Helo, S

Abstract Introduction The optimal irrigation solution with inflatable penile prosthesis (IPP) remains controversial. Objective We sought to determine the impact of the type of fluid used for dipping and irrigation (D&I) on the risk of IPP infections. Methods This is a retrospective, consecutive cohort study that includes individuals who underwent initial Coloplast IPP insertion or revision between January 2021 and May 2024. Cases done from January 2021 to August 2022 (20 months) underwent Rifampin/Gentamycin for dipping and Vancomycin/Gentamycin for irrigation (Group 1), whereas those from October 2022 to May 2024 (20 months) utilized 0.05% chlorhexidine gluconate for both D & I (Group 2). Surgeon, operative time, age, diabetes mellitus (DM), perioperative level of HbA1C, history of acute urinary retention (AUR), positive urine culture, and oral antibiotic (AB) regimen at discharge were obtained. The rate of infection between the two study groups and the association of risk factors with developing infection were explored by t-test and chi-square analysis for continuous and discrete variables, respectively. P-value less than 0.05 was considered statistically significant. Results In comparison of two study groups, infection rate was significantly higher in group 2 at 2.5% (8/314) than group 1 which did not have any infection (0/280) (P = 0.008). There was no significant association between the study group and operative time (P = 0.45), DM (P = 0.29), HbA1C level (P = 0.20) and AUR (P = 0.87) or surgeon (Table 1). Notably, two clinical infections were from non-virulent organisms (Streptococcus Constellatus & Staphylococcus Lugdunensis). Two of three patients undergoing malleable salvage failed. Since no infection was observed in group1, infection risk predictors were only analyzed in group 2. The patients in group 2 were stratified based on their diabetes mellitus (DM) status, and analyses were conducted to investigate the effect of a positive DM history on the risk of infection. The results indicated that having DM significantly increased the risk of infection, with 75% (6/8) of patients with DM developing an infection compared to 26% (78/306) of those without DM (P = 0.006) (Table 2). Notably, three of eight infections occurred in patients discharged on Augmentin or cefdinir secondary to drug interaction warning (our typical post op prophylaxis is Bactrim or ciprofloxacin). Conclusions Type of antiseptic fluid for D&I and DM were associated with IPP infection following surgery in our patient cohort. Disclosure No.

Abstract Introduction Since FDA approval of Collagenase Clostridium Histolyticum (CCH) for the treatment of Peyronie’s Disease (PD), there has been significant debate as to its role and comparable efficacy in relation to surgical therapies. We therefore sought to compare key outcomes between the two therapies. Objective To compare the satisfaction and adverse event profiles between surgery and CCH injections for the treatment of PD. Methods A randomized, controlled trial is ongoing. Participants were randomized 1:1 to receive either CCH + traction (RestoreX) + sildenafil (CCH) or penile surgery (plication and/or incision and grafting) + traction + sildenafil for PD (Surgery). Objective, standardized, and non-standardized assessments were obtained at baseline and 3, 6, 12, 24, 36, 48, and 60 months post-treatment. Key outcomes included differences in standardized questionnaires, penile curvature, penile length, subsequent interventions, and non-standardized questionnaire responses. Results A total of 40 men were randomized with 24-month data available in 29. Mean age was 54.7 years, PD duration 37.4 months (mo), composite curvature 73.1 degrees (deg), and penile length 12.7 cm. All baseline variables were similar between cohorts. Regarding primary outcomes, at 24-months post-treatment, CCH men were more likely to report being very satisfied with treatment (62% vs 25%, p < 0.05). For secondary outcomes, only questionnaire data were captured at two years without objective measurements obtained. No differences were noted between groups regarding subscales of the IIEF, PDQ, Beck’s Depression Inventory, or SEP-2, however CCH men had better SEP-3 positive responses (62% vs 19%, p = 0.02), indicating improved ability to maintain erections sufficient for intercourse. Surgery men reported higher subjective rates of length loss compared to CCH (81% vs 15%, p < 0.001) and curvature recurrence (56% vs 8%, p < 0.01), but similar rates with changes in sensation, indentation/hourglass, and erectile function. Both groups indicated similar willingness to undergo the therapy again. Interestingly, at 2-years, the majority of men in the Surgery arm said that their initial preference for treatment was surgery (56%), which decreased from a peak 86% at 1-year. However, in reviewing baseline information, 72% of Surgery men actually preferred CCH at study onset, highlighting a significant recall bias towards whatever treatment one actually ended up receiving. Conclusions Preliminary data suggests that when compared to surgery at 24-months, CCH men were more likely to be very satisfied with therapy, have greater subjective length improvements and lower curvature recurrence rates. Disclosure Yes, this is sponsored by industry/sponsor: Endo Pharmaceuticals. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: PathRight Medical.

