Simhan, J

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 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 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 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 Intracavernosal injection (ICI) therapy for erectile dysfunction (ED) carries a risk of corporal fibrosis, potentially making placement of an inflatable penile prosthesis more difficult. Prostate cancer treatment may also induce corporal fibrosis. Objective To assess whether a history of ICI or prostate cancer treatment is associated with complications following IPP placement. Methods A retrospective cohort study of primary IPP cases from 2016–2021 across 16 institutions. Patients were stratified by history of ICI and between-group differences in risk factors were assessed. Multivariable logistic regression was used to assess for predictors of intraoperative complications, postoperative non-infectious complications and postoperative infection. Results A total of 2540 patients met inclusion criteria of which 781 (30.8%) had a history of ICI. Patients with a history of ICI tended to be older (mean 63 vs 64 years, p=0.002) and were more likely to have history of radical prostatectomy (21.0% vs. 32.1%, p<0.001) and/or radiation (5.51% vs 10.9%, p<0.001). On multivariable regression, a history of ICI, prostatectomy, and radiation were all significant predictors of intraoperative complications (OR 2.11, p=0.03; OR 2.27, p=0.03; OR 2.40, p=0.04, respectively). A history of ICI and patient age were predictors of non-infectious postoperative complications (OR 1.44, p=0.02, OR 1.02, p=0.004 respectively)). None of the variables were significant predictors of infection. Conclusions In men undergoing IPP placement, a history of ICI is associated with an increased risk of both intraoperative and postoperative, non-infectious complications. Prostate cancer treatment with radiation or surgery is independently associated with increased risk of intraoperative complications. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: D.O. has served as a consultant for Coloplast, Intuitive Surgical, and Fidelis. P.P. has served as a consultant for Coloplast, Boston Scientific, and Urofill. M.S. has served as a consultant for Boston Scientific and Coloplast. J.S. has served as a consultant for Boston Scientific and Coloplast. F.A.Y. has served as a consultant for Coloplast, Cynosure, Antares Pharma, Clarus Pharmaceuticals, and Acerus Pharma. M.S.G. has served as a consultant for Coloplast. The other authors disclose no conflicts.

Abstract Introduction Inflatable penile prosthesis (IPP) placement is associated with high postoperative patient satisfaction. Patients often express concerns about postoperative penile length. There is scant evidence in the literature of clinical and surgical factors that predict IPP length. Objective To evaluate predictors of cylinder length for men undergoing primary IPP placement in a large multicenter cohort. Methods Patients undergoing primary IPP placement for treatment of erectile dysfunction at 16 high-volume implant centers were included. All patients had preoperative demographics, surgical characteristics, and device length retrospectively collected at their respective institutions and combined for analysis. Descriptive statistics were reported for the full group. Univariate analysis was utilized to isolate variables significantly associated with device length and all variables reaching p<0.1 were included in linear regression modeling. Results 3,953 men underwent primary IPP placement. The mean age was 61.8±10.4 years and BMI was 29.8±4.2 kg/m2. The mean total device length was 20.6±2.1cm. 1291 (32.7%) had diabetes mellitus, 641 (16.2%) were smokers, 705 (17.8%) had a prior radical prostatectomy, 195 (4.9%) had prior radiation, 549 (13.9%) had Peyronie’s disease, and 884 (22.4%) had a history of intracavernosal injections. In univariate analysis, BMI (B=0.05, 95%CI 0.04 to 0.07, p<0.001), a history of Peyronie’s disease (20.4 vs 20.6cm, p=0.02), and use of intracavernosal injection (20.7 v 20.9cm, p=0.02) were predictors of shorter total device length. Use of rear tip extenders (20.7 v 20.0cm, p<0.001), penoscrotal approach (21.0 v 20.3, p<0.001), and single corporal dilation (20.8 v 20.4cm, p<0.001) were associated with longer length. In multivariable analysis, a history of Peyronie’s disease (B=-0.29, 95%CI -0.47 to -0.11, p=0.002) and greater BMI (B=0.05, 95%CI 0.03 to 0.07, p<0.001) were predictors of shorter total device length. Independent predictors of longer device length were penoscrotal approach (B=-0.85, 95%CI -1.03 to -0.65, p<0.001), rear tip extender use (B=1.00, 95%CI 0.84 to 1.17, p<0.001), and single corporal dilation (B=-0.5, 95%CI -0.67 to -0.34, p<0.001). Conclusions In this series, Peyronie’s disease and greater BMI are independent predictors of shorter IPP device length, while use of rear tip extenders, single corporal dilation, and penoscrotal approach are independent predictors of longer device length. These results are important in counseling patients regarding expectations of postoperative length. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Intuitive Surgical, Fidelis, Urofill, Boston Scientific, Endo Pharma, Coloplast, Cynosure, Antares Pharma, Clarus Pharmaceuticals, Acerus Pharma

Abstract Introduction Predictors of intraoperative corporal perforation and delayed cylinder complications in inflatable penile prosthesis (IPP) placement have not been well-delineated in the literature. Inflatable penile prosthesis (IPP) can offer high satisfaction rates of patients, but this procedure is not without complications that can be encountered intraoperatively and postoperatively. Particularly, predictors of intraoperative corporal perforation and delayed cylinder complications in IPP placement have not been well-delineated in the literature. Objective We evaluated our retrospective multi-institutional database of IPP surgeries performed by expert implant surgeons to identify risk factors that are predictive of the development of these non-infectious complications. Methods IPP cases performed by sixteen international implanters from 2016-2021 were identified. All primary and revision cases were included. Salvage cases for infection were excluded. Demographic characteristics, intraoperative variables, and postoperative outcomes were assessed. Poor corporal integrity (PCI) was defined as intraoperative corporal complications (proximal and/or distal perforation of the corpora, corporal crossover) or postoperative corporal complications (cylinder erosion, extrusion, impending erosion, or deformity). Risk factor analysis and multivariate analysis were performed to identify predictors of PCI. Results A total of 5406 IPP cases across 16 separate institutions were assessed. There were 163 (3.0%, mean age 64) cases of PCI. Of the 156 complications that occurred, 101 (64.7%) occurred intraoperatively, while 55 (35.3%) occurred postoperatively. The rates of diabetes (p=0.669), vascular disease (p=0.054), and history of intracavernosal injections (p=0.111) all had no statistically significant effect on corporal integrity. Patients with PCI tended to have hypertension (p=0.045), current smoking (p=0.03), history of IPP infection (p<0.001), and history of shunt for priapism (p<0.001). On multivariate analysis, predictors of PCI include hypertension (OR 1.64 (1.09-2.47), p=0.018), history of IPP infection (OR 4.41 (2.52-7.84), p<0.001), and age (OR 1.02 (1.00-1.04), p=0.027). Obesity was found to be protective (OR 0.63 (0.42-0.95), p=0.027). Conclusions Our multicenter analysis found that hypertension, current smoking, history of IPP infection and age were risk factors for complications associated with poor corporal integrity. Recognizing these risk factors preoperatively can allow for improved patient-specific counseling and changes in surgical strategy to potentially prevent these complications. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast and Boston Scientific.

Abstract Introduction In primary implant patients without significant corporal fibrosis, penile implant surgical technique varies in implementation of either single dilation (SingD) or sequential dilation (SeqD). Vigorous debate exists regarding both methods, but there is no robust evidence supporting one technique over the other in the literature. Objective We compared the rates of intraoperative complications and postoperative outcomes from a large international database of inflatable penile prostheses (IPP) performed by expert implant surgeons to determine if there were any significant differences in rates between SingD and SeqD. Methods We analyzed IPP cases performed by international implanters from 2016-2021. All primary implant cases were included, while revision cases, salvage operations, and patients with evidence of corporal fibrosis were excluded. Intraoperative complications and postoperative noninfectious outcomes were assessed between the two groups. These included proximal/distal perforation and cylinder crossover. Results After exclusion based on aforementioned criteria, we identified 3045 patients who underwent IPP. After 1:1 propensity matching of both groups, we analyzed 572 patients who underwent SingD and 572 patients who underwent SeqD. Between the two groups, more men of non-Caucasian race underwent SingD vs SeqD (p<0.001). There was a significant difference in cylinder length in the SeqD group vs the SingD group (20cm ± 1.5 vs. 20 cm ±2 respectively, p=0.018). There were 8 (0.7%) intraoperative complications in total, 7 in the SeqD group and 1 in the SingD group (p=0.034). Of these intraoperative complications, 3 (37.5%) patients who underwent SeqD sustained a proximal perforation, 3 (37.5%) sustained distal crossover, and 1 (12.5%) sustained proximal crossover. 1 patient (12.5%) with intraoperative complication who underwent SingD sustained a proximal perforation. Postoperatively, 78 (82%) of complications were in the SeqD group and 17 (18%) in the SingD group (p<0.001). Of these postoperative complications, there were 15 patients with bleeding or hematoma, of which 14 were in the SeqD group vs 1 in the SingD group (p<0.001). Of the 35 patients who were noted to have device-related malfunction, 29 underwent SeqD and 6 underwent SingD (p<0.001). Postoperative complications were more related to technical error in the SeqD vs the SingD group (11 patients and 1 patient respectively, p<0.011). On multivariate analysis, prior radical prostatectomy was predictive of intraoperative complications (OR 4.59 with IQR 1.39-15.16, p=0.024), while larger cylinder size seemed to be protective (OR 0.66 with IQR 0.50-0.89, p=0.006). On multivariate analysis, SeqD was predictive of postoperative complications (5.16 with IQR 3.01-8.83, p<0.001), as was history of priapism (4.15 with IQR 1.30-13.29, p=0.017). Patients who undergo SeqD may be calibrated by the surgeon to have more complex corpora, which could explain higher complication rates. We identified 3045 patients who underwent IPP. Conclusions In our international multicenter assessment of primary IPPs without corporal fibrosis performed by expert surgeons, patients undergoing single dilation appear to have slight benefit in total cylinder length. Sequential dilation may confer greater risk of intraoperative and postoperative complications, including bleeding and hematoma. Single dilation is a safe technique for primary inflatable penile prosthesis. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast and Boston Scientific

Abstract Introduction The American Urological Association (AUA) recommendations on antibiotic prophylaxis in penile implant surgery are based on low quality evidence and expert opinion. Recent evidence suggests the recommended regimens may be suboptimal. Objective To determine if the AUA recommended antibiotic regimen (vancomycin + gentamicin) for primary penile implant surgery is associated with a higher infection risk than non-standard regimens. Methods We performed a multicenter, retrospective cohort study of patients undergoing primary IPP surgery. Patients undergoing revision surgery or with a history of IPP placement were excluded. Additionally, patients who underwent concomitant procedures for Peyronie’s disease or stress urinary incontinence were excluded. Patients were divided into those receiving standard AUA antibiotic prophylaxis (vancomycin + gentamicin) and those receiving any other (non-standard) antibiotic prophylaxis. The time to postoperative device explanation due to infection via a Cox regression model, the microorganisms involved, and the management of patients with device infection were evaluated. A subgroup analysis to identify the appropriate dosage of gentamicin was also performed. Results 4,161 patients underwent primary IPP placement (2,411 received vancomycin + gentamicin and 1,750 received other regimens). The infection rate was similar between groups, 1.0 vs 1.2% for standard vs non-standard prophylaxis. In the multivariate Cox regression analysis, the use of vancomycin + gentamicin (HR: 2.74, 95%CI: 1.38-5.41, p=0.004) and diabetes (HR: 1.87, 95%CI: 1.03-3.39, p=0.04) were significantly associated with higher risk of device explantation due to infection. Concomitant infusion of antifungals (HR: 0.08, 95%CI: 0.03-0.19, p<0.001) was associated with lower risk of infection. Staphylococcus aureus and Escherichia coli were the most frequently cultured microorganisms. Device infection was most commonly managed with salvage using a malleable prosthesis (40.4%). In patients of both groups receiving gentamicin as part of perioperative antibiotic prophylaxis, the use of weight-based gentamicin compared to 80 mg gentamicin was associated with similar risk of device explantation due to infection (HR: 2.88, 95% CI: 0.83 to 10, p = 0.1). Conclusions Vancomycin + gentamicin for antibiotic prophylaxis in primary penile implant surgery is independently associated with a higher infection risk than non-standard antibiotic regimens while antifungal use is associated with lower infection risk. There does not appear to be a difference in weight-based vs low dose (80mg) gentamicin on infection risk. Our results further demonstrate the importance of antifungal use in prophylaxis regimens. Additionally, a critical review of the recommended prophylactic regimens is needed. Tailoring individual regimens to local antibiograms may provide the best infection prevention. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Boston Scientific, Antares Pharma, Clarus Therapeutics, Cynosure, Promescent, Sprout, Viome.