Citations

Abstract Introduction The optimal irrigation solution with inflatable penile prosthesis (IPP) remains controversial. Objective We sought to determine the impact of the type of fluid used for dipping and irrigation (D&I) on the risk of IPP infections. Methods This is a retrospective, consecutive cohort study that includes individuals who underwent initial Coloplast IPP insertion or revision between January 2021 and May 2024. Cases done from January 2021 to August 2022 (20 months) underwent Rifampin/Gentamycin for dipping and Vancomycin/Gentamycin for irrigation (Group 1), whereas those from October 2022 to May 2024 (20 months) utilized 0.05% chlorhexidine gluconate for both D & I (Group 2). Surgeon, operative time, age, diabetes mellitus (DM), perioperative level of HbA1C, history of acute urinary retention (AUR), positive urine culture, and oral antibiotic (AB) regimen at discharge were obtained. The rate of infection between the two study groups and the association of risk factors with developing infection were explored by t-test and chi-square analysis for continuous and discrete variables, respectively. P-value less than 0.05 was considered statistically significant. Results In comparison of two study groups, infection rate was significantly higher in group 2 at 2.5% (8/314) than group 1 which did not have any infection (0/280) (P = 0.008). There was no significant association between the study group and operative time (P = 0.45), DM (P = 0.29), HbA1C level (P = 0.20) and AUR (P = 0.87) or surgeon (Table 1). Notably, two clinical infections were from non-virulent organisms (Streptococcus Constellatus & Staphylococcus Lugdunensis). Two of three patients undergoing malleable salvage failed. Since no infection was observed in group1, infection risk predictors were only analyzed in group 2. The patients in group 2 were stratified based on their diabetes mellitus (DM) status, and analyses were conducted to investigate the effect of a positive DM history on the risk of infection. The results indicated that having DM significantly increased the risk of infection, with 75% (6/8) of patients with DM developing an infection compared to 26% (78/306) of those without DM (P = 0.006) (Table 2). Notably, three of eight infections occurred in patients discharged on Augmentin or cefdinir secondary to drug interaction warning (our typical post op prophylaxis is Bactrim or ciprofloxacin). Conclusions Type of antiseptic fluid for D&I and DM were associated with IPP infection following surgery in our patient cohort. Disclosure No.

Abstract Introduction Since FDA approval of Collagenase Clostridium Histolyticum (CCH) for the treatment of Peyronie’s Disease (PD), there has been significant debate as to its role and comparable efficacy in relation to surgical therapies. We therefore sought to compare key outcomes between the two therapies. Objective To compare the satisfaction and adverse event profiles between surgery and CCH injections for the treatment of PD. Methods A randomized, controlled trial is ongoing. Participants were randomized 1:1 to receive either CCH + traction (RestoreX) + sildenafil (CCH) or penile surgery (plication and/or incision and grafting) + traction + sildenafil for PD (Surgery). Objective, standardized, and non-standardized assessments were obtained at baseline and 3, 6, 12, 24, 36, 48, and 60 months post-treatment. Key outcomes included differences in standardized questionnaires, penile curvature, penile length, subsequent interventions, and non-standardized questionnaire responses. Results A total of 40 men were randomized with 24-month data available in 29. Mean age was 54.7 years, PD duration 37.4 months (mo), composite curvature 73.1 degrees (deg), and penile length 12.7 cm. All baseline variables were similar between cohorts. Regarding primary outcomes, at 24-months post-treatment, CCH men were more likely to report being very satisfied with treatment (62% vs 25%, p < 0.05). For secondary outcomes, only questionnaire data were captured at two years without objective measurements obtained. No differences were noted between groups regarding subscales of the IIEF, PDQ, Beck’s Depression Inventory, or SEP-2, however CCH men had better SEP-3 positive responses (62% vs 19%, p = 0.02), indicating improved ability to maintain erections sufficient for intercourse. Surgery men reported higher subjective rates of length loss compared to CCH (81% vs 15%, p < 0.001) and curvature recurrence (56% vs 8%, p < 0.01), but similar rates with changes in sensation, indentation/hourglass, and erectile function. Both groups indicated similar willingness to undergo the therapy again. Interestingly, at 2-years, the majority of men in the Surgery arm said that their initial preference for treatment was surgery (56%), which decreased from a peak 86% at 1-year. However, in reviewing baseline information, 72% of Surgery men actually preferred CCH at study onset, highlighting a significant recall bias towards whatever treatment one actually ended up receiving. Conclusions Preliminary data suggests that when compared to surgery at 24-months, CCH men were more likely to be very satisfied with therapy, have greater subjective length improvements and lower curvature recurrence rates. Disclosure Yes, this is sponsored by industry/sponsor: Endo Pharmaceuticals. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: PathRight Medical.

Abstract Introduction Limited data currently exist on the role and efficacy of additional series of collagenase clostridium histolyticum (CCH) injections among Peyronie’s disease (PD) men who have previously failed a first series of injections. We sought to evaluate outcomes of a novel protocol for CCH injections among men who had previously failed 6-8 CCH injections using a traditional approach. Objective To evaluate whether additional rounds of CCH using a novel protocol in men previously unresponsive results in greater curve improvements. Methods A randomized, controlled trial (NCT05108558) is ongoing. All participants previously failed to achieve ≥20% curvature improvement with 6-8 prior CCH injections. Men were randomized 3:1 to receive either CCH + traction (RestoreX) + sildenafil (treatment) up front or initial observation followed by treatment (controls). Outcomes were compared between treatment and control groups. Key measures included objective curve improvements and standardized/non-standardized questionnaires, with assessments obtained at baseline, 6-weeks after completion of CCH (treatment arm), after the no treatment period (controls), and at 1 year. Results A total of 38/40 men have been randomized to date, with 22 having fully completed treatment. Mean age was 57 years, with a median PD duration of 22 months. Median composite baseline curvature was 65 degrees, with 40% having hourglass or indentation deformities, 8% calcification, median baseline IIEF-EFD 20, and 58% able to have penetrative intercourse. Median estimated improvement with the prior CCH series was 0% (IQR 0, 18.8), and the median number of prior injections was 8. The majority of men were dissatisfied with their prior series of CCH (58% vs 35% satisfied, 8% neutral). Of the 22 men who had completed the study protocol, 50% required 1 series, 14% 2 series, 29% 3 series, and 7% 4 series. Compared to the no treatment arm, treated men experienced significantly greater improvements (median 60 degrees vs 0, p = 0.01). IIEF-EFD was non-statistically higher in treated men (0 vs -5, p = 0.17). 92% of men reported a subjective major improvement in curvature, with the median subjectively estimated improvement 90%. 42% reported improved sensitivity (58% no change), while 63% reported improved or no change in erectile function, with 9% unsure, and 27% worse. Post-treatment, 92% of men were very satisfied with CCH as a treatment and 8% neutral. Conclusions Repeating CCH using a novel protocol after an initially unsuccessful course of CCH achieves significant improvements in curvature and patient satisfaction. Additional data, including external validation, are warranted. Disclosure Yes, this is sponsored by industry/sponsor: Endo Pharmaceuticals. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: PathRight Medical.

Abstract Introduction Treatment of patients with obstructive lower urinary tract symptoms has various side effects on their quality of sexual life. Objective This study aimed to compare the effects of Rezum and Rezurp (a combination of Rezum for lateral lobes and TURP for the median lobe) on erections, retrograde ejaculation, and subjective orgasm experience in patients with a significant median lobe. Methods This is a retrospective cohort study that includes patients who underwent Rezum and Rezurp between January 2021 and January 2024. Sexual outcomes were assessed at 3 months and a median follow up phone call was 33 months. Patients were queried: Any changes in erections (yes/no) and changes in ejaculation (yes/no). If yes to changes, patients were asked to further define and characterize their responses including specific effect on orgasm. The effect of surgery on sexual outcomes was explored by chi-square analysis with P ≤ 0.05 considered statistically significant. Results Sexual outcomes were obtained for 78/89 patients in the Rezurp and 97/107 patients in the Rezum group. There was no significant difference in baseline characteristics, including age, prostate volume, and medication regimens, between the two groups, as shown in Table 1. The results indicated that 78% (61/78) and 83% (86/97) of Rezurp and Rezum patients experienced no change in ejaculation. Total ejaculation loss was seen only in two Rezurp patients. Ejaculatory changes between the two groups were not significantly different, with 13.8% and 4.23% worsening for Rezurp and Rezum, respectively (P = 0.08). Changes in erections and orgasm satisfaction were not statistically significant between the two groups (P = 0.76 and 0.54, respectively). Subjective worsening in orgasm quality for Rezurp and Rezum was not different between groups (P = 0.54), with 6.4% and 4.1% worsening, respectively (Table 2). Conclusions Rezurp and Rezum have similar sexual function outcomes. Disclosure No.

Abstract Introduction Concerns exist when inflatable penile prosthesis (IPP) surgery is performed following transcorporal artificial urinary sphincter (TC-AUS) due to risk of damaging the AUS cuff during proximal corporal dilation and device placement. Aside from rare case reports, no data exists on outcomes and complications in patients who undergo IPP surgery with existing TC-AUS in place. Objective We aim to describe perioperative complications, infections, revision rates, and device longevity when IPP surgery is performed with existing TC-AUS in place. Methods A retrospective search was conducted to identify all patients who had undergone TC-AUS placement at a single institution from 2015-2023. Patients who had undergone IPP placement following TC-AUS at the same institution were identified. Operative technique for IPP placement was similar to standard IPP surgery with additional care taken to avoid the AUS device and preferential use of electrocautery over sharp dissection. Operatives notes and all patient encounters were reviewed, and data on demographics, operative details, perioperative complications, infections, revision rates, and device longevity were recorded. Results 727 patients underwent TC-AUS placement from 2015-2023. Of these, 13 patients underwent subsequent IPP placement (fig. 1). All patients had history of prostatectomy, and 6 (46%) patients had prior radiation. The median follow-up after IPP was 31.7 months and the time gap between AUS and IPP averaged 18.3 months (range 2.3 to 56.7 months). Average operative time for IPP was 85 minutes (range 53 to 202 minutes). Reservoirs were all placed contralateral to the AUS reservoir to minimize risk of injury to the AUS device. 8 patients had a 12 Fr catheter left post-operatively for less than 24 hours. Proximal dilation was noted to be difficult in 2 patients (15%), both of which were successfully dilated without perforation or damage to the AUS cuff. No infections or erosions occurred. 3 patients (23%) developed mechanical failure at a mean time of 28.7 months following IPP placement (36.5 months after AUS). Cuff leak was identified in 2 patients and the third has yet to undergo revision surgery to determine etiology. Conclusions IPP placement appears safe and effective in men who have previously undergone TC-AUS without increased risk of infection or device erosion. Care should be taken when dilating proximally, though proximal dilation was uneventful in most patients. Mechanical failure rates may be slightly higher compared to patients who have either device alone, and patients should be counseled accordingly. Disclosure No.

Abstract Introduction Penile prosthesis (PP) implantation is associated with high patient satisfaction in patients with medically refractory erectile dysfunction (ED). There remains a paucity in the literature regarding the temporal evolution of patient satisfaction and well-being following PP surgery. Objective We aimed to identify factors responsible for patient satisfaction after surgery. Methods We initiated a registry of patients undergoing surgery for placement of a PP. After consent, perioperative study assessments and follow-ups were conducted. After surgery, patients were directed to a survey at 6 months and 12 months. Patients who completed both items were included in the analysis. Results A total of 304 patients had a PP placement, of these 101 completed the initial surveys. Overall patient satisfaction was favorable and durable and 6- and 12-months (87% and 82% respectively, p = 0.11). Confidence with device use was reported by 92% at 6 months, without significant change at 1 year (vs. 95%, p = 0.91). At 6 months, 81% of patients reported that their PP met or exceeded expectations, 83% of patients reported that they would undergo the procedure again, and 80% would recommend to a friend/family member. [Figure 1] At 6 months, 78 patients (77%) reported a moderate to high improvement in their overall sense of well-being related to their PP. This percentage further increased to 91% at 12-months (p < 0.001). Additionally, 36% of patients reported that they had made significant improvements to their overall lifestyle since receiving the PP, and this increased to 48% by 12 months post-operatively (p = 0.082). Conclusions Penile prosthesis satisfaction is evident and durable as early as 6 months following surgery. Factors such as perceived overall well-being continued to significantly improve past 6 months, and nearly half of patients reported overall lifestyle improvement following surgery. Disclosure Yes, this is sponsored by industry/sponsor: Coloplast. Clarification: Industry funding only - investigator initiated and executed study.

Abstract Background The 3-piece inflatable penile prosthesis (IPP) is the most widely used device for erectile dysfunction refractory to medications, containing a reservoir inserted into the retropubic space (RPS) or an alternative/ectopic space (AES). Indications for removal of the reservoir include malfunction, malposition, or infection. In revision cases without infection, reservoir removal is sometimes optional. Aim We reviewed outcomes and complications related to reservoir removal from a large multi-institutional series. Methods We retrospectively reviewed databases at 6 institutions over 7 years. Patients with artificial urethral sphincter, urethral sling, or mini-jupette were excluded. Outcomes Outcomes and complications related to IPP reservoir removal were analyzed. Data were collected, but only reservoir-related complications at surgery were included. Data were compared between the RPS and AES cohorts to evaluate differences with a χ2 test, with significance at P < .05. Results Of 215 cases, there were 172 RPS and 43 AES reservoirs. The mean patient age was 65.3 years. An overall 131 procedures were due to malfunction and 49 to malposition of an IPP component; 35 were secondary to infection. Among those retained (n = 44), reasons included reuse, avoiding surrounding structure damage, and difficult dissection. Among those removed (n = 171), 15 required a counterincision. To determine the statistical difference between those removed from the RPS and an AES, the χ2 test result was P = .00059, indicating a significant difference in the need for a counterincision between the groups. Complications included bladder perforation (n = 1) in the RPS group and an avulsion of the epigastric vessels requiring abdominal exploration (n = 1) in the AES group. To determine the statistical difference between RPS and AES complications, the χ2 test result was P = .365, indicating no significant difference between the groups. Strengths and Limitations Strengths include being a multi-institutional study with high-volume skilled implanters. Limitations include being a retrospective review, with implanters exclusively performing penoscrotal incisions and not utilizing an infrapubic approach. Last, there was a lack of long-term follow-up with these patients. Conclusions Removal of an IPP reservoir remains safe, with few intraoperative complications. Surgeons should be aware of the inferior epigastric vessels during removal in an AES or be willing to perform a counterincision to avoid injury to surrounding structures. Surgeons should also obtain preoperative imaging to identify the specific location of the reservoir and adjacent anatomy. This is the first multi-institutional study reviewing outcomes related to reservoir removal during IPP revision or removal surgery.

Abstract Background Sexual Medicine Society of North America (SMSNA) fellowships offer variable experience in sexual health domains: erectile dysfunction, Peyronie’s disease, male infertility, male hypogonadism (low testosterone), reconstruction (including male incontinence), benign prostatic hyperplasia, gender affirmation surgery, sexual mental health, and female sexual dysfunction. Aim To evaluate baseline and postbootcamp understanding and trust in these domains. Methods In 2023, 28 of 31 urologists currently enrolled in SMSNA-endorsed fellowships participated in a 3.5-day training bootcamp in Minneapolis, Minnesota. Participants were asked to complete pre- and postbootcamp surveys. The bootcamp curriculum offered American Urological Association guidelines and case-based lectures, hands-on clinical training with cadavers (penile surgery) and models (collagenase training), and interaction with industry. Outcomes Changes in knowledge, independence, and trust in performing the procedures, as well as billing issues and feedback for future bootcamps. Results Prebootcamp surveys revealed vastly varied residency experience. Reported time with an expert faculty member was greatest for benign prostatic hyperplasia and least for female sexual dysfunction, gender affirmation surgery, and low testosterone. The lowest prebootcamp confidence in performing surgery independently was for penile grafting procedures and elevating the neurovascular bundle. Postbootcamp results revealed several areas of significant improvement in confidence (P ≤ .03): intralesional injections for Peyronie’s disease, manual modeling, penile plication, penile grafting procedures, and elevating the neurovascular bundle. There was a trend for improved confidence with the insertion of inflatable (P = .05) and semirigid (P = .08) penile prostheses. Nonsignificant improvement occurred in artificial urinary sphincter surgery (P = .12). Participants graded the bootcamp very highly and requested that next year’s bootcamp have more content on female sexual dysfunction, male incontinence, and low testosterone, as well as more hands-on skills sessions and case-based lecture formats. Clinical Implications Offering a bootcamp with hands-on instruction could significantly improve urologists’ knowledge and confidence. Strengths and Limitations As the main strength, this study was the first specialized bootcamp for urologists in the subject of men’s health, taking into account hands-on and cadaver laboratories, as well as highlighting industrial and pharmaceutical products. The small sample size was the major limitation. Conclusions Current SMSNA fellows present with varied levels of experience and confidence across sexual health domains. Notable confidence improvements were seen with topics that combined didactic lectures with hands-on trainings.

AbstractIntroductionPrior consensus meetings have addressed the relationship between phosphodiesterase type 5 (PDE5) inhibition and cardiac health. Given significant accumulation of new data in the past decade, a fourth consensus conference on this topic was convened in Pasadena, California, on March 10 and 11, 2023.ObjectivesOur meeting aimed to update existing knowledge, assess current guidelines, and make recommendations for future research and practice in this area.MethodsAn expert panel reviewed existing research and clinical practice guidelines.ResultsKey findings and clinical recommendations are the following: First, erectile dysfunction (ED) is a risk marker and enhancer for cardiovascular (CV) disease. For men with ED and intermediate levels of CV risk, coronary artery calcium (CAC) computed tomography should be considered in addition to previous management algorithms. Second, sexual activity is generally safe for men with ED, although stress testing should still be considered for men with reduced exercise tolerance or ischemia. Third, the safety of PDE5 inhibitor use with concomitant medications was reviewed in depth, particularly concomitant use with nitrates or alpha-blockers. With rare exceptions, PDE5 inhibitors can be safely used in men being treated for hypertension, lower urinary tract symptoms and other common male disorders. Fourth, for men unresponsive to oral therapy or with absolute contraindications for PDE5 inhibitor administration, multiple treatment options can be selected. These were reviewed in depth with clinical recommendations. Fifth, evidence from retrospective studies points strongly toward cardioprotective effects of chronic PDE5-inhibitor use in men. Decreased rates of adverse cardiac outcomes in men taking PDE-5 inhibitors has been consistently reported from multiple studies. Sixth, recommendations were made regarding over-the-counter access and potential risks of dietary supplement adulteration. Seventh, although limited data exist in women, PDE5 inhibitors are generally safe and are being tested for use in multiple new indications.ConclusionStudies support the overall cardiovascular safety of the PDE5 inhibitors. New indications and applications were reviewed in depth.