Yafi, FA

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 Obesity, defined as an elevated Body Mass Index (BMI) >30, is a prevalent public health concern with far-reaching implications for various medical procedures and outcomes. In the context of inflatable penile prosthesis placement (IPP), where patient well-being and surgical success are of paramount importance, the impact of obesity on postoperative and intraoperative complications warrants thorough investigation. Objective Our study aimed to investigate the impact of BMI on both postoperative and intraoperative complications in an international, multi-institutional cohort of patients who underwent IPP placement. Methods We performed a retrospective chart review of 4398 cases. These cases were divided into two distinct groups based on BMI: less than 30 (n = 2260) and greater than or equal to 30 (n = 2138). The study assessed various surgical factors as well as complications, including overall complications, corporal scarring, incontinence, intraoperative complications, proximal perforation, distal perforation, proximal crossover, distal crossover, and urethral injury. Results Our analysis revealed that there were no statistically significant differences in intraoperative or postoperative complications between the two BMI categories. Notably, proximal corporal measurement was significantly higher for >30 BMI group (9.55 +/−2.18) compared to <30 BMI group (9.14 +/−2.19), (p = < 0.001). The incidence rates for overall complications (30.2% vs. 28.7%; p = 0.164), corporal scarring (18.2% vs. 16.7%; p = 0.36), incontinence (3.53% vs. 3.13%; p = 0.076), intraoperative complications (1.94% vs. 1.68%; p = 0.253), and specific complications all exhibited no significant differences. Similarly, post-operative complications, including both non- infectious (6.99% vs. 6.22%; p = 0.215) and infectious (2.61% vs. 1.87%; p = 0.165) complications, did not significantly vary between BMI categories. Conclusions Our findings indicate that BMI does not exert a statistically significant influence on postoperative and intraoperative complications in the context of high-volume prosthetic urology. In the absence of any other differences between patients of differing BMIs, surgeons may need to be mindful of pump tubing length concerns in obese patients. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Clarus Therapeutics, Antares Pharma, Acerus.

Abstract Introduction Obesity, defined as an elevated Body Mass Index (BMI) >30, is a prevalent public health concern with far-reaching implications for various medical procedures and outcomes. In the context of inflatable penile prosthesis placement (IPP), where patient well-being and surgical success are of paramount importance, the impact of obesity on postoperative and intraoperative complications warrants thorough investigation. Objective We aimed to investigate the impact of BMI on both postoperative and intraoperative complications in an international, multi-institutional cohort of patients who underwent IPP placement. Methods We performed a retrospective chart review of 4,398 cases. These cases were divided into two distinct groups based on BMI: less than 30 (n = 2,260) and greater than or equal to 30 (n = 2,138). The study assessed various surgical factors as well as complications, including overall complications, corporal scarring, incontinence, intraoperative complications, proximal perforation, distal perforation, proximal crossover, distal crossover, and urethral injury. Results Our analysis revealed that there were no statistically significant differences in intraoperative or postoperative complications between the two BMI categories. Notably, proximal corporal measurement was significantly higher for >30 BMI group with 1858 (86.9%) compared to 1919 (84.9%) for <30 BMI group, (p = < 0.001). The incidence rates for overall complications (30.2% vs. 28.7%; p = 0.164), corporal scarring (18.2% vs. 16.7%; p = 0.36), incontinence (3.53% vs. 3.13%; p = 0.076), intraoperative complications (1.94% vs. 1.68%; p = 0.253), and specific complications all exhibited no significant differences. Similarly, post-operative complications, including both non-infectious (6.99% vs. 6.22%; p = 0.215) and infectious (2.61% vs. 1.87%; p = 0.165) complications, did not significantly vary between BMI categories. Conclusions Our findings indicate that BMI does not exert a statistically significant influence on postoperative and intraoperative complications in the context of high-volume prosthetic urology. In the absence of any other differences between patients of differing BMIs, the IPP industry may need to consider device specific alterations with pump tubing length in obese patients. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Clarus Therapeutics, Antares Pharma, Acerus.

Abstract Introduction Inflatable penile prosthesis (IPP) surgery is a well-established treatment for erectile dysfunction (ED). There is little information in the literature regarding the utilization of perioperative antimicrobial prophylaxis in primary and revision IPP surgeries. Objective We investigated the patterns of perioperative antimicrobial prophylaxis among a large multinational cohort of primary and revision IPP surgeries. Methods We conducted a retrospective analysis of 5,400 patients (4,187 primary IPP patients and 849 revision IPP patients) from our Prosthetic Urology Multi-Institutional Partnership (PUMP) institutions. Usage data for intravenous (IV), preoperative oral, and postoperative oral antimicrobials were analyzed. We specifically assessed patient profiles, antimicrobial selection, and antimicrobial duration. Multivariate statistical analyses were conducted to identify significant variations between primary and revision surgeries. Results For patients undergoing primary IPP placement, 81.9% received IV antibiotics for <24 hours whereas 18.1% received IV antibiotics for >24 hours. Preoperative oral antimicrobials were used in 59.4% of patients and 99.4% received postoperative oral antimicrobials. The overall infection rate for primary implants was 2%. Notably, quinolone administration shows a higher postoperative infection rate (11.4%) compared to gentamicin (1.9%), cephalosporin (0%), and vancomycin (1.0%). Multivariable regression analysis identifies factors such as a history of infection, diabetes, and priapism as predictors for postoperative infections. Furthermore, the study finds that perioperative antifungal use is associated with a decreased risk of infection. Conclusions This study provides valuable insights into the patterns of perioperative antimicrobial prophylaxis. Duration, type, and route of antibiotics given preoperatively or postoperatively do not affect postoperative infection rates among high volume prosthetic urologists. Giving IV antibiotics for more than 24 hours does not affect postoperative infection. Perioperative antifungals are a protective factor. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Clarus Therapeutics, Antares Pharma, Acerus.

Abstract Introduction The utilization of rear tip extenders (RTE) is often imperative during Inflatable Penile Prosthesis (IPP) placement. The impact of RTE on perioperative morbidity of IPP surgery is underexplored. Objective In this study, we assess intraoperative and postoperative outcomes among patients undergoing primary IPP implantation with or without RTE. Methods We performed a multicenter, retrospective analysis of men undergoing primary IPP placement between July 2016 and July 2021. A total of 4308 patients were identified, of which 2963 had no RTE and 1345 had RTE. After 1:1 propensity score matching for all confounding variables, 840 patients without RTE were compared to patients with RTE for intraoperative and postoperative outcomes. Chi-square and Mann–Whitney tests were used for statistical analysis for categorial and continuous variables respectively. For multivariable analysis, we used a forward stepwise model and included significant variables found on preoperative characteristics of patients. Kaplan–Meier time to event analysis were compared with Mantel-Cox log-rank test. Results Patients with RTE use had more postoperative complications (9.6% vs 5.2%, p < 0.001). More specifically, RTE patients had more episodes of postoperative hematoma and bleeding (2.0% vs 0.7%, p = 0.033), device malfunction (2.7% vs 1.8%, p = 0.006), and glans-related complications (0.8% vs 0, p = 0.015). On multivariable analysis, use of RTE (OR 1.58, 95% CI 1.07-2.34, p = 0.021), AMS 700 series device (OR 1.93, 95% CI 1.27-2.94, p = 0.002), penoscrotal approach (OR 2.60, 95% CI 1.61-4.18, p < 0.001), and older age (OR 1.02, 95% CI 1.00-1.04, p = 0.035) were associated with increased risk of postoperative complications. Patients with RTE use had increased rate of postoperative IPP revision (5.0% vs 2.1%, p = 0.002). The use of RTE (OR 1.71, 95% CI 1.00-2.90, p = 0.046), AMS 700 series device (OR 1.73, 95% CI 1.01-2.97, p = 0.048), penoscrotal approach (OR 3.16, 95% CI 1.63-6.17, p < 0.001), and history of Peyronie’s disease (OR 2.24, 95% CI 1.31-3.82, p = 0.003) were associated with increased risk of postoperative IPP revision or explantation. On Kaplan–Meier analysis, use of RTE was associated with increased risk of postoperative complications and IPP revision or explantation within 48 months (log rank p = 0.001 and p = 0.002 respectively). Conclusions In this large multi-institutional cohort, patients with RTE experienced more hematoma, device malfunctioning, and glans related post operative complications. The use of RTE is an independent predictor of post-operative complications and IPP revision or explanation. Disclosure No.

Abstract Introduction Inflatable penile prosthesis (IPP) surgery is a well-established treatment for erectile dysfunction (ED). There is little information in the literature regarding the utilization of perioperative antimicrobial prophylaxis in primary and revision IPP surgeries. Objective We investigated the patterns of perioperative antimicrobial prophylaxis among a large multinational cohort of primary and revision IPP surgeries. Methods We conducted a retrospective analysis of 5400 patients (4187 primary IPP patients and 849 revision IPP patients) from our Prosthetic Urology Multi-Institutional Partnership (PUMP) institutions. Usage data for intravenous (IV), preoperative oral, and postoperative oral antimicrobials were analyzed. We specifically assessed patient profiles, antimicrobial selection, and antimicrobial duration. Multivariate statistical analyses were conducted to identify significant variations between primary and revision surgeries. Results For patients undergoing primary IPP placement, 81.9% received IV antibiotics for <24 hours whereas 18.1% received IV antibiotics for >24 hours. Preoperative oral antimicrobials were used in 59.4% of patients and 99.4% received postoperative oral antimicrobials. The overall infection rate for primary implants was 2%. Notably, quinolone administration shows a higher postoperative infection rate (11.4%) compared to gentamicin (1.9%), cephalosporin (0%), and vancomycin (1.0%). Multivariable regression analysis identifies factors such as a history of infection, diabetes, and priapism as predictors for postoperative infections. Furthermore, the study finds that perioperative antifungal use is associated with a decreased risk of infection. Conclusions This study provides valuable insights into the patterns of perioperative antimicrobial prophylaxis. Duration, type, and route of antibiotics given preoperatively or postoperatively do not affect postoperative infection rates among high volume prosthetic urologists. Giving IV antibiotics for more than 24 hours does not affect postoperative infection. Perioperative antifungals are a protective factor. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Clarus Therapeutics, Antares Pharma, Acerus.

Abstract Introduction High medication costs for vaginal estrogen may create a barrier for patients seeking treatment for numerous urinary and vaginal symptoms and lead to poor medication adherence. The Mark Cuban Cost Plus Drug Company (CPD) and GoodRx tools offer patients a method to purchase prescription medications at a discount, which may lead to improved medication adherence and decreased national expenditures on such medications. Objective To compare the pricing of vaginal estrogen as advertised by retail pharmacies, Medicare, and discount listings through CPD and GoodRx. Methods A review of publicly available data from CPD and GoodRx was performed to obtain listed retail and discounted prices for Estrace (topical), Vagifem (tablet), and Premarin (topical). GoodRx prices were obtained using prices from Costco, CVS, Walgreens, and Walmart pharmacies in the most from populous zip code from each of the 3 most populous U.S. states: California, New York, and Texas. Prices were adjusted to account for dosage and prescribed quantity to estimate an average cost per dosage unit ($/adu). The Medicare Part D Drug Spending and Utilization data from 2021 were used to report the average spending per dosage unit and total expenditure for each of the listed medications. These data were compared to create an estimate of average national savings after use of CPD and/or GoodRx. Results Average spending per dosage unit for Estrace, Vagifem, and Premarin was lesser when discount tools were used (0.50 $/adu, 3.75 $/adu, and 4.30 $/adu respectively), compared to Medicare pricing (6.14 $/adu, 20.95 $/adu, and 10.10 $/adu respectively) or retail pricing (3.14 $/adu, 10.19 $/adu, and 5.43 $/adu respectively). When adjusted for total dosage units, use of CPD over Medicare pricing for the three medications would result in a combined annual national saving of $64.2M. Use of either CPD or GoodRx compared to retail pricing would similarly result in a combined annual national saving of $39.2M. Conclusions The utilization of CPD and GoodRx in the prescription of vaginal estrogen led to a substantial national average cost savings when compared to retail and Medicare pricing. CPD and GoodRx may offer a way to decrease the cost burden for patients seeking treatment for urinary and vaginal symptoms and significantly reduce national expenditures on medications. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: The utilization of CPD and GoodRx in the prescription of vaginal estrogen led to a substantial national average cost savings when compared to retail and Medicare pricing. CPD and GoodRx may offer a way to decrease the cost burden for patients seeking treatment for urinary and vaginal symptoms and significantly reduce national expenditures on medications.

Abstract Introduction The Mark Cuban Cost Plus Drug Company (CPD) is an online retailer launched in January 2022 that sells generic prescription medications directly to consumers at cost of ingredients and manufacturing plus a fixed 15% margin in addition to a small pharmacy dispensing fee and shipping fee. GoodRx is an online tool which offers coupons redeemable at pharmacies for discounts on prescription medications. The combination of these two tools offers physicians a way to provide prescription medications to patients at lower costs, which may lead to improved medication adherence and lower medication expenditures nationally. Objective To compare the cost of various erectile dysfunction medications when purchased through retail pharmacies, reimbursed through Medicare, or obtained utilizing CPD and GoodRx. Methods A review of publicly available data from CPD and GoodRx was performed to obtain average retail and discounted prices for generic sildenafil, tadalafil, and vardenafil. GoodRx prices were obtained using prices from Costco, CVS, Walgreens, and Walmart pharmacies in the most from populous zip code from each of the 3 most populous U.S. states: California, New York, and Texas. Prices were adjusted to account for dosage and prescribed quantity to estimate an average cost per dosage unit ($/adu). The Medicare Part D Drug Spending and Utilization data from 2021 were used to report the average spending per dosage unit and total expenditure for each of the listed medications. These data were compared to create an estimate of average national savings after use of CPD or GoodRx. Results Average spending per dosage unit for sildenafil, tadalafil, and vardenafil was less when GoodRx or CPD were used (0.28 $/adu, 0.31 $/adu, and 6.17 $/adu respectively), compared to Medicare pricing (2.14 $/adu, 8.08 $/adu, and 27.84 $/adu respectively) or retail pricing (0.52 $/adu, 2.82 $/adu, and 8.35 $/adu respectively). When adjusted for total dosage units, use of CPD over Medicare pricing for the three medications would result in a combined annual national saving of $149M. Use of either CPD or GoodRx compared to retail pricing would similarly result in a combined annual nation saving of $40M. Conclusions The utilization of CPD and GoodRx in the prescription of common erectile dysfunction medications may lead to significant reductions in pricing compared to retail and Medicare estimates. Knowledge of these prescription tools may lead to significant reductions in national expenditures on medications and decreased cost burden for patients seeking treatment. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Advisory board and speaker for Coloplast; consultant for Cynosure; advisory board and speaker for Halozyme; intellectual property with Masimo; advisory board for Promescent; consultant for Sprout; advisory board for Xialla.