Abstract Introduction Age is often correlated with various medical conditions, including bother with the condition itself. Peyronie’s disease (PD) is a condition which is most often associated with men in their 50-60’s, however, it does affect younger men as well. Anecdotally, younger men with PD appear to be more bothered by their condition compared to older men. We therefore sought to evaluate whether there is a difference among older vs younger men as to the degree of bother linked to PD. Objective To evaluate age as a potential predictor of bother associated with PD. Methods A prospective database has been maintained of men seeking treatment for PD. Beginning in Feb 2020, we began implementing men routinely completed standardized intake questionnaires relating to PD, including the Peyronie’s Disease Questionnaire (PDQ). The PDQ consists of 15 questions broken down into three key subdomains: psychological and physical, penile pain, and symptom bother. Men who had completed the PDQ questionnaire were evaluated to determine the correlation between various clinicopathologic variables and the PDQ-bother domain. Results A total of 645 men were seen for symptoms of PD and had PDQ questionnaire data available for review. Baseline demographics included a mean age was 51.8 years (SD 17.6), mean PD symptom duration 31.3 months (SD 65.3), estimated curve of 40.9 degrees (SD 26.8), and mean PDQ-Bother score 8.9 (SD 3.1 – Note: lower is better). Several clinicopathology variables were found to be associated with increased PDQ-bother scores, including age (younger = less bothered, parameter estimate -.0.03, p=0.03), the presence of indentation or hourglass (yes 9.4, no 8.4, p<0.05), pain (yes 9.3, no 8.5, p=0.16), PD preventing penetrative intercourse (yes 9.5, no 8.7, p=0.07), penile shortening (yes 9.3, no 8.7, p=0.10), subjective erectile dysfunction (yes 9.6, no 8.5, p<0.01), and subjective premature ejaculation (yes 9.8, no 8.4, p<0.01). Interestingly, several variables did not correlate, including the duration of relationship, frequency of intercourse, duration of symptoms, direction of curve, degree of curvature, partner pain with intercourse, or libido. Conclusions Several notable factors are associated with PD bother (as assessed by the PDQ-bother domain), and equally importantly, several factors are surprisingly not associated (e.g. curvature degree and direction). These factors provide useful information to the practicing clinician to help better identify men who may be at greater risk for bother associated with the condition. Disclosure No

ABSTRACT Introduction Vasectomy reversal (VR) is rarely covered by insurance, creating a market similar to cosmetic surgery with direct marketing to patients. While cost is an immediate concern for patients, surgeon training and experience are essential for a successful outcome. Patients considering VR are likely to seek information online regarding providers and the nature of the procedure. Objective In this study, we reviewed the characteristics of providers marketing VR online, as well as the comprehensiveness of their website content. Additionally, we sought to determine differences in VR practice patterns between academic and private practices. Methods We identified VR practices operating within the top 50 populous metropolitan areas in the USA. Practice websites were reviewed to obtain information such as educational background of providers, use of operating microscope, ability to perform vasoepididymostomy (VