Ziegelmann, M

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 Penile plication is an excellent approach for patients with congenital penile curvature and Peyronie’s disease. Beginning in March of 2023, patients who were candidates for penile plication were offered the procedure in the operating room under general anesthesia or in the office setting with no sedation. Fourteen patients opted for the procedure in the clinic. Objective We therefore sought to assess patient responses and experience after undergoing surgery in the clinic setting. Methods Fifteen patients, ages ranging from 21 to 74 were seen in clinic for penile plication surgery. Exclusion criteria included patients younger than 18 years and preoperative systolic blood pressure greater than 160. One patient was noted to have a systolic blood pressure over 200 and thus was unable to have the procedure. Five patients had a penile plication for congenital curvature, eight patients for Peyronie’s disease, and 1 patient had a release of a previously placed palpable plication suture. Degree of curvature, direction of curvature, presence of secondary curvature, presence of hinge defect, and indentation were not considerations in patient selection. Three patients were on anticoagulation, which was held prior to surgery. Twelve patients underwent a ventral approach and two a degloving approach. Results Patients are allowed and encouraged to eat and drink prior to the procedure. All patients were given a preoperative antibiotic, normally either Bactrim or ciprofloxacin prior to the procedure and 20 mg of oral versed. They were then taken to the in-office procedure room after consent was obtained. The procedure room contains a television for patients to watch. At the end of the procedure, an Exparel block was performed. Patients are then prepped and draped in standard sterile fashion. A dorsal penile nerve block and circumferential block were utilized at the beginning of the case. A catheter is not placed to help reduce patient discomfort. Alprostadil is injected to help identify curvature. Ten patients were noted to have dorsal, 2 patients’ ventral, and 2 patients’ lateral curvature with degree of curvature ranging from 30 to 60 degrees. Eight patients had a secondary curvature identified. Total number of plication sutures utilized ranged from 2 to 8. All procedures were successfully conducted, and patients discharged home. Patients were then contacted to determine their experiences with the procedure. Only seven patients were able to be reached. One patient did have a vasovagal response in the procedure room, but this resolved with a small snack. Average intraoperative discomfort was rated as a 2/10 and was mainly present during the initial block. All patients stated that they would choose this surgical approach again and have noted clinically significant improvement to their curvature. Conclusions Penile plication in the clinic setting reduces anesthetic risks as well as costs associated with the operating room. This study shows the safety and feasibility of this approach. Disclosure No.

Abstract Introduction Peyronie’s disease is characterized by penile plaque or scar within the tunica albuginea. This results in penile deformity, most commonly penile curvature but also volume loss deformity such as hourglass or indentation. This volume loss occurs in up to 65% of men with Peyroine’s disease. Surgical management for patients with significant deformity includes plaque incision/partial excision and penile grafting with an absorbable grafting material. In the original description of extra-tunical grafting, the grafting material was placed over Buck’s fascia via a ventral longitudinal incision. In our modified technique, the grafting material is placed under Buck’s fascia and superficial to the tunica albuginea, which allows the grafting material to be less palpable in the flaccid condition. Objective To demonstrate a modified approach to Extra-Tunical Grafting for peyronie’s disease indentation deformity. Methods Intra-operative video of modified extra-tunical grafting was recorded with an overhead surgical camera. Results Successful modified extra-tunical grafting with excellent penile straightening and restoration of penile girth and minimal palpability of the graft. Conclusions Our modified extra-tunical grafting technique is a reasonable option compared to the standard grafting technique Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast.

Abstract Introduction Erectile dysfunction (ED) stems from a variety of etiologies and often requires a multidisciplinary approach to optimize patient care. Objective We sought to assess attitudes and confidence regarding the treatment of erectile dysfunction across different provider types. Methods Responses were obtained through an anonymous, email-based survey of our institution's providers in the disciplines of urology, internal medicine, and family medicine. We created a novel tool of 25 5-point Likert scale questions regarding ED treatment. Data were analyzed through descriptive statistics and Fisher’s exact test and sorted by respondent specialty. Ethical Committee approval was obtained before study. Results 138 health care providers returned surveys, including 58 internists (IM), 47 family physicians (FP), and 33 urologists (GU). FP and IM responses showed significant overlap with a few key statistically significant differences. In general, IM was much more positive in VED, penile implant as an option, penile implant satisfaction, and penile implant risk. 37% of IM agreed or strongly agreed inflatable penile prosthesis risk is low vs 6% FP (p = .0032). IM also more strongly supported team-based care and referral to specialists IM 71% vs. 51% FP (p = .0012). (Figures) When comparing GU versus FP + IM 24/25 questions revealed statistically significant differences revealing greater GU confidence and knowledge about ED with only the importance of a team-based approach not differing. Noteworthy points include 46% vs. 18% confidence for a detailed sexual history for GU vs. FP + IM (all other points % and same provider sequence). IIEF usage and familiarity were 61 vs. 3 and 88 vs. 18, respectively. 100 and 85 strongly/agreed that good options remained after pills failed. Regarding inflatable penile prosthesis, agreement or strong agreement for patient willingness to undergo surgery for ED 67 vs. 13; patient satisfaction 91 vs. 25, partner satisfaction 80 vs. 25; and would repeat surgery or recommend to a friend was 82 vs. 17. Finally, and perhaps most notably 83 vs. 11 of providers were aware that Medicare covered implants. (Figures). Conclusions Conclusions This survey reveals significant knowledge gaps for treatment options and outcomes for ED. Targeted provider education, particularly about penile prostheses, could optimize patient care. Disclosure No

