Broderick, G

Abstract Introduction The EROS (Erectile Restoration Outcomes and Satisfaction) registry provides prospective, questionnaire-based follow-up after IPP, established in 2020. Objective We sought to assess general trends in the open-ended responses portion of the questionnaire. Methods Data were collected from 2020 to 2025, with a total of 568 responses. The survey included six open-ended questions pertaining to lifestyle change since IPP, reasons not to repeat the procedure, impediments to use, dissatisfaction, what patients wish they had known more about the procedure, and other recommendations. Evaluable data included 6-month responses from Rochester, Jacksonville, and Phoenix. Results Open-ended feedback was given by 66% of patients on what they wished they had known, 54% gave other recommendations, 38% gave lifestyle feedback, 7% elaborated upon reasons not to use, 3% on reasons for dissatisfaction, and 2% on reasons they would not repeat IPP. There was an overall very positive response (“Significant Improvement”, n=74.3%) from those who underwent the IPP placement, with some patients reporting that it was far more convenient than other forms of treatment, and even increased spontaneity in their sexual lives, leading to improved relationships. Among the reported responses are increased confidence (n=39.4%), increased sexual activity (n=13.3%), and improved health and exercise levels (n=6.6%). When questioning patients about why they would not repeat the procedure and what their sources of dissatisfaction were, among those who responded to each question (n=12, n=16), the most frequently reported complaint was the exaggeration of pre-existing curves (n=41.7%, n=25.0%), particularly due to Peyronie’s disease. When questioned about what prevents use, the main responses were partner-related or due to personal problems (n=45.2%). The patients did not have many recommendations, but hoped for a better way to deflate and inflate the device (n=20.4%) and reported adequate pre-operative education and use of the pump. The table below outlines the categories of responses and the percentage of each keyword reported per question type. Conclusions In addition to standard pre-operative IPP counseling, providers should also focus on potential difficulties with device inflation/deflation, length loss (IPP not in the glans), pain/ recovery expectations, the potential for new or worsened curve (erect or flaccid), and potential changes in sensation. IPP satisfaction is high, as only 2% of patients gave responses on why they would not repeat the IPP, with many men expressing an increased level of overall confidence. Disclosure No

Abstract Introduction Penile plication is the gold standard operation for Peyronie’s disease with preserved erectile function but is associated with persistence of hourglass shaft deformity and palpable, permanent plication sutures that may be bothersome in some patients. A novel technique utilizing extratunical grafting overlying plication sutures in the tunica albuginea may improve patient discomfort, increase penile girth, and improve overall satisfaction. Objective We aim to analyze patient centered outcomes and satisfaction scores associated with this operation. Methods We retrospectively evaluated 13 patients who underwent Peyronie’s correction with penile plication with extratunical onlay grafting with biological Dura substitute graft performed by a single surgeon at a tertiary academic center. The graft was placed over 2-0 Ethibond Lue plication sutures in a circumferential fashion sparing the neurovascular bundle and secured with chromic suture. Primary endpoints of interest were patient satisfaction scores (1-10), presence of hourglass, palpability of sutures as well as associated discomfort, and sexual activity. Results Median follow up was 15.4 months. 100% of patient were sexually active at time of follow up. Mean patient reported post operative satisfaction was 8.9 out of 10. No patients endorsed palpability of plication sutures, coital discomfort at site of repair, or persistence of hourglass or concavity deformity. In patients who reported less than a 10 in satisfaction, areas of dissatisfaction include persistence of curvature, albeit decreased pre-operatively, as well as enhanced girth associated with dyspareunia of the receptive partner during intercourse in a single patient. Conclusions We present excellent post operative satisfaction and patient centered outcomes utilizing extratunical grafting overlying penile plication sutures in Peyronie’s disease repair. This novel technique may meaningfully improve patient satisfaction is patients with Peyronie’s disease undergoing plication alone. Disclosure No

Abstract Introduction Peyronie’s disease (PD) and ED can coexist, affecting the patient’s perception of erectile function. The AUA guidelines recommend intracavernosal injection, with or without doppler ultrasound, prior to invasive interventions. Our objective was to assess vascular erectile integrity in patients with PD. Objective The objective of our study was to assess vascular erectile integrity in patients with PD. Methods We retrospectively reviewed 2309 patients who underwent color doppler duplex ultrasound (CDDU) at our institution. CDDU findings such as peak systolic velocities and resistive indices were recorded following injection of low dose Alprostadil and again after a period of privacy and visual sexual stimulation. Among patients diagnosed with PD, comparisons of patient characteristics between those with PD only and those with PD and ED were made using ANOVA (continuous characteristics) or Chi-squared test (categorical characteristics). Results Of men that underwent CDDU, 1468/2452 (63%) were diagnosed with PD. Among those with PD, 327 (14%) were diagnosed with PD only and 1141 (49.4%) were diagnosed with both PD and ED. Those with PD only had lower BMI (27.1 vs 28.4), were less likely to have hypertension (37% vs 46%), less likely to have Diabetes Type 2 (16% vs 31%), less likely to have used PDE-5 inhibitor (39% vs 82%), and less likely to have failed to a PDE-5 inhibitor (30% vs 73%) compared to men with both PD and ED, all p<0.005. Average SHIM scores were higher among those with PD only compared to PD and ED (18 vs 12). CDDU diagnoses for men with PD and ED were: AI (32%), CVOD (43%), mixed vascular ED (26%). Conclusions In a large cohort of men with PD we identified multiple potential risk factors for erectile dysfunction. CDDU of men with PD demonstrates that three-quarters of patients have some form of vascular erectile dysfunction. Counselling for surgical interventions should include a Doppler assessment to ensure patients are appropriately triaged to PD-corrective surgery versus penile implant. Future AUA Guidelines should reclassify the recommendation for evidence-based testing prior to surgical interventions from ‘Expert Opinion’ to ‘Clinical Principle’. Disclosure No

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 Peyronie’s disease (PD) is traditionally categorized into 2 phases: acute (active) and chronic (stable) phase; however, clinical definitions and distinction between the phases vary in the literature and remain blurred.[1] The American Urological Association guidelines outline changing symptoms with the presence of pain as a defining symptom of acute disease, but provide little guidance about timeframe.[2] Historically, acute-phase characteristics include presence of penile pain and progressing deformity (eg, worsening penile curvature), with time from symptom onset to acute phase completion being <3–18 months.[1] While there may be academic utility in temporally categorizing PD, it may limit or postpone the treatment options for patients suffering from the condition. Collagenase clostridium histolyticum (CCH) is an approved nonsurgical PD treatment option and several studies suggest its safety and efficacy in acute phase PD.[3-6] In light of these studies and ambiguity in dichotomizing phases, previous clinical trial data were reanalyzed to investigate the potential for opening the gamut of treatment options at earlier timepoints in the disease process. Objective This analysis examines CCH treatment efficacy on improving penile curvature in participants presenting with/without penile pain at baseline and disease duration of 12–18 months or >18 months from the CCH clinical trial program. Methods Literature related to CCH treatment of acute phase PD was compiled and treatment outcomes assessed. Additionally, a post hoc analysis of pooled data from two phase 3 randomized, double-blind trials of CCH in PD (IMPRESS I, NCT01221597; IMPRESS II, NCT01221623) was conducted. CCH-treated participants were stratified by the reporting of moderate-severe pain or no pain at baseline based on the following study measures: penile pain on palpation, penile pain on erection, PD questionnaire (PDQ) combined questions 7–9, and PDQ question 10 only. Additional subgroup analyses stratified participants by presence of pain and disease duration (12–18 or >18 months). The primary efficacy endpoint was the percentage change in penile curvature at week 52 from baseline. Results The IMPRESS I/II data analysis found that participants who experienced moderate-severe pain at baseline had penile curvature improvements by week 52 similar to participants with no pain at baseline. Across all pain measures, the percentage decreases in mean penile curvature from baseline ranged from 29%–42% for moderate-severe pain groups and 35%–37% for no penile pain groups. There were no clear differences in mean penile curvature improvement between groups for any specific pain measure when stratified by disease duration of 12–18 months (moderate-severe pain, 32%–40% improvement; no pain, 23%–29% improvement) versus >18 months (moderate-severe pain, 24%–44% improvement; no pain, 37%–40% improvement). Outcomes from the IMPRESS trials were comparable in context with published literature. Conclusions Based on a subanalysis of IMPRESS data, there were no clear differences identified in CCH treatment outcomes between participants experiencing moderate-severe pain or no pain at baseline regardless of disease duration (12–18 versus >18 months). These analyses are consistent with other literature evaluating the efficacy of CCH in the acute phase of disease and suggest that ongoing pain is not a contraindication to CCH therapy. Disclosure Yes, this is sponsored by industry/sponsor: Endo Pharmaceuticals Inc. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Endo Pharmaceuticals Inc; Boston Scientific Corporation; Antares Pharma, Inc; PathRight Medical.

ABSTRACT Introduction The prevalence of erectile complaints in the US is estimated to be more than 50%. Most of the time ED complaints are evaluated and treated in the primary care setting. However, when first line measures are not efficient, patients are referred to general Urologists or to a specialized center. Objective The primary aim of this study is to describe the characteristics of patients referred to a tertiary center for evaluation of erectile complaints not responding to traditional first line therapies and, or patients with an associated complaint of penile deformity (rule out Peyronie's Disease/PD). Methods We retrospectively analyzed a cohort of patients between 2005 and 2019, detailing primary complaints, sexual histories, self-assessment scores, medical history and results of in office intracavernous injection followed by Color Doppler Duplex Ultrasound (CDDU). CDDU findings were recorded following injection of low dose alprostadil (10-20 mcg) and again after a period of privacy and visual sexual stimulation. CDDU findings including peak systolic velocities (PSV), and resistive indices (RIs) were recorded. Arterial insufficiency (AI) was defined as either a post-stimulation PSV < 25 (severe) or a PSV 25-34.9 with RI ≥ 0.9 (moderate). Cavernous venous occlusion disease (CVOD) was defined as post-stimulation PSV ≥35 with RI < 0.9. Vascular normal was defined as post-stim PSV ≥ 35 with RI ≥ 0.9. Results A total of 1490 patients with a median age of 60 (range, 18 – 88), median BMI of 28.4 (range, 15.9 – 56.8) and median Sexual Health Inventory for Men (SHIM) score of 10 (range, 0-25). In our cohort, 257/1489 (17.3%) patients had heart disease, 656/1489 (44.1%) patients had hypertension, 520/1489 (34.9%) patients had diabetes, and 203/1488 (13.6%) patients had a past medical history of hypertriglyceridemia. Smoking history was present in 853/1478 (57.7%) of patients and complaint of PDE-5 failure was made by 945/1201 (78.7%) patients who reported using it. 900 patients (60.4%) had a complaint of penile deformities and ED, 461 (30.9%) had a complaint of ED only, and 129 (8.7%) had a complaint of PD only. Prostate surgery history was noted in 316 men: radical retropubic prostatectomy 108, robotic assisted prostatectomy 134 and endoscopic resection or enucleation 74. Following CDDU we confirmed 767 (51.5%) patients with both ED and PD, 351 (23.6%) with ED only, and 310 (20.8%) PD only. We found 62 men (4.2%) had normal vascular erectile response to low dosage PGE1 (diagnosed as psychogenic ED vs. post-prostatectomy neurogenic ED). Among the 351 patients with ED only on Doppler, 132 (37.6%) had AI, 124 (35.3%) had CVOD, and 95 (27.1%) had a mixed vascular diagnosis. Among patients with vascular ED on diagnoses by CDDU, 73/351 (20.8%) had heart disease, 192/349 (55.0%) had smoking history, 273/311 (87.8%) complained of PDE5-inhibitor failure, 130/351 (37.0%) had diabetes, and median SHIM score was 7 (range 1-25). Conclusions This summary describes the characteristics in 1490 men who presented for evaluation of erectile complaints and or complaints of penile deformity to a tertiary care center. Patients referred to Urologists have complex ED, defined as refractory to PDE5-Inhibitors, associated with penile deformities, and multiple medical / surgical risk factors. Disclosure No

ABSTRACT Introduction Peyronie's Disease (PD) can coexist with erectile dysfunction (ED). International guidelines recommend that management of PD include an assessment of each patient's ability to initiate and sustain erection. PD causes significant stress to the patient and his partner; that distress may limit their ability to assess adequacy of penile rigidity. Further complicating evaluations based on history is the fact that PDE5-Inhibitor use is common. Objective The primary aim of this study is to non-invasively assess vascular erectile integrity in the setting of PD. Methods 1490 patients who underwent intracavernous injection (ICI) followed by Color Doppler Duplex Ultrasound (CDDU) at our institution were retrospectively analyzed. CDDU findings were recorded following injection of low dose alprostadil (10-20 mcg) and again after a period of privacy and visual sexual stimulation. CCDU findings including peak systolic velocities (PSV), and resistive indices (RIs) were recorded. Arterial insufficiency (AI) was defined as either a post-stimulation PSV < 25 cm/sec (severe AI) or a PSV 25-34.9, RI ≥ 0.9(mild AI). Cavernous Venous Occlusion Disease (CVOD) was defined as post-stimulation PSV ≥ 35 cm/sec with RI < 0.9. Mixed was defined as post-stimulation PSV 25-34.9 with RI < 0.9. Vascular normal was defined as post-stim PSV ≥ 35 with RI ≥ 0.9. Results Our cohort of 1490 patients included 900 (60.4%) with a complaint of both PD + ED; 461 (30.9%) with complaint of ED only and 129 (8.7%) with complaint of PD only. Following ICI with PGE1, 310 men were found to have PD and 767 were found to have PD + ED. Patients with a CDDU confirmed diagnosis of PD alone were younger (median: 56.9 vs. 60.8 y, p < 0.001), less likely to have hypertension [103/310 (33.2%) vs. 365/767 (47.6%), p < 0.001], less likely to have used PDE-5 inhibitor [219/310 (70.6%) vs. 616/767 (80.3%), p < 0.001], and less likely to have failed to a PDE-5 inhibitor [142/219 (64.8%) vs. 484/616 (78.6%, p < 0.001]. Diabetes was slightly more common in men with PD + ED compared to PD [270 (35.2%) vs. 94 (30.3%), p = 0.063], but not statistically significant. CDDU diagnoses for men with ED + PD were: AI 262/767 (34.2%), CVOD 305/767 (39.8%), mixed vascular ED 200/767 (26.1%). By definition all men with PD alone were vascular normal. Self-assessments by SHIM scores were abnormal in both groups ED + PD and PD [median(interquartile range): 10 (5 – 17) vs. 14 (8 – 20), p< 0.001]. Conclusions By history alone, patients with ED + PD vs. PD only can't reliably be identified. This is likely related to the distress caused by PD and the tendency to physicians to treat or patients to self-medicate all erectile complaints with PDE5-Inhibitors. For non-invasive treatments distinguishing between ED + PD vs. PD is not critical. Before any patient is triaged to surgical intervention an evidence-based assessment of vascular erectile integrity should be performed. In our cohort of men, Doppler analysis demonstrated that at least 6 out of 10 PD patients have some form of vascular ED. Disclosure No