Trost, L.

Abstract Introduction Significant clinical variations exist in the definitions of acute/active vs chronic/stable Peyronie’s Disease (PD). While the American Urological Association’s 2015 guidelines define the acute phase as involving symptoms that change and the presence of pain, they do not specify a timeframe. Historically, acute-phase features include penile pain and worsening curvature, with symptom duration ranging from less than 3 to 18 months. Although temporally categorizing PD may have academic value, it may unnecessarily limit or delay treatment. In the United States, collagenase clostridium histolyticum (CCH) is the only FDA-approved treatment for adult men with PD who have a palpable plaque and a curvature deformity of at least 30 degrees. Several real-world studies suggest CCH is safe and effective during the acute phase. Objective To evaluate differences in outcomes by penile pain and symptom duration and to determine whether these factors should inform timing of CCH treatment in men with Peyronie’s disease. Methods A post hoc analysis of pooled data from 2 phase 3 randomized double-blind trials of CCH in PD (IMPRESS I, NCT01221597; IMPRESS II, NCT01221623). Men treated with CCH were stratified by baseline penile pain (Any Pain vs No Pain), based on both investigator-assessed and patient-reported measures. A subgroup analysis further stratified men with Any Pain by disease duration. The primary efficacy endpoint in the phase 3 study was the percentage change in penile curvature from baseline to week 52. A 2-sample t test was used to compare group means for each pain-related measure. Results A total of 364 CCH-treated men were included. Mean penile curvature improvements at week 52 were similar across all 4 investigator-assessed and patient-reported penile pain measures (35.0%-36.7% improvement for the No Pain group vs 32.2%-33.9% improvement for the Any Pain group, P=0.14-0.65). Among those experiencing Any Pain, no statistical differences were observed in men with disease durations that were shorter (12-18 months; 21.8%-34.8% improvement) vs longer (greater than 18 months; 31.4%-36.8% improvement, P=0.20-0.95). Conclusions This study found similar curvature improvements among men treated with CCH regardless of baseline pain or disease duration. Results align with prior studies showing no outcome differences by pain status or disease phase. These findings suggest that pain and disease duration should not be viewed as contraindications to CCH or used to guide clinical decision-making. Disclosure Yes, this is sponsored by industry/sponsor: Endo USA, Inc. Clarification: Industry initiated, executed and funded study Any of the authors act as a consultant, employee or shareholder of an industry for: Endo USA, Inc.

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 exist on semen parameters post vasectomy reversal. Specifically, no studies have rigorously evaluated the likelihood of sperm return following discovery of azoospermia at some time point post vasectomy reversal. Objective To evaluate the rate of return of sperm among men who experience an azoospermia result post vasectomy-reversal. Methods A large, prospective dataset has been maintained of men undergoing vasectomy reversals at a single center from 2019 to the present. Men who had at least two post-operative semen analyses were included for review. The data were then analyzed in a manner to identify those who experienced a 0 count at varying time points and then either went on to continue to have 0’s beyond that point or who experienced a return of sperm. Results A total of 3414 men underwent a vasectomy reversal since 2019, with 2703 having semen analysis data available for review. Overall demographics demonstrated a mean age of 41, partner age 33, median time since vasectomy of 7 years, 92% first-time cases, and distribution of repair as noted: VV/VV (79%), VV/EV (12%), EV/EV (6%), VV/x (1%), EV/x (<1%), x/x (0%). Of men who had 0 sperm at varying time points, the percentages of those who experienced a return of sperm are noted as follows: 0 sperm at <2 months (52% experienced a return at some point, n = 349 used in calculation), 0 at 2-4 months (38% return, n = 210), 0 at 5-7 months (17% return, n = 206), 0 at 8-10 months (20% return, n = 133), 0 at 11-18 months (9% return, n = 107). The data are limited by the fact that relatively few men continued to send in semen analysis samples beyond 12 months (n = 403 with at least one result >12 months and n = 101 with results >24 months). Conclusions Men who experience azoospermia post-vasectomy reversal may experience a return of sperm over time, with the likelihood for return declining based on the duration of persistence of 0 sperm. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: PathRight Medical.