Abstract Introduction Collagenase Clostridium Histolyticum (CCH) is an FDA-approved treatment for Peyronie’s Disease (PD). Based on phase-3 trials, the recommended treatment course consists of 8-injections over the course of roughly 18-20 weeks. While its efficacy has been established, less is known about patient-specific reasons for electing to discontinue CCH injection therapy. Objective To evaluate patient-reported factors associated with premature CCH discontinuation. Methods We queried a database of all patients (n=406) who underwent CCH at a single institution from 2014-2021. Patients who did not complete the recommended 8 injections were identified, and a detailed review was undertaken to determine causes of discontinuation. Patients were excluded from our analysis for the following reasons: deceased at the time of chart review, declined to participate, or could not be reached in 3 phone calls. Results Out of 406 patients who underwent Xiaflex treatment at our single institution, 133 did not complete 8 injections (32.8%). The mean number of CCH injections was 4.42 (SD 1.65). The most common reasons for discontinuing Xiaflex were satisfactory curve reduction (27%), unsatisfactory curve reduction (21%), bothersome side effect (15%), and decision to pursue surgery (12%) [Figure 1]. Other less common reasons included other health concerns, pausing treatments due to the Covid-19 pandemic, high treatment cost, transferring care elsewhere, and lack of awareness that more injections were indicated. Conclusions In our single institution study, we find that nearly 1/3 of patients who begin Xiaflex injections will not complete the full recommended treatment course. Understanding the reasons for discontinuation can help providers better stratify patients for Xiaflex treatment versus other modalities. In addition, given previous studies that indicate that 2/3 of men who fail to achieve a 20% curve reduction after their first 4 injections will go on to achieve this curve reduction after their final 4 injections, our data points to the potential impact of improved patient education for the 21% of individuals who discontinue due to unsatisfactory curve reduction (Alom et al 2021). Disclosure No

ABSTRACT Introduction Vasectomy reversal (VR) is rarely covered by insurance, creating a market similar to cosmetic surgery with direct marketing to patients. While cost is an immediate concern for patients, surgeon training and experience are essential for a successful outcome. Patients considering VR are likely to seek information online regarding providers and the nature of the procedure. Objective In this study, we reviewed the characteristics of providers marketing VR online, as well as the comprehensiveness of their website content. Additionally, we sought to determine differences in VR practice patterns between academic and private practices. Methods We identified VR practices operating within the top 50 populous metropolitan areas in the USA. Practice websites were reviewed to obtain information such as educational background of providers, use of operating microscope, ability to perform vasoepididymostomy (VE), surgical volume, and out-of-pocket cost. Based on the information available from practice websites, providers were assigned a non-validated “REVERSAL score” out of 12, based on 8 domains (Risks disclosure; provider's Educational background; ability to perform VE; Expense disclosure; success Rate disclosure; Surgical volume disclosure; disclosure of Alternatives to VR; and Level of magnification used for VR) (Table). Descriptive statistics were used to compare the results between academic and private practices. Results 107 providers were identified (29 academic and 78 private). All but 2 were male, and similarly all but 2 had Doctor of Medicine (M.D.) degree. Review of practice websites allowed us to obtain complete information (REVERSAL score of 12) on only one provider (academic), with the majority (66%) of providers achieving REVERSAL score of ≤6. Providers with formal fellowship training in andrology, microsurgery, and/or infertility achieved higher REVERSAL scores compared to those without (6.9 ± 2.4 vs. 4.8 ± 2.4, p < 0.01). Academic providers were more likely to have completed pertinent fellowship training compared to private practice providers (97% vs. 44%, p < 0.05). Only 14% of academic providers disclosed procedure cost online, compared to 40% of private practice providers (p < 0.05). There was a trend toward increased use of online advertisements by private practice providers (22% vs. 10%, p = 0.07), and increased reference to literature success rates by academic providers (59% vs. 41%, p = 0.10). Among the 35 providers who disclosed pricing online, mean cost of VR was $5,990 ± 1,935. There was a non-significant trend toward increased cost with academic practices compared to private practices ($7,337 ± 1,103 vs. $5,765 ± 1,964, p = 0.09). There was significant reduction in cost when comparing non-urologists vs. urologists ($3,584 ± 1,554 vs. $6,591 ± 1,518, p < 0.01), and when comparing providers without pertinent fellowship training to those with ($5,405 ± 2,000 vs. $6,769 ± 1,590, p < 0.05). Conclusions There is significant lack of transparency in publicly available information from VR practices, both academic and private. Practices should implement measures to improve the dissemination of information to the general public, so that patients may more easily compare various providers. Disclosure Work supported by industry: no. A consultant, employee (part time or full time) or shareholder is among the authors (Coloplast, AMS).

