Inflatable Penile Prosthesis Surgery Research Articles

Penoscrotal inflatable penile prosthesis recipients often fully recover from pain at two weeks following placement.

The symptoms and duration of pain following inflatable penile prosthesis (IPP) surgery remains poorly understood. We characterize postoperative pain following penoscrotal 3-piece inflatable penile prosthesis placement in patients managed with a standardized pain management protocol. This is a single-center prospective analysis of 96 virginal penoscrotal 3-piece IPP recipients (9/2019 to 9/2021) excluding patients with chronic pain, IPPs performed with alternative approaches or concomitantly with other surgeries and those with infections. Standardized pain questionnaire was performed by phone on post-operative day (POD) 2, 7, 14, and 30. The primary outcome was self-reported pain scores, measured by pain score 0-10 (0 = no pain, 10 = unbearable, "worst pain you have ever felt") at various locations (incision, penile, scrotal, abdominal) over the first 30 days postoperatively. A majority of pain reported was outside the scrotal area with 67.6% of complaints in the shaft, glans, abdomen and incision. From POD2 to POD30, there was a significant decrease in severe pain from 46.2 to 11.1% (p = 0.05) with an increase in mild pain from 23.1 to 62.4% (p = 0.05). Roughly half of the participants (47.9%, n = 46) reported no pain by POD14. Penoscrotal IPP recipients often fully recover from pain at the two-week period following surgery and those with lingering discomfort predominantly complain of penile shaft and glans pain.

Does climate impact inflatable penile prosthesis infection (IPP) risk? Assessment of temperature and dew point on IPP infections.

Variations in climate have been associated with a greater risk of surgical site infections, urinary tract infections, and changes in the skin microbiome; however, limited data exist on the impact of climate on inflatable penile prosthesis (IPP) infections. We sought to evaluate the impact of climate on the risk of IPP infections in a large international, multicenter cohort. We performed a multi-institutional, retrospective study of patients undergoing IPP surgery. We then evaluated whether the month or season, during which surgery was performed, affected device infections. Implant infections were defined as infections requiring device explantation. A univariate logistic regression analysis was undertaken. Our primary outcome was implant infection. A total of 5289 patients with a mean age of 62.2 ± 10.8years received IPP placement. There was a fairly even distribution of implants performed in each season. A total of 103 (1.9%) infections were recorded. There were 32 (31.1%) IPP infections in patients who underwent surgery in the summer, followed by 28 (27.2%) in the winter, 26 (25.2%) in the spring, and 17 (16.5%) in the fall. No statistically significant differences were recorded in terms of season (P = .19) and month (P = .29). The mean daily temperature (P = .43), dew point (P = .43), and humidity (P = .92) at the time of IPP placement was not associated with infection. These findings provide reassurance to prosthetic urologists that infection reduction strategies do not need to be tailored to local climate. Climate data were not directly recorded for each hospital, but rather based on the monthly averages in the city where the surgery was performed. The climate at time of IPP placement and time of year of surgery is not associated with IPP infection risk.

(017) Comparing Complication Rates and Continence Control in Concurrent Dual Implantation of Inflatable Penile Prosthesis/Artificial Urinary Sphincter vs. Inflatable Penile Prosthesis/Male Sling: An Updated Comparative Pilot Study

Abstract Introduction Artificial urinary sphincter (AUS) and bulbourethral male sling are used frequently in the management of post prostatectomy urinary incontinence (UI) in men. Some surgeons used to combine an inflatable Penile Prosthesis (IPP) procedure at the same setting to treat concurrent erectile dysfunction (ED). Recent clinical trials have aimed to determine the comparative effectiveness between the male sling and the artificial urinary sphincter (AUS) in men with urodynamic stress urinary incontinence (SUI) after prostate surgery, focusing on non-inferiority. Objective We aim to compare continence control and complications rates in patients who underwent bulbourethral slings or AUS during IPP surgery via perineal approach. Methods A retrospective chart review was done in a large tertiary center. Post prostatectomy patients who underwent perineal dual implantation IPP and AUS or bulbourethral sling for ED and UI purposes, between 2014 and 2022 were included. Clinical data, patients’ demographics were retrieved. Post-operative outcomes with regards to IPP complication rates, revision rates for IPP/ AUS / Male sling, and continence control at 6 weeks, 6 months and 1 year were collected and included in the analysis. Continence control rates were assessed by the number of pads used per day on subsequent follow up visits for both groups. Results A total of 32 patients met the inclusion criteria. 16 Patients underwent synchronous IPP and AUS insertion, whereas another 16 patients underwent IPP with bulbourethral sling procedure. Patient demographics, median follow up & complication rates are summarized below in Table 1. In both groups the procedure was done through a perineal approach. There was no significant difference in baseline data among groups. Complication rates between AUS devices and bulbourethral slings showed no statistically significant differences (12.5% vs 6.25% p= 0.22 respectively). Infection rates and need for revision also did not show any statistically significant differences. With regards to post-operative continence rates, both groups had comparable outcome with no significant differences (P = 0.81). Upon the 6 months follow up visit, the AUS group, 56% were pad free, 19% used 1 pad per day, 19% used 2 pads per day, and 6% used 3 pads or more per day, while in the sling group, 50% were pad free, 25% used 1 pad per day, 19% used 2 pads per day, and 6% used 3 pads or more per day. Patients were followed for a total of 1 year after the surgery. Conclusions The combined insertion of IPP with either AUS or sling procedures has comparable outcomes with regards to continence rate and device- related complications. Each incontinence surgery should be chosen according to surgeon experience and specific patient indications. Further prospective studies on a larger sample of patients with longer follow up period are needed to solidify these findings and will guide patient's decision and preference for incontinence surgeries along with IPP once indicated. Disclosure No.

(020) Does Climate Impact IPP Infection Risk? Assessment of Temperature and Dew Point on IPP Infections

Abstract Introduction Variations in climate have been associated with greater risk of surgical site infections, urinary tract infections, and changes in the skin microbiome. Although the pathogenic organisms for inflatable penile prosthesis (IPP) infections are commonly skin flora, limited data exists on the impact of climate on IPP infections. We sought to evaluate the impact of climate on the pathogenic organisms of IPP infections in a large international, multicenter cohort. Objectives To assess whether the time of the year, during which surgery was performed, affected device infections. Methods We performed a multi-institutional, retrospective study of patients undergoing IPP surgery. We then evaluated whether the month or season, during which surgery was performed, affected device infections. Additionally, we assessed the effect of temperature, dew point, and humidity on the microorganisms involved in implant infections. Infections were classified as Gram positive, Gram negative, or mixed (including a combination of Gram positive, Gram negative, and/or fungi). A univariate logistic regression analysis was undertaken. Results A total of 5289 patients with a mean age of 62.2 ± 10.8 years received IPP placement. A total of 103 (1.9%) infections were recorded. Overall, 38 (36.9%) infections were caused by Gram positive bacteria. An increase in temperature was associated with a higher risk of infection with Gram positive bacteria (OR: 1.03, 95% CI: 1 to 1.07, p = 0.035). No statistically significant differences were recorded in terms of season (p = 0.19) and month (p = 0.29). Conclusion Higher temperature is associated with greater risk of Gram positive infections whereas lower temperature and dew point were associated with a higher risk of mixed infections. These findings may help surgeons tailor antibiotic prophylaxis based on local climate. Disclosure No.

(047) Practice Patterns for Inflatable Penile Prosthesis Revisions Within a Large Fully Integrated Healthcare System

Abstract Introduction Revision Inflatable Penile Prosthesis (IPP) surgery is considered to be more surgically complex than virgin IPP implantation. Not all implanters perform revision surgery. Moreover, there is a paucity of data on the practice patterns of implanters regarding revision surgery. We aimed to evaluate the practice patterns of revision vs virgin inflatable penile prosthesis implantation within a large fully integrated healthcare system. Objective We aimed to evaluate the practice patterns of revision vs virgin inflatable penile prosthesis implantation within a large fully integrated healthcare system. Methods After Institutional Review Board approval, we reviewed the Kaiser Permanente Southern California (KPSC) database for all IPPs implanted within a 10 year period (2009-2019) at 15 medical centers. Patients undergoing virgin and revision penile prosthetic surgery were identified using CPT codes. Preoperative patient characteristics, intra-operative and postoperative outcomes were obtained via retrospective chart review. Univariate and multi-variate logistic regressions were performed. Results Between 2009 and 2019, 1,093 IPP surgeries were performed at KPSC, 115 of which were revision cases (10.5%). A total of 66 surgeons performed at least 1 IPP surgery (median=5 IPPs/surgeon, Range 1-160). Yet, revision IPPs were performed by only 32 surgeons, of which 4 surgeons were responsible for 61 of the revisions (p<0.05). When compared to virgin cases, revision cases had a longer median operative time (121 mins vs 96 mins, p <0.001), were more likely to be a penoscrotal approach (OR 3.17, p<0.05), have an ectopic reservoir placement (63.5% vs 35.7%, p<0.001), and significantly less likely to have a concurrent procedure done (OR 0.21, p<0.05) all based on multivariable logistic regression analysis. Nevertheless, device infection rates were not significantly different (revision 2.6% vs virgin 4.5%, p=0.43). There was no difference in intra-operative complications between revision and virgin cases (2.6% vs 1.4%, P=0.5). Median follow up was 4.1 years. Conclusions To our knowledge, this is one the largest series of revision IPPs done at multiple centers among more than 30 surgeons with long term follow up. Our data suggests that most IPP revisions are done by a select few implanters. Despite longer operative times, device infection rates were less than virgin cases, though not statistically significant. Within our large fully integrated healthcare system, in the hands of high-volume revision implanters, device infection and intraoperative complications rates remain quite low. These findings could help implanters counsel future patients regarding revision IPP surgery. Disclosure No.

(171) The Effects of Pretreatment with Xiaflex on Penile Curvature Correction with Manual Modeling During and After IPP placement

