Bajic, P

Abstract Introduction 0.05% Chlorhexidine Gluconate (CHG) has gained popularity as an irrigant and dip for inflatable penile prosthesis (IPP) surgery. Prior in vitro data is conflicting on the impact of CHG use with hydrophilic coated devices. Objective We sought to identify possible associations between CHG use and hydrophilic IPP infection rate. Methods We conducted a retrospective cohort study of 2,933 patients undergoing IPP implantation across 14 referral centers. Data collection spanned from January 1, 2017 to March 1, 2024. Each surgeon contributed patients who underwent IPP implantation with CHG used as an irrigant and/or dip as well as an equal number of consecutive control patients without CHG use. The primary outcome was IPP explant for postoperative infection. Univariable analysis was used to compare patient demographics, and logistic regression analysis was performed to assess factors associated with infection. Results Hydrophilic devices were implanted in 2,150 patients. Median follow-up for non-CHG patients was 13 months (IQR 18) and four months (IQR 9) for CHG patients. The incidence of infection with intraoperative CHG use was significantly higher compared to those without CHG use (4.6%, 46/1,001 vs. 2.1%, 24/1,148, p<0.001). On multivariable logistic regression analysis, intraoperative CHG use was associated with infection (OR 2.07, 95% CI 1.24-3.47, p=0.01). Additional variables associated with infection included immunosuppression, prior IPP infection, prior priapism, and revision surgery (p<0.01, Table). On subgroup analyses, the increased infection risk of CHG was most clear when CHG was used as both irrigation and dip (OR 2.03, 95% CI 1.19-3.46, p=0.01) and when CHG was used during revision surgery (OR 3.36, 95% CI 1.15-9.82, p=0.03). Conclusions In a large multi-institutional cohort, intraoperative CHG use was associated with an elevated incidence of hydrophilic IPP infection. Providers may take these findings into consideration when performing IPP surgery with hydrophilic devices, especially during revision surgery. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Intuitive Surgical, Fidelis, Urofill, Boston Scientific, Coloplast, Cynosure, Antares Pharma, Clarus Pharmaceuticals, Acerus Pharma; Endo Pharma

Abstract Introduction Infection following inflatable penile prosthesis (IPP) placement is an uncommon yet serious complication, and its management poses significant clinical challenges. IPP infection management strategies continue to evolve, however, multicenter and robust studies evaluating and describing current practice patterns are lacking. Objective Using a large cohort from tertiary IPP referral centers in the United States to evaluate current infection management practice patterns and to identify factors that could predict the approach to managing IPP infections. Methods We queried a retrospective 14-center multi-institutional database for patients with IPP infections between April 2017 and January 1/2025. Patients were categorized by infection management strategy, which included device explant, malleable salvage, and 3-piece IPP salvage. Patient characteristics were compared using chi-square and independent t-tests. Multinomial analysis was performed to investigate patient and perioperative factors associated with management strategy at the time of infection. Results Among 2,934 cases, 85 (2.9%) patients developed IPP infection at a median of 40 (22-78) days after IPP implantation. Infections occurred after primary IPP surgery in 59 (69%), revision in 25 (29%), and after infection salvaged with IPP in 1 (1%). Infections were managed with device explant in 32 (38%), malleable salvage in 43 (51%), and IPP salvage in 10 (12%). A significantly higher proportion of non-White patients underwent salvage (either with malleable or IPP) compared to White patients (p=0.01). Multinomial regression showed no association between patient and perioperative characteristics and infection management (p>0.05). Conclusions In this multi-institutional cohort of experienced implanters, infections were most commonly managed with malleable salvage. Patient and perioperative factors did not predict management approach, suggesting that the decision between explanation and salvage is primarily driven by individual surgeon preference. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Boston scientific

Abstract Introduction With the growing use of 0.05% Chlorhexidine Gluconate (CHG) as irrigation and dip for inflatable penile prosthesis (IPP) surgery, understanding the possible relationship between CHG use and non-infectious complications is imperative. Such information may guide provider decision-making during implant surgery. Objective We therefore sought to determine whether the use of 0.05% Chlorhexidine Gluconate (CHG) during inflatable penile prosthesis (IPP) surgery was associated with non-infectious wound complications. Methods We performed a multi-institutional retrospective cohort study of patients undergoing IPP surgery from January 2017 to March 2024. The primary outcome was wound complications (ex. rash, wound dehiscence, edema). Secondary outcomes included other non-infectious complications (Table 1). The primary exposure was whether patients received intraoperative CHG either as irrigation or dip. Descriptive comparisons were used to compare CHG and non-CHG cohorts. Univariable logistic regression was utilized to assess if CHG use was associated with any non-infectious complication. Multivariable logistic regression was subsequently performed to assess factors associated with certain non-infectious complications after IPP surgery – controlling for age, body mass index, race, diabetes, and hypertension as covariables. Results Across 2,933 patients, there were 1,573 non-CHG and 1,359 CHG patients. Non-infectious complications occurred in 83 (5%) non-CHG patients and in 65 (5%) CHG patients. Median follow-up was 22 months (IQR 7-59) for non-CHG patients and 8 months (IQR 3-16) for CHG patients. The incidence of wound complications was greater among CHG patients than non-CHG patients (1.0% vs. 0.1%, p<0.01). On univariable logistic regression, CHG use was associated with increased odds of wound complications (OR 7.34, 95% CI 1.65-32.71) but was not associated with any other non-infectious complication (Table 2). On multivariable logistic regression, CHG use remained associated with an increased odds of wound complications (OR 13.86, 95% CI 1.80-106.44). Conclusions Among patients experiencing non-infectious complications after IPP, CHG use during IPP surgery appears to be associated with an increased odds of wound complications. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast Corporation and Boston Scientific

Abstract Introduction While most patients with Peyronie’s disease (PD) present with dorsal or lateral curvature, a significant number have ventral curvature (VC). These patients face limited treatment options, as they were excluded from initial clinical trials of collagenase clostridium histolyticum (CCH) due to safety concerns related to the proximity of the injection site to the urethra. However, urethral involvement is rare, as PD plaques develop in the tunica albuginea rather than the corpus spongiosum surrounding the urethra. Moreover, multiple prospective and retrospective studies have demonstrated favorable outcomes with CCH treatment in men with VC. Objective To evaluate the effectiveness and safety of CCH in men with PD and VC in a multicenter, real-world, retrospective study. Methods This is an ongoing phase 4, multicenter, retrospective review of medical records from 15 US physician sites. Eligible patients consisted of patients who are: age ≥18 years with a diagnosis of VC in PD with a palpable plaque that was treated with CCH from 2014 to the study start date at each site. Patients missing baseline (BL; pretreatment) or final (last measurement within 6 months of final CCH treatment) penile curvature measurements were excluded. Effectiveness endpoints included percentage change in VC from BL to last visit, mean change in VC (in degrees) from BL to last visit, and proportion of patients with ≥30% improvement in VC from BL to last visit. Safety was assessed as proportions of patients reporting treatment-related adverse events (TRAEs) throughout the study period. Results As of April 22, 2025, there were 116 patients with mean (SD) age of 58 (10.3) years who were eligible for analysis. Mean baseline VC decreased from 58 degrees to 37 degrees at last visit (37% improvement). An improvement in VC of ≥30% was seen in 73/116 (63%) of patients, with 81/116 (69.8%) experiencing ≥20% improvement. At least 1 TRAE was reported by 12 (10%) patients. TRAEs were mild-to-moderate in severity in 9 (75%) patients and unknown in 3 patients, with most events (14/17 [82%]) related to injection site reactions. As of the data cut, there were no treatment-related serious or treatment-related severe AEs, no reports of urethral involvement or injury, and no reports of corporal rupture. Conclusions Men with PD who present with ventral curvature represent an underserved patient population. Concerns about potential urethral injury pose a significant barrier to both minimally invasive and surgical treatments, thereby limiting available therapeutic options. These updated results from a multi-institutional real-world clinical cohort align with previous findings, and demonstrate that the clinical effectiveness and safety profile of CCH is consistent with the profile of CCH seen in other clinical presentations of PD. 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 0.05% Chlorhexidine Gluconate (CHG) has gained popularity as an irrigant and dip for inflatable penile prosthesis (IPP) surgery. Prior in vitro data is conflicting on the impact of CHG use with hydrophilic coated devices. Objective We sought to identify possible associations between CHG use and hydrophilic IPP infection rate. Methods We conducted a retrospective cohort study of 2,933 patients undergoing IPP implantation across 14 referral centers. Data collection spanned from January 1, 2017 to March 1, 2024. Each surgeon contributed patients who underwent IPP implantation with CHG used as an irrigant and/or dip as well as an equal number of consecutive control patients without CHG use. The primary outcome was IPP explant for postoperative infection. Univariable analysis was used to compare patient demographics, and logistic regression analysis was performed to assess factors associated with infection. Results Hydrophilic devices were implanted in 2,150 patients. Median follow-up for non-CHG patients was 13 months (IQR 18) and four months (IQR 9) for CHG patients. The incidence of infection with intraoperative CHG use was significantly higher compared to those without CHG use (4.6%, 46/1,001 vs. 2.1%, 24/1,148, p<0.001). On multivariable logistic regression analysis, intraoperative CHG use was associated with infection (OR 2.07, 95% CI 1.24-3.47, p=0.01). Additional variables associated with infection included immunosuppression, prior IPP infection, prior priapism, and revision surgery (p<0.01, Table). On subgroup analyses, the increased infection risk of CHG was most clear when CHG was used as both irrigation and dip (OR 2.03, 95% CI 1.19-3.46, p=0.01) and when CHG was used during revision surgery (OR 3.36, 95% CI 1.15-9.82, p=0.03). Conclusions In a large multi-institutional cohort, intraoperative CHG use was associated with an elevated incidence of hydrophilic IPP infection. Providers may take these findings into consideration when performing IPP surgery with hydrophilic devices, especially during revision surgery. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast Corporation and Boston Scientific

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