ABSTRACT Background Penile length loss and erectile dysfunction (ED) are common post-prostatectomy. Recent results from a randomized, controlled study (RCT) of RestoreX penile traction therapy (RxPTT) demonstrated preserved erectile function and penile length improvements in men post-prostatectomy. Objective To report outcomes of the open label phase (6-9 month time point) of the previously noted RCT comparing efficacy of RxPTT to control in men post-prostatectomy. Methods A randomized, controlled trial (NCT03500419) has been completed of 82 men post-prostatectomy. Men were randomized 1-month post-prostatectomy to no therapy (control, n=27) or RxPTT (n=55) for 5 months. Participants then entered an open label phase for 3 months. Assessments included stretched penile length (corona), standardized (International Index of Erectile Function [IIEF]), and non-standardized questionnaires. Comparisons were performed of men who utilized traction at least 15 minutes daily for both phases to men who were originally control and continued with no treatment (as-treated analysis). Analyses were also performed of men who crossed over from control to >15 min daily (crossover to treatment) and those who were originally in the treatment group and continued with >15 min daily use during the open label phase (ongoing treatment). Results Of the 82 men enrolled (mean age 58.6), 55 had 6-month, and 42 had 9-month data available to review. Baseline characteristics (IIEF scores, penile length) were similar between cohorts. In the as-treated analysis (no treatment n=7, RxPTT x 8 months n=12, respectively), differences were as noted: IIEF-EFD (-8 vs -0.5, p=0.19), IIEF-OFD (-3 vs -2, p=0.86), IIEF-SD (-1 vs 0.5, p=0.09), IIEF-ISD (-3 vs -0.5, p=0.31), IIEF-OSD (-2 vs 0, p=0.29), penile length (-0.1 vs +1.8 cm, p<0.01), PDE5 use (86% vs 75%, p=0.57), intracavernosal injection use (86% vs 17%, p<0.01). Comparing men who did not use therapy at any time (n=7) to those who crossed over to RxPTT during the open label phase (n=8) demonstrated the following results: IIEF-EFD (-8 vs -6, p=0.49), IIEF-OFD (-3 vs -1, p=0.90), IIEF-SD (-1 vs 0, p=0.55), IIEF-ISD (-3 vs -1, p=0.45), IIEF-OSD (-2 vs -1, p=0.51), penile length (-0.1 vs +0.69 cm, p=0.39). Men who crossed over from RxPTT to no treatment (n=10) had relatively preserved improvements compared to those who continued with RxPTT during the open label phase (n=12) compared to baseline, respectively: IIEF-EFD (0 vs -0.5, p=0.95), IIEF-OFD (-3.5 vs -2, p=0.97), IIEF-SD (0 vs 0.5, p=0.18), IIEF-ISD (0 vs -0.5, p=0.87), IIEF-OSD (0 vs 0, p=0.66), penile length (+1.8 vs +1.8, p=0.99). Conclusions Although sample size and statistical power are limited, results from the open label phase confirm earlier findings of preserved sexual function and penile length in men treated with RxPTT compared to controls. Men who crossed over from controls to treatment experience benefits, although not as significant as those who were treated beginning at 1 month post-prostatectomy. Men who stopped therapy after 6 months demonstrated stable improvements from baseline, suggesting a preserved effect of RxPTT even after discontinuing use. If validated with external series, these findings would represent a significant advancement in the prevention of sexual dysfunction post-prostatectomy. Disclosure Work supported by industry: no.

ABSTRACT Introduction The significant overlap of risk factors for erectile dysfunction and venous thromboembolism (VTE) may disproportionally increase the risk of VTE in men undergoing inflatable penile prosthesis (IPP) surgery. Owing to the absence of available literature, AUA and EAU perioperative VTE guidelines do not address VTE risk with IPP surgery and generally recommend against pharmacologic prophylaxis with outpatient surgery. The Caprini Score is a validated scoring system to estimate VTE risk in the perioperative period. Objective We sought to assess the risk of VTE by calculating Caprini Scores in men undergoing IPP surgery. Methods We retrospectively reviewed and calculated Caprini Scores for patients undergoing IPP surgery at our institution between July 2017 and June 2019. Results 215 patients undergoing IPP surgery were identified with a mean and median Caprini score of 5.96 (SD, 1.63) and 6 (IQR 5,7), respectively. 84% of the cohort was classified as high or highest risk for VTE (Figure 1). This is in part due to our cohort's mean age of 64, mean BMI of 31 and history of prostate cancer treatment as the cause of ED. Prior history of VTE (deep vein thrombosis(DVT) or pulmonary embolism (PE)was identified in 17 (8%) patients with 5 (2%) have a history of both DVT and PE. Conclusions Men undergoing IPP surgery are high risk for VTE based on Caprini score assessment. VTE prophylaxis should be considered in men undergoing penile implant surgery. Before widespread application, long-term data is necessary to assess safety and efficacy of VTE prophylaxis in the IPP surgery population. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Senior author consultant for Coloplast

ABSTRACT Introduction Chronic pelvic and/or genital pain is a disabling condition and commonly associated with poor quality of life, impaired sexual function and decreased productivity. Objective To examine treatment outcomes among a cohort of patients diagnosed with refractory pelvic and/or genital pain enrolled in a 3-week interdisciplinary pain rehabilitation program (IPRP). Methods A series of with-in subjects ANOVAs (corrected for multiple comparisons) were used to evaluate the effectiveness of IPRP on self-report (pain severity, interference, depressive symptoms, quality of life) and observer-rated outcome (5 minute walk) among 15 treated patients receiving care at the Mayo Clinic IPRP between 2016-2018. Results Fifteen patients (5 male, 10 female) were identified. Mean age was 47.0 (range: 24-78) and primary diagnoses were pelvic pain (n=13) and penile pain (n=2). Significant within-subject effects were detected for all self-report outcomes and the 5-minute walk test (see table 1). Six patients were on opioid therapy (MME = 49mg), and all but one successfully tapered off opioids. In the remaining patient, daily MME decreased from 150 mg to 30 mg. Conclusions Intensive outpatient IPRP significantly improves quality of life for patients with treatment-refractory chronic pelvic and/or genital pain. These results support multi-disciplinary treatment paradigms for refractory urogenital pain. Disclosure No

ABSTRACT Introduction Despite an increasing number of publications on Peyronie's disease (PD), evidence-based clinical decision making remains challenging due to the small number of well-designed clinical trials. The quality of available PD literature has not been assessed to date. Objective We sought to evaluate the quality of the methodology and reporting of systematic reviews and meta-analyses in PD literature Methods Study protocol registration was performed on the Open Science Framework platform. In January 2021, a systematic electronic search of the Medline/PubMed, Embase, Ovid, Scopus, Joanne Briggs Institute and Cochrane databases was performed. Search terms included “Peyronie's disease” and “systematic review OR meta-analysis OR meta analysis”. Eligibility criteria were relevance to Peyronie's disease and specification of “systematic review” or “meta-analysis” in the title or abstract. A database was created to summarize the relevant methodological and reporting criteria for each article. The outcomes included review type, authorship, journal, publication date, “A MeaSurement Tool to Assess systematic Reviews” (AMSTAR-2) score and “Preferred Reporting Items for Systematic Reviews and Meta-Analyses” (PRISMA) score. Risk of bias was assessed using the ROBIS tool. Data were tabulated and reported as means with standard deviation, median with interquartile range (IQR) and t-testing as appropriate. Strength of association between variables was calculated using the Pearson correlation coefficient. Statistical analyses were performed on RStudio (version 1.4.1106). Results From 1974 to 2021, 340 articles were identified. After review 23 full length articles were included. Seventeen were systematic reviews, 4 meta-analyses and 2 were combined. Twenty-one (87.5%) articles were published after the year 2009 when the PRISMA guidelines were published. There was median 53.8% (IQR 38.2%) adherence to AMSTAR-2 criteria and 66.7% (IQR 38.9%) adherence to PRISMA criteria. The overall AMSTAR confidence rating was Critically Low in 15/23 studies, indicating more than one critical flaw. Correlation analysis revealed very high positive association between AMSTAR 2 and PRISMA adherence (+0.97). ROBIS revealed “High” concern regarding methods used to collect data and appraise 17/23 studies (73.9%), and “High” concern regarding synthesis and findings in 14/23 studies (60.9%). Conclusions Transparent reporting of methodology and findings in SRs and MAs is crucial to maintaining research integrity and allowing for accurate interpretation of results. Despite an increasing number of publications in PD, many of these studies fail to meet accepted methodological criteria for reporting. More high quality randomized controlled trials in PD are necessary; while systematic reviews and meta-analyses should focus on these high-quality studies with uniform use of accepted reporting guidelines. Disclosure No