Abstract Introduction There are a variety of treatment modalities available to treat Peyronie’s disease (PD), including collagenase clostridium histolyticum (Xiaflex) injections. Patients with concomitant erectile dysfunction (ED) and PD are best served by insertion of an inflatable penile prosthesis (IPP) in order to adequately treat both conditions. Many PD patients may undergo other PD treatments, including Xiaflex, prior to IPP implantation. There are multiple methods of curvature treatment during IPP surgery, and manual modeling is the predominant method in our practice. Little data exists regarding whether Xiaflex treatments prior to IPP placement influence changes in penile curvature during and after IPP surgery with manual modeling. Objective The primary objectives were assessing the impact of pre-treatment with Xiaflex on penile curvature immediately after IPP implantation and after manual modeling. The secondary objective was change in penile curvature post-operatively. Methods All IPP patients with known preoperative penile curvature with and without a history of Xiaflex injections undergoing IPP placement by a single surgeon from January 2017 to June 2023 were included in this IRB-approved (IRB 00031589) retrospective series. All patients had a 3-piece Coloplast Titan Touch IPP (Coloplast, Minneapolis, MN, USA) ranging 16-24cm in length (mean 19.8 ± 1.9cm) with 0-3cm rear tips (mean 1.4 ± 0.9cm). Goniometer was used to assess curvature during preoperative intracavernosal injection and duplex Doppler ultrasound, at multiple points intraoperatively, and postoperatively at 2 weeks, 6 weeks, and 6 months. Biplanar curvatures were recorded as primary and secondary values. SPSS (IBM, Armonk, NY, UA) was used for statistical analyses, which included t-tests, chi-squared tests, and ANOVA. Results Sixty-one patients were included. Preoperative curvature was 35° ± 17° (10° to 70°) for the Xiaflex cohort (n=11) and 41° ± 15° (20° to 80°) for the Xiaflex naïve cohort (n=50). At the time of IPP placement, patients previously treated with Xiaflex had a 19° ± 12° absolute reduction in primary penile curvatures, corresponding to a 45% ± 36% improvement (25° reduction to 5° worsening), while Xiaflex naïve patients had a 20° ± 13° absolute reduction and 54% ± 23% improvement (50° reduction to no change). Similar mean curvature reductions were seen with IPP placement in primary dorsal curves in the Xiaflex cohort (n=7, 21° ± 4°, 51% ± 12%, 25° to 15° reduction) and Xiaflex naïve cohort (n=24, 21° ± 9°, 51% ± 22%, 40° to 5° reduction). There was little difference in change in curvature after modeling between the Xiaflex (11° ± 3°, 63% ± 23%, 15° to 5° reduction) and Xiaflex naïve patients (14° ± 9°, 70% ± 20%, 40° reduction to 5° worsening). Interval assessments postoperatively were also comparable. Sample size precluded assessment of statistical significance among groups. Conclusions Preoperative treatment of PD with Xiaflex does not impede nor significantly improve curvature correction with IPP implantation and manual modeling. Similar changes in penile curvatures were seen in both groups regardless of curvature direction, modeling, or postoperative interval. In patients with severe PD, Xiaflex may be a useful tool to improve preoperative penile curvatures such that they may be more easily correctable with an IPP. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, MenMD.

(310) Severe Delayed Skin Reaction to Antiseptic Irrigation Solution Managed with Pinch Skin Grafting After Inflatable Penile Prosthesis Surgery: A Case Report

Abstract Introduction Inflatable penile prosthesis (IPP) surgery is a common procedure for treating erectile dysfunction, and skin preparation with antiseptic solutions is a standard practice to reduce infection risk. However, some antiseptic solutions, such as chlorhexidine-based Irrisept, have been associated with severe skin reactions. Several studies have reported cases of contact dermatitis, blistering, and chemical burns following the use of chlorhexidine-based antiseptic solutions before surgery. Objective This case report aims to highlight the potential risk of severe skin reactions when using Irrisept and other chlorhexidine antiseptic solutions during penile prosthesis surgery. It also explores the novel technique of pinch skin autografting used to salvage the implant and achieve successful wound healing after delayed skin necrosis. Methods 61-year-old male with a history of prostate cancer and erectile dysfunction who underwent insertion of an IPP. Results The patient's penile shaft developed blisters 3 weeks post-implantation, which progressed to full-thickness necrosis despite conservative treatment. The distribution and location of the reaction led to the hypothesis that it was caused by the chlorhexidine-based Irrisept antiseptic. The antiseptic solution used copiously throughout the case and 10CC was injected under pressure into the drain which also may explain the reaction observed. The patient underwent wound debridement and was treated with pinch skin autografts from the bilateral thighs. The autografts resulted in 95% epithelialization with excellent cosmetic outcomes with no other complications. To the best of our knowledge, this is the first reported case of Irrisept-induced delayed skin necrosis and the use of pinch skin grafting to salvage the implant after penile prosthesis surgery. Conclusions Skin reactions to Irrisept antiseptic solution during penile prosthesis surgery are rare but can be severe. Surgeons should be cautious and consider alternative skin preparation methods in patients with a history of skin allergies or sensitivities. This case also highlights the potential of pinch skin autografting as a salvage technique for post-IPP skin reactions. A multidisciplinary approach involving reconstructive burn surgeons and specialty wound care teams may be beneficial in optimizing outcomes in such cases. Disclosure No.

(175) Shorter Duration of Postop IPP Inflation Following Manual Modeling May Lead to Curvature Regression

Abstract Introduction Patients with concomitant erectile dysfunction (ED) and PD are best served by insertion of an inflatable penile prosthesis (IPP) in order to adequately treat both conditions. There are multiple methods of curvature treatment during IPP surgery, and manual modeling is the predominant method in our practice. We elect to leave the IPP inflated postoperatively to maintain curvature reduction improvements, but the ideal duration of postoperative inflation for this purpose has not been determined. There is also little data regarding how the duration of postoperative IPP inflation may affect penile curvature. Objective The primary objective was assessing the impact of postoperative IPP inflation on penile curvature postoperatively over time. Methods All IPP patients with known preoperative penile curvature undergoing IPP placement by a single surgeon from January 2017 to June 2023 were included in this IRB-approved (IRB 00031589) retrospective series. All patients received a 3-piece Coloplast Titan Touch IPP (Coloplast, Minneapolis, MN, USA). Goniometer was used to assess curvature during preoperative intracavernosal injection and duplex Doppler ultrasound. All patients followed a standard postoperative follow-up protocol of visits at 2 weeks, 6 weeks and 6 months, although some were also seen sooner than anticipated or with additional unplanned follow-up. Our practice is to leave the device partially (to 60-70%) inflated for2 weeks postoperatively and perform device teaching at 6 weeks postoperatively if feasible. Patients who cannot tolerate device inflation due to pain or other extenuating circumstances are deflated earlier than two weeks. The change in penile curvature, as determined by goniometry at various timepoints, was evaluated relative to the duration of IPP inflation postoperatively. SPSS (IBM, Armonk, NY, UA) was used for statistical analyses, which included t-tests, chi-squared tests, and ANOVA. Results Sixty-one patients were included. The average preoperative penile curvature was 40° ± 16° (0° to 80°). At the time of surgery, all IPPs were left inflated on average 11 ± 5.2 days with device deflation at <2 weeks for 31.3% patients (n=19) and at ≥2 weeks for 68.9% patients (n=42). There was no curvature regression for either group at 2 weeks or 6 months; however, both groups had a subset of patients with worsened curvature at 6 weeks. Penile curvature was worse at 6 weeks for 26.3% (n=5) of patients with a shorter IPP inflation period compared to 12.8% (n=5) of patients with device inflation of at least two weeks. Sample size precluded assessment of statistical significance among groups. Conclusions Patients with IPP deflation <2 weeks had a higher incidence of curvature regression 6 weeks postoperatively compared to patients with IPP deflation ≥2 weeks. Curvature did not regress while device was inflated or between the 6 week and 6 month postoperative visits. Additional studies are needed to elucidate the optimal timeframe for, and degree of, IPP inflation to avoid postoperative penile curvature regression. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast and MenMD.

(220) Does Complication and Continence Rates Differ When Combining Inflatable Penile Prosthesis with Post Prostatectomy Incontinence Procedures Inserted Via Perineal Approach? An Updated Pilot Study

Abstract Introduction Artificial urinary sphincter (AUS) and bulbourethral male sling are used frequently in the management of post prostatectomy urinary incontinence (UI) in men. Some surgeons used to combine an inflatable Penile Prosthesis (IPP) procedure at the same setting to treat concurrent erectile dysfunction (ED). Recent clinical trials have aimed to determine the comparative effectiveness between the male sling and the artificial urinary sphincter (AUS) in men with urodynamic stress urinary incontinence (SUI) after prostate surgery, focusing on non-inferiority. Objective We aim to compare continence control and complications rates in patients who underwent bulbourethral slings or AUS during IPP surgery via perineal approach. Methods A retrospective chart review was done in a large tertiary center. Post prostatectomy patients who underwent perineal dual implantation IPP and AUS or bulbourethral sling for ED and UI purposes, between 2014 and 2022 were included. Clinical data, patients’ demographics were retrieved. Post-operative outcomes with regards to IPP complication rates, revision rates for IPP/ AUS / Male sling, and continence control at 6 weeks, 6 months and 1 year were collected and included in the analysis. Continence control rates were assessed by the number of pads used per day on subsequent follow up visits for both groups. Results A total of 32 patients met the inclusion criteria. 16 Patients underwent synchronous IPP and AUS insertion, whereas another 16 patients underwent IPP with bulbourethral sling procedure. Patient demographics, median follow up & complication rates are summarized below in Table 1. In both groups the procedure was done through a perineal approach. There was no significant difference in baseline data among groups. Complication rates between AUS devices and bulbourethral slings showed no statistically significant differences (12.5% vs 6.25% p= 0.22 respectively). Infection rates and need for revision also did not show any statistically significant differences. With regards to post-operative continence rates, both groups had comparable outcome with no significant differences (P = 0.81). Upon the 6 months follow up visit, the AUS group, 56% were pad free, 19% used 1 pad per day, 19% used 2 pads per day, and 6% used 3 pads or more per day, while in the sling group, 50% were pad free, 25% used 1 pad per day, 19% used 2 pads per day, and 6% used 3 pads or more per day. Patients were followed for a total of 1 year after the surgery. Conclusions The combined insertion of IPP with either AUS or sling procedures has comparable outcomes with regards to continence rate and device- related complications. Each incontinence surgery should be chosen according to surgeon experience and specific patient indications. Further prospective studies on a larger sample of patients with longer follow up period are needed to solidify these findings and will guide patient's decision and preference for incontinence surgeries along with IPP once indicated. Disclosure No.

(177) Androgen Deprivation Therapy Does Not Increase Rates for Reintervention, Complication, or Infection in Penile Implant or Artificial Urinary Sphincter Surgery

Abstract Introduction Prostate cancer treatment carries significant quality of life implications, namely erectile dysfunction and stress urinary incontinence. Treatment options include genitourinary implants such as inflatable penile prosthesis (IPP) or artificial urinary sphincter (AUS). Given the association with androgens and penile and urethral health, there may be concern patients on androgen deprivation therapy (ADT) could have worse outcomes following IPP and AUS. Objective To evaluate whether patients on ADT undergoing IPP and AUS surgery are at increased risk for reintervention, complication, and infection. Methods We queried TriNetX, a collaborative research enterprise, for all adult male patients undergoing AUS or IPP. Cohorts were defined by those taking ADT 3 months before or anytime after surgery and those not taking ADT. ADT medications included: leuprolide, bicalutamide, flutamide, nilutamide, apalutamde, and darolide. We performed sub-analysis for leuprolide and bicalutamide, the two most prescribed ADT medications. Cohorts and outcomes were defined using Current Procedural Terminology (CPT) and International Classification of Diseases (ICD-10) codes. We used the impact of age, prostate cancer, history of prostatectomy and history of radiation to generate propensity score matching (PSM). Our primary outcome was need for reintervention (revision, removal, or replacement surgery based on CPT codes). Secondary outcomes included infection rate and complication rate based on ICD-10 codes. Analytics were performed via TriNetX on demographic data which calculated Risk Ratios and were run July 2023. Results There were 12,143 patients who received an IPP and 5487 who received an AUS (Table 1), with. 401 and 635 patients on ADT, respectively. Patients on ADT had similar rates of reintervention (9.4% vs 12.9%, RR = 0.72, p = 0.11), complication (17.7% vs 22.8%, RR =0.78, p=0.08), and infection (4.1% vs 4.8%, RR =0.84, p=0.60) for IPP. For bicalutamide, patients had lower complication rates (11.3% vs 18.2%, RR = 0.62, p=0.04) and similar reintervention rates (5.2% vs 9.9%, RR = 0.52, p=0.07). There were less than 10 instances of infection and thus TriNetX rounded these numbers to 10 (denoted by *) as part of a patient safety mechanism. Rates were similar for patients on leuprolide (reintervention: 9.8% vs 8.9%, RR =1.1, p = 0.69, complication: 17.5% vs 17.8%, RR = 0.98, p=0.92, infection: 4.0% vs 4.9%, RR = 0.81, p=0.57). Patients receiving an AUS showed similar rates for reintervention (20.8% vs 24.0% RR =0.87, p=0.17), complications (26.1% vs 25.6%, RR=1.0, p=0.85), and infections (2.3% vs 3.7%, RR=0.61, p=0.13) regardless of ADT. This held true for subanalyses for bicalutamide (reintervention: 22.7% vs 22.3%, RR =1.0, p = 0.92, complication: 27.7% vs 24.6%, RR = 1.1, p=0.43, infection: 3.8%* vs 3.8%*, RR = 1, p=1)., and leuprolide (reintervention: 19.8% vs 23.3%, RR =0.85, p = 0.18, complication: 25.3% vs 28.7%, RR = 0.8, p=0.21, infection: 1.9%* vs 3.2%, RR = 0.59, p=0.17). Conclusions Patients with IPP or AUS seemingly do no worse on ADT and in some comparisons even seemed to fare better. Further evaluation into the duration of ADT may provide clinical context, but based on these results, ADT should not limit implant surgery. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific, Coloplast.

(222) Simultaneous Inflatable Penile Prosthesis and Adjustable Male Sling: A Step-by-Step Surgical Technique

Abstract Introduction Erectile dysfunction (ED) and urinary incontinence (UI) are common complications following radical prostatectomy (1). At twenty-four months post-surgery, approximately 43% of men experience some degree of ED, while UI affects around 15% of patients between twelve to twenty-four months (2, 3). Notably, nearly 20% of patients experience both ED and UI complications (4). Initial conservative management strategies include the use of PDE-5 inhibitors, intercavernosal injections, or a vacuum erectile device for ED and pelvic floor muscle training for UI (5). However, symptoms that persist or worsen beyond six months can be considered for surgical intervention (6). Surgical options include penile prosthesis implantation for ED and diverse techniques such as the Artificial Urinary Sphincter (AUS) or adjustable male urethral sling, depending on symptom severity, for UI management. Limited evidence suggests that a simultaneous surgical approach addressing both conditions can be a cost-effective and a safe alternative to separate surgeries (7, 8). Objective In this context, the objective of this video presentation is to illustrate a detailed, step-by-step technique for the simultaneous implantation of an inflatable penile prosthesis (IPP) and an adjustable male sling (AMS), while also discussing its feasibility, safety, and functional outcomes. Methods The combined IPP and AMS surgery is a safe, viable, and cost-effective option for patients who need to address both ED and UI. Rhee (2005) initially described the concurrent placement of a penile prosthesis (PP) and male sling (MS) in a series of four post-prostatectomy patients. Results The results demonstrated successful restoration of erections and complete continence in all patients, with no postoperative complications. Our previous systematic review, comparing the outcomes of simultaneous surgical placement of PP and MS versus PP and artificial urethral sphincter (AUS), found no clinically significant differences in outcomes between the two groups (Raheem 2021). Therefore, the simultaneous placement of IPP and AMS should be considered an option for patients, as it shows comparable effectiveness to other concurrent surgical interventions. Dual implantation of PP and male sling have also demonstrated cost savings of approximately $9,000 for patients, further enhancing its advantages in managing both ED and UI (Gorbatiy 2010). Ultimately, a collaborative discussion between patients and their urologist is crucial in determining the most suitable approach for patient individual needs. Conclusions The simultaneous surgical placement of an inflatable penile prosthesis (IPP) and adjustable male sling (AMS) presents a favorable and viable solution for managing erectile dysfunction (ED) and urinary incontinence (UI) in patients who exhibit an inadequate response to conservative management following prostatectomy. Disclosure No.

(046) An Approach to the Thoughtful Selection of Antimicrobial Prophylaxis for Inflatable Penile Prosthesis Surgery

Abstract Introduction There is a growing body of evidence questioning the efficacy of the antibiotic prophylaxis regimens recommended by the American Urological Association (AUA) Best Practice Statement (BPS) for IPP surgery. However, since publication of the BPS the use gentamicin and vancomycin use has increased substantially. This is potentially due to a lack of other specific prophylaxis recommendations making it difficult for surgeons to know which agents to select. Objective We sought to create a simple process to enable surgeons to select an individualized prophylaxis regimen which accounts for local antibiotic resistance patterns. Methods We retrospectively collected IPP infection history from 3 surgeons from 3 different regions of the United States between 2016 and 2021. Local hospital antibiograms were obtained for each surgeons’ institution. Each surgeons IPP infection history was crossed with the resistance patterns on the local antibiograms to identify prophylactic antimicrobial regimens providing the highest level of coverage. Results The organisms causing implant infections for each surgeon during the inclusion period are reported in Table 1. Vancomycin and fluconazole provided excellent Gram-positive and fungal coverage for all surgeons, however Gram-negative coverage varied. Surgeon A had a history of ESBL-producing E. Coli and no infections from Pseudomonas sp. Gentamicin and tobramycin have poor coverage of ESBL-producing E. coli (61% and 52% respectively). However, pipercillin/tazobactam covers 92% of ESBL-producing E. coli. The only Gram-negative organism that pipercillin/tazobactam has worse coverage of than the aminoglycosides is Pseudomonas (gentamicin-92%, tobramycin-96%, pipercilin/tazobactam-80%); however, Surgeon A had no history of Pseudomonas infections. Therefore, the greatest level of coverage can be obtained with vancomycin, pipercillin/tazobactam, and fluconazole. All of Surgeon B’s infections were caused by non-ESBL producing E. coli. Gentamicin, tobramycin, and pipercillin/tazobactam all have excellent coverage of E. coli (95%, 94%, and 95% respectively). Comparing these agents to other common pathogens shows superior coverage of tobramycin over gentamicin and pipercillin/tazobactom for Pseudomonas. The highest level of coverage for Surgeon B can be obtained with vancomycin, tobramycin, and fluconazole. Surgeon C’s infection history has a predominance of Klebsiella sp., but also includes Pseudomonas. Both gentamicin and tobramycin have excellent coverage (>95%) of these Gram-negative organisms. The highest level of coverage can be obtained with vancomycin, an aminoglycoside, and fluconazole. Conclusions The use of local antibiograms and infection history is a simple strategy to tailor prophylaxis regimens to resistance patterns. We found a different regimen to be superior at each institution. Surgeon B’s experience demonstrates that all aminoglycosides may not be equal when factoring in local resistance patterns. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Cynosure, Antares Pharma, Clarus Pharmaceuticals, Acerus Pharma, Boston Scientific.

(045) Comparing Bacterial Presence with the Usage of 0.05% Chlorhexidine Gluconate (CHG) Lavage During Urologic Prosthesis Revision Surgery: Update on Results

Abstract Introduction An Inflatable Penile Prosthesis (IPP) is third line surgical therapy for refractory ED. An IPP uses a fluid-filled reservoir with a pump and valve system to activate inflation and deflation. Although penile implants achieve the highest success rates in ED treatment, the possible presence of bacteria on the device itself or bacteria exposure accumulated during the surgery increases the risk of progression into biofilm or infection. Biofilm complicates the bacteria eradication effort and can ultimately jeopardize the implant. Often, the only way to treat the post-op infection is with implant removal. Currently, many preventative measures, such as different perioperative irrigations, are being studied to reduce the number of penile implant infections. Research has shown that irrigation at the time of both infectious and noninfectious surgery lowers subsequent infection rates. Different solutions like saline, antibiotic, betadine, and hydrogen peroxide solutions have been considered. Recently, orthopedic literature has shown that 0.05% Chlorhexidine Gluconate (CHG) lavage has effectively reduced biofilm in artificial joint procedures. Objective The purpose of this study is to determine the effectiveness of CHG lavage on bacterial presence in IPP implant spaces. We hypothesize that CHG will lower bacterial presence after washing out implant spaces at time of replacement for infections and mechanical failure. Methods We aimed to investigate a series of patients who underwent revision IPP surgery while utilizing FDA-approved CHG lavage for irrigation and compared the bacterial presence before and after CHG washout. Additionally, Next Generation Sequencing (NGS), a DNA sequencing technology, was used to further identify the pathogens involved. Results Between 2021 to 2023, 48 patients underwent IPP revision surgery for either infectious or noninfectious reasons. During the operation, a section of the capsule tissue surrounding the implanted IPP pump was first taken and sent for cultures. NGS studies were also sent out. After the implant removal, all implant spaces were irrigated and washed out with CHG (two 450-mL bottles). A second tissue culture was then obtained post washout. Of the 48 patients, there were 4 positive bacterial cultures before washout and 13 positive NGS results. Results of the post CHG washout cultures were all negative. Conclusions It appears that irrigation with 0.05% Chlorhexidine Gluconate solution is an effective antiseptic that can decrease bacterial presence, and hopefully reduce IPP infections. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Microgen Dx, Irrisept.

(179) Does Climate Impact IPP Infection Risk? Assessment of Temperature and Dew Point on IPP Infections

Abstract Introduction Variations in climate have been associated with greater risk of surgical site infections, urinary tract infections, and changes in the skin microbiome. Although the pathogenic organisms for inflatable penile prosthesis (IPP) infections are commonly skin flora, limited data exists on the impact of climate on IPP infections. Objective We sought to evaluate the impact of climate on the pathogenic organisms of IPP infections in a large international, multicenter cohort. Methods We performed a multi-institutional, retrospective study of patients undergoing IPP surgery. We then evaluated whether the month or season, during which surgery was performed, affected device infections. Additionally, we assessed the effect of temperature, dew point, and humidity on the microorganisms involved in implant infections. Infections were classified as Gram positive, Gram negative, or mixed (including a combination of Gram positive, Gram negative, and/or fungi). A univariate logistic regression analysis was undertaken. Results A total of 5289 patients with a mean age of 62.2 ± 10.8 years received IPP placement. A total of 103 (1.9%) infections were recorded. Overall, 38 (36.9%) infections were caused by Gram positive bacteria. An increase in temperature was associated with a higher risk of infection with Gram positive bacteria (OR: 1.03, 95% CI: 1 to 1.07, p=0.035). Infections were more frequent as temperature increased with 74.7% of infections occurring when mean ambient temperature was greater than 55□F. No statistically significant differences were recorded in terms of season (p=0.19) and month (p=0.29). Conclusions Higher temperature is associated with greater risk of Gram positive infections These findings may help surgeons tailor antibiotic prophylaxis based on local climate especially when temperatures are over 55□F. Our findings should prompt further studies regarding the impact of climate on infection prevention to further improve IPP outcomes. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: consultant Coloplast, Cynosure, Antares Pharma, Clarus Pharmaceuticals, Acerus Pharma, Boston Scientific.

Access to inflatable penile prosthesis surgery as indicated by distances traveled among US men with Medicare.

The significance of geographic barriers to receiving inflatable penile prosthesis (IPP) treatment is uncertain according to the existing medical literature. To describe the travel patterns of men with erectile dysfunction (ED) in the United States who underwent IPP surgery. This retrospective cohort study utilized data from the 100% Medicare Standard Analytical Files. Men aged ≥65 years with an ED diagnosis who underwent IPP surgery between January 2016 and December 2021 were identified from the database. Federal Information Processing Series codes from the National Bureau of Economic Research's County Distance Database were used to determine geographic distances from patients' homes to the facilities at which surgery was performed. Evaluations included the proportions of men who traveled outside their county of residence or state for IPP treatment and the average distances in miles traveled. Among 15 954 men with ED undergoing IPP treatment, 56.4% received care out of their county for IPP, at a mean distance of 125.6miles (range, 3.8-4935.0). Although patients aged ≥80 years were less likely to travel outside their county as compared with men aged 65 to 69 years (48.1% vs 57.1%, P < .001), if they traveled, they were likely to travel farther (mean, 171.8 vs 117.7miles; P < .001). South Dakota had the highest proportion of men traveling outside their county for IPP treatment (91.3%; mean, 514.2miles), while Vermont had the highest proportion traveling outside their home state (73.7%). By unveiling disparities in access, this study will potentially lead to tailored interventions that enhance patient care and health outcomes. Strengths include the uniqueness in (1) evaluating the proportions of patients who travel out of their county of residence or home state for IPP treatment and (2) quantifying the average distances that patients traveled. An additional strength is the large sample size due to the retrospective design and database used. The analysis did not capture all Medicare enrollees; however, it did encompass all traditional Medicare enrollees, representing approximately half of all men in the US aged ≥65years. Limitations include not being generalizable to entire population of the US, as the study examined only Medicare enrollees. In addition, the study period includes the pandemic, which could have affected travel patterns. Furthermore, the coding and accuracy of the data are limitations of using administrative claims data for research. Study findings showed that many men with Medicare and ED traveled from their home geographic location for IPP treatment.

An approach to the thoughtful selection of antimicrobial prophylaxis for inflatable penile prosthesis surgery.

An approach to the thoughtful selection of antimicrobial prophylaxis for inflatable penile prosthesis surgery.

Evaluation of androgen receptor markers in erectile dysfunction.

Steroid hormones, such as testosterone, play a crucial role in modulating the development of male internal and external genitalia as well as secondary sex characteristics by binding to the androgen receptor. Once bound, androgen receptor operates as an inducible transcription factor, interacting with a multitude of co-regulators to initiate various downstream signaling pathways. The androgen saturation hypothesis posits that beyond a specific threshold, androgen receptor binding and functionality remain unaltered despite an increase in serum testosterone levels. The objective of this study was to explore the expression of these proteins in penile tissue samples from men with severe erectile dysfunction to enhance our understanding of the influence of serum testosterone on androgen receptor function. Patients undergoing surgical management for high-grade ED at our institution were invited to participate in the study. During inflatable penile prosthesis surgery, corpus cavernosum biopsy was obtained. Protein was extracted from each sample for western blot analysis which was probed with androgen receptor, heme oxygenase, inducible nitric oxide synthase, and phosphodiesterase type 5 antibodies with GAPDH for protein normalization. 12 men agreed to participate in this study. Serum testosterone levels were obtained from all participants on the morning of their surgery. The median testosterone level was 300.15 ng/dL. Our findings revealed a decrease in androgen receptor and inducible nitric oxide synthase expression at serum testosterone levels below 300 ng/dL (p = 0.022, 0.03). Similarly, hemeoxygenase and phosphodiesterase type 5 expression levels were significantly lower at serum T concentrations below 200 ng/dL (p = 0.017, 0.014). These data showed a significant decrease in the expression of proteins downstream of the androgen receptor at lower serum T levels. This suggests a potential correlation between serum T concentration and androgen receptor signaling and supports a potential saturation value between 200 and 300 ng/dL.

Subcoronal Incision for Inflatable Penile Prosthesis Does Not Risk Glans Necrosis.

Glans vascular compromise had previously been considered a rare but devastating complication of the subcoronal incision for inflatable penile prosthesis surgery. Here, we describe the largest series of subcoronal implants to date to assess contemporary complication rates. A retrospective review of subcoronal prosthesis placements by a single surgeon from Seoul, South Korea, was performed. Patients were randomly assigned either Coloplast Titan or AMS 700 device per institutional practice. A total of 898 patients who underwent subcoronal implants from May 2015 to March 2022 were analyzed. Median follow-up was 41 months (IQR 40). Preoperative patient comorbidities included diabetes (36.6%) and Peyronie's disease (4%). The most common complication was transient distal penile edema (74.7%). Transient incisional paresthesia (20.6%) was more common in patients with diabetes (31.9% vs 13.9%, P < .01). Five cases (0.5%) of distal penile skin necrosis were reported in patients who had previously been circumcised. Of these, 3 were managed successfully with wet-to-dry dressing, 1 required skin grafting, and 1 required device explant. Device infection without incisional compromise occurred in 2 cases (0.2%). There were no instances of glans necrosis or ischemia observed in this cohort. Of the first-time implants (817, 90.9%), most (62.3%) were successfully completed under local anesthetic alone, with the remainder of surgeries completed with the addition of adjunctive conscious sedation. Subcoronal incision for first-time or revision penile implant surgery is not a risk factor for glans ischemia or necrosis and can be safely completed under local anesthetic with or without conscious sedation.

(106) Concept of Enhanced Recovery Implant Care (ERIC) in Inflatable Penile Prosthesis Surgery: A Double-blind, Randomized, Controlled Trial on Clinical Outcomes and Patient Satisfaction Rate

Abstract Introduction ERAS (Enhanced Recovery After Surgery) is considered a standard of care intended to achieve earlier recovery and reduce stress response following surgery. While inflatable penile prosthesis (IPP) surgery is a safe and effective treatment for males with erectile dysfunction, complications such as significant postoperative pain and scrotal hematoma are not uncommon and can result in delayed IPP cycling and lower patient satisfaction rate Objective To evaluate the concept of ERIC (Enhanced Recovery Implant Care) on clinical outcomes and patient satisfaction rate following IPP surgery. Methods This prospective double-blind, randomised, controlled clinical trial received internal ethics approval and 60 males were randomised to receive “normal care” (NC) vs ERIC pathway which consisted of a strict perioperative regime of intra-operative regional nerve block and device analgesia elution, meticulous haemostatic corporotomy closure and multi-layered scrotal closure as well as postoperative 7 days of fitted scrotal support following IPP surgery. An independent third-party survey with objective measurement of pain score (visual analogue scale, VAS), analgesic requirement (conversion to opioid dose equivalence), time to IPP cycling and overall patient satisfaction rates (on a 5-point scale) were collected and compared on Day 1, 7, 14, 28 and 42 postoperatively. Results There was no significant difference in patient demographics between the 2 groups. No intraoperative complication was documented. Males in the ERIC group reported lower VAS scores (p&amp;lt;0.05), less analgesic requirement (p&amp;lt;0.05) and shorter time to IPP cycling (p=0.08). Twelve (40%) patients in NC had a scrotal hematoma (Clavien-Dindo grade 1) compared to 2 (7%) patients in the ERIC group on days 1 and 7 postoperative. The overall patient satisfaction rate (rated 4 or 5) was higher in the ERIC compared to NC groups (93% vs. 70%; p&amp;lt;0.05). Conclusions The ERIC pathway appears to improve clinical outcomes and postoperative recovery following IPP surgery in terms of pain score, the analgesic requirement, and time to IPP cycling, as well as the overall patient satisfaction rate. Disclosure No

(431) Frailty Does Not Predict Postoperative Complications Following Inflatable Penile Prosthesis Surgery

Abstract Introduction Frailty, an approximation of a patient’s reserve resulting from age-associated decline across multi-organ systems, has been shown to be an independent predictor of adverse outcomes. Amongst penile prosthesis surgery however, frailty is an underutilized risk factor with conflicting data regarding its impact on surgical outcomes. Objective To evaluate the association between the modified Frailty Index (mFI) and adverse outcomes following inflatable penile prosthesis (IPP) surgery. Methods A retrospective chart review of men who underwent IPP surgery between 1/1/13 and 7/31/20 at a single-institution was conducted. Patient frailty was defined using the mFI, a previously validated measure, which consists of 11 patient characteristics. Each variable is allotted 1 point with aggregate scores ranging from 0 (no frailty) to 11 (highest degree of frailty). Complications were defined as mechanical failure, erosion, infection, hematoma, intractable pain, or other (ex. herniated reservoir, pump revision). Logistic regression was used to determine the association between mFI and complications after controlling for predetermined covariates. Results The final cohort consisted of 337 IPP patients with a median age of 64.6 years (IQR 58.5-68.4) and a median time from surgery to data collection of 66.6 months (IQR 39.0-85.4). The overall complication rate was 9.8% (n=33) with 63.6% of those (n=21) requiring a surgical intervention (ex. explant, remove/replace, revision). The median mFI for patients with a complication was 2 (IQR 1-3) while the median mFI for those without a complication was 1 (IQR 1-2) (Table 1). When adjusting for confounding variables on multivariable analysis, mFI was not associated with either overall (p=0.20) or operative complications (p=0.69) (Table 2). Conclusions While specific frailty metrics such as handgrip strength have been shown to be associated with complications following IPP placement, our results suggest that overall mFI was not associated with adverse outcomes following IPP surgery. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific.