Ziegelmann, M

Abstract Introduction Clostridium Collagenase Histolyticum (CCH) is the only-FDA approved non-surgical, intralesional option for men with Peyronie’s disease. However, little is known regarding practice patterns of CCH providers due to lack of standardized protocols. Objective To evaluate practice patterns for providers approved to administer CCH to treat Peyronie’s disease (PD), this study was conducted. Methods The “Find a Xiaflex-Trained Urologist” search tool on the Endo International patient-facing website was utilized to identify clinicians offering CCH injections in the United States. A 24-question survey was mailed to these providers with topics including provider type, years in practice, therapies offered, and patient evaluation was distributed to providers on patient-facing Endo International Xiaflex Find a Provider web-based tool. Results 63 responses were obtained, including 41% fellowship-trained urologists (FTU), 40% non-fellowship-trained urologists (NFTU), 14% advanced practice providers, and 5% un-specified. Prior to therapy, over 63% of providers performed in-office assessment of an erect penis while only 35% obtained ultrasound. 32% always and 36% never performed an artificial erection prior to administering CCH. Plaques were most identified by palpation or patient-provided direction with penile modeling and traction the most common adjuncts. When comparing NFTU to FTU, there was no difference in volume of PD patients with 60% examining fewer than 10 per month. FTU were more likely to offer traction (p = 0.002), plaque incision/excision and grafting (p = 0.005), increase time between injections (p = 0.012), and less likely to encourage penetrative intercourse between cycles (p = 0.016). The incidence of post-operative hematomas or suspected corporal rupture was not significantly different, although FTUs were more likely to conservatively manage rupture. Conclusions Variability exists in provider practice patterns surrounding CCH injections with most evaluating less than 10 patients with PD per month. This calls to attention the need for evaluation of techniques, patient outcomes, and standardization of care. 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: Endo Pharmaceuticals.

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 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