(064) Microbial Patterns of Inflatable Penile Prosthesis Infections With Intraoperative 0.05% Chlorhexidine Gluconate: Findings From a Large Multi-Institutional Cohort
Abstract Introduction 0.05% Chlorhexidine Gluconate (CHG) has increasingly been used as an irrigant for inflatable penile prosthesis (IPP) surgery. Recent in vitro data shows mixed results regarding efficacy, but clinical data is lacking. Objective To explore the cultured organisms and infection characteristics of IPP infections with and without intraoperative CHG use from a large multi-institutional cohort. Methods We queried a retrospective multi-institutional database of patients who underwent IPP placement for cases resulting in IPP Infection. We stratified cases by intraoperative use of CHG as an irrigant or dip. We compared patient and infection characteristics using chi squared tests and independent t-tests. Culture data from IPP explant was reviewed for descriptive analysis. Results We identified 70 IPP infections, 43 with intraoperative CHG use. Patient demographics were similar between infection cohorts. (Table 1). Median time to infection was similar, 46.5 days in the CHG cohort and 34 days in the non-CHG cohort (p=0.518). Culture data were available for 57 (81.4%) patients. For CHG IPP infections, 8 had Escherichia coli cultured at time of explant and 6 grew methicillin sensitive Staphylococcus aureus. For non-CHG IPP infections, Staphylococcus epidermidis (4) and Pseudomonas aeruginosa (3) were the most common cultured organisms. A total of nine unique organisms were cultured for both CHG and non-CHG infections. Negative growth cultures were recorded for 2 patients in both the CHG and non-CHG infection groups. (Figure 1) Conclusions In a large, multi-institutional cohort, IPP infections after intraoperative CHG use were associated with a variety of cultured organisms, most commonly Escherichia coli and Methicillin sensitive Staphylococcus aureus. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast: Advisory board, speaker; Endo: Advisory board; Haleon: Advisory board; Halozyme: Advisory board, speaker; Masimo: Intellectual property; Softwave: Advisory board; Sprout: Consultant; Vertica: Research investigator; Xialla: Advisory board.
(046) Collagenase Clostridium Histolyticum for Ventral Curvature of the Penis Due to Peyronie’s Disease: Updated Results From a Noninterventional, Retrospective, Multicenter Study
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.
(036) Irrigation With 0.05% Chlorhexidine Gluconate Associated With Hydrophilic Inflatable Penile Prosthesis Infection: A Large Multi-Institutional Cohort Study
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
Lower urinary tract symptoms and male sexual function: recommendations from the fifth international consultation on sexual medicine (ICSM 2024)
Abstract Introduction Benign prostatic hyperplasia (BPH) is an age-related condition affecting many men. Emerging evidence highlights a strong relationship between BPH, lower urinary tract symptoms (LUTS) and sexual dysfunction, including erectile dysfunction (ED), reduced sexual desire, hormonal imbalances, and ejaculatory dysfunction, warranting a comprehensive approach to diagnosis and management. Objectives This report aims to provide recommendations for identifying and managing sexual dysfunction associated with BPH and LUTS. Methods Based on guidelines from the International Consultation on Sexual Medicine, a literature review was conducted. Recommendations were graded using the Grading of Recommendations Assessment, Development and Evaluation system. Results The association between BPH, LUTS, and sexual dysfunction is significant, with ED, ejaculatory dysfunction, and hypogonadism being common complications. Lifestyle modifications, medical therapies, minimally invasive surgical therapies, prostate artery embolization, and surgeries (eg, Transurethral resection of the prostate, HoLEP, Aquablation) are among the recommended treatments. Each intervention carries varying risks of sexual dysfunction, requiring specific tailored treatment plans. Conclusions BPH/LUTS significantly affect sexual health, emphasizing the need for a multidisciplinary approach to management. Future research should refine diagnostic criteria and develop treatments that minimize sexual side effects. Enhanced education for patients and their partners could improve quality of life and coping mechanisms.
Intraoperative 0.05% Chlorhexidine Gluconate Utilization Is Associated With an Increased Incidence of Infection in Hydrophilic Inflatable Penile Prosthesis Surgery: A Multi-Institutional Cohort Study
(010) UNVEILING THE IMPACT OF BODY MASS INDEX ON OVERALL OUTCOMES OF INFLATABLE PENILE PROSTHESIS PLACEMENT: INSIGHTS FROM AN INTERNATIONAL, MULTI-CENTER INVESTIGATION
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.
A survey to assess practice patterns among clinicians administering collagenase
Clostridium histolyticum
for Peyronie’s disease