary ED etiology (r=0.08; P<0.01) and pre-operative stretched penile length (r=0.18; P<0.01). There is a moderate correlation with pre-operative flaccid penile length (r=0.30; P<0.01). CONCLUSIONS: Implanted penile prosthesis length is negatively correlated with some ethnic groups, prostatectomy, and incontinence. Positive correlates include CV disease, preoperative stretched penile length, and flaccid penile length.

The Who, How and What of Real-World Penile Implantation in 2015: The PROPPER Registry Baseline Data.

PURPOSE: To date, the published data on patients treated with penile implantation generally consist of small series of single surgeon, retrospective experiences rather than prospective or large, multicenter evaluations. This study establishes a baseline of data collection from the PROPPER (Prospective Registry of Outcomes with Penile Prosthesis for Erectile Restoration). The PROPPER is the first large, prospective, multicenter, multinational, monitored, and internal review board approved study of real-world outcomes for patients with penile implants. MATERIALS AND METHODS: Data from the PROPPER study were examined to determine patient baseline characteristics and primary and secondary etiologies before treatment of erectile dysfunction. Data include type and size of implant received, surgical steps/techniques used during implantation, and duration of hospital stay. RESULTS: Through April 2, 2015 a total of 1,019 patients were enrolled in the study at 11 sites, with radical prostatectomy being the predominant etiology in 285 (28%). Of those 285 patients treated with radical prostatectomy 280 (98.2%) received an AMS 700™. Of these patients 65.0% (182 of 280) had placement of the reservoir in the traditional retropubic space vs 31.8% (89 of 280) in a submuscular location. Of those patients not treated with radical prostatectomy receiving an AMS 700, fewer underwent reservoir placement in the submuscular location (17.7%, 124 of 702, vs 80.9%, 568 of 702; p <0.001). Of those patients receiving an AMS 700, those treated with radical prostatectomy and those with diabetes had more outpatient admissions (less than 24 hours, 56.8% and 52.1%, respectively) compared to those with cardiovascular disease and Peyronie's disease (42.0% and 35.6%, respectively, p <0.001). CONCLUSIONS: This first-of-its-kind, large, prospective, multicenter study reveals most penile implant cases in North America receive an inflatable penile prosthesis and that radical prostatectomy is the most common primary etiology of penile implant surgery. Moreover, patients treated with radical prostatectomy were more likely to have the reservoir placed in a submuscular location, have a longer operating room time and be admitted to the hospital overnight compared with other patient groups.

Technological Improvements in Three-Piece Inflatable Penile Prosthesis Design over the Past 40 Years.

INTRODUCTION: The advent of the penile prosthesis revolutionized the treatment of erectile dysfunction (ED), resulting in near-complete treatment efficacy and high patient satisfaction rates. While several types of penile prosthesis are available, the inflatable penile prosthesis (IPP) is the most commonly used device in the United States. AIMS: To describe the key modifications to IPPs from the two major manufacturers-American Medical Systems (AMS) and Coloplast-since the invention of the IPP, and to relate these changes to improvements in prosthesis function and patient outcomes based on available literature. METHODS: Review and evaluation of the literature between 1973 and present describing modifications in IPP design and the influence of these modifications on IPP durability and patient-related factors. MAIN OUTCOME MEASURES: Data describing the impact of iterative improvements in three-piece IPP design on device function, durability, and patient outcomes. RESULTS: There were progressive improvements in IPP technology from both major manufacturers not only on the durability of the prosthesis but also on patient outcomes, with fewer device failures and lower infection rates. Notable improvements include incorporation of kink-resistant tubing, changes in the weave or addition of shear- and infection-resistant coatings to cylinder layers, pump and tubing connection modifications, the addition of rear tip extenders, and the incorporation of lockout valves to prevent autoinflation. CONCLUSIONS: Numerous incremental modifications to the IPP from both major manufacturers since its invention have increased its durability and improved patient outcomes.

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.

A guide for inflatable penile prosthesis reservoir placement: pertinent anatomical measurements of the retropubic space.

INTRODUCTION: The primary concern for many prosthetic urologic surgeons in placing the three-piece inflatable penile prosthesis (IPP) is the concept of "blind reservoir placement." Extensive reports permeate the literature regarding bladder, bowel, vascular, and various hernial complications occurring while attempting to place the reservoir into the retropubic space. However, despite these widely documented complications, there is a paucity of published literature on surgically pertinent anatomical measurements of the retropubic space relating to reservoir placement. The focus of this project was to evaluate the special relationships and anatomical measurements of the retropubic space to better aid the surgeon in the safe placement of the reservoir. AIM: Analyses of the spatial measurements of reservoir placement into the retropubic space with a focus on utilizing a penoscrotal approach were conducted. In addition, we reviewed and evaluated the published literature for important contributions surrounding the various surgical techniques during placement of a penile prosthesis reservoir. METHODS: Cadaveric pelvic specimens were dissected to determine the distance and angulation (in degrees) from the inguinal ring to several critical anatomic structures in the pelvis. This format was utilized to simulate the basic features of reservoir placement into the classic retropubic space. We also reviewed and evaluated the published literature for important contributions describing the various surgical techniques in the placement of penile prosthesis reservoirs into the retropubic space. MAIN OUTCOME MEASURES: Anatomic measurements were obtained from the inguinal ring to the bladder, external iliac vein, and superior origin of the dorsal suspensory ligament at the anterior apex of the pendulous penis. The angle was measured from the inguinal ring to these structures and recorded. We also reviewed the published literature for various penoscrotal IPP surgical techniques involving placement of the reservoir into the retropubic space to further supplement the pertinent spatial relationships data acquired in this study. RESULTS: Of the 28 cadavers, 3 were excluded because of signs of major pelvic surgery, and an additional 6 sides were excluded because of unilateral fibrosis/surgery or difficulty in exposure. Distance to the decompressed bladder was 5-8 cm (average 6.45 cm) at a 15-30 (22.8) degrees medial measurement from the inguinal ring. The filled bladder was 2-4 cm (average 2.61 cm) from the inguinal ring. The external iliac vein distance from the inguinal ring was 2.5-4 cm (average 3.23 cm) at a 20-60 (36.4) degrees lateral measurement from the inguinal ring. Heretofore, the published literature does not appear to have detailed measurements that are provided in this study. CONCLUSIONS: These anatomical measurements of the retropubic space demonstrate the importance of decompressing the bladder and avoiding deep dissection lateral to the inguinal ring, as the external iliac vein is much closer than currently espoused. We feel that these data are significant to the surgeon proceeding with reservoir placement during IPP surgery.

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.

Prospective evaluation of patient satisfaction, and surgeon and patient trainer assessment of the Coloplast titan one touch release three-piece inflatable penile prosthesis.

INTRODUCTION: A single-armed, prospective, multicenter international study evaluated the redesigned Coloplast Titan One Touch Release (OTR) pump inflatable penile prosthesis. The OTR pump has a unique release valve that permits deflation of the implant with one squeeze of opposing touch pads. AIMS: To assess the impact of a new penile prosthesis design, the Titan OTR, on patient ease of operation. Furthermore, to assess patient satisfaction, surgeon acceptance, and the ease with which patients were trained in device operation in the clinic setting. METHODS: A total of 113 eligible patients from eight centers were recruited from men presenting with erectile dysfunction without prior prosthetic implantation. The subjects had a mean age of 61 years, and had a number of comorbidities, including diabetes (31.9%), hypertension (34.5%), and Peyronie's disease (23.9%). All underwent implantation of the study device. MAIN OUTCOME MEASURES: Questionnaires were used to capture patient satisfaction as well as physician feedback on ease of implantation and patient education. A paired analysis was completed for patient satisfaction at 6 (N = 96) and 12 (N = 90) months. RESULTS: Overall satisfaction with the device was 90.6% and 90.0% at 6 and 12 months, respectively. The primary end point, ease of deflation, was seen in 70.8% and 73.3% at these two time points, with the 12-month value statistically better than historical controls. Physicians overwhelmingly reported straightforward/simple intraoperative product preparation (97.3%) and equivalent or easier training compared with their previous pump of choice (96.4%). Adverse events for all subjects (N = 113) included removal of the device in four cases (3.5%) for infection and one case for chronic pain (0.8%). CONCLUSIONS: The Titan OTR represents an advance in penile prosthetic technology that is well accepted by patients and physicians. The study design allowed for realistic evaluation of the new technology aimed at enhancing clinical outcomes.

Outcomes of and satisfaction with the inflatable penile prosthesis in the elderly male.

Objective. To determine the outcomes of and satisfaction with the multi-component inflatable penile prosthesis (IPP) in the elderly male (age >71). Methods. Using a chart review and telephone survey, we retrospectively assessed patients who underwent IPP or combined IPP/artificial urinary sphincter (AUS) from 2004-2006. Results. We identified 56 patients that underwent IPP (48) or IPP/AUS (8). The age range was 71-86 (mean 74.3) at the time of surgery, with a follow-up range of 0.5-2.4 years (mean 1.5). The overall complication rate was 3.8% (2 of 56) with one device removed for infection and a second patient requiring exploration for a postoperative hematoma. The telephone interview was conducted with 35 of 56 patients. Patients rated ease of use (a scale from 1-5, 5 meaning very easy) and overall satisfaction (a scale of 1-5, 5 meaning very satisfied) at an average of 4.1 and 4.3, respectively. IPP usage varied from 0-7 times per month (mean 3.3). 32 of 35 patients (91%) said they would undergo the procedure again. Conclusion. Our review demonstrates that the IPP is well tolerated in the elderly male population, who report a high degree of satisfaction and ease of use with this device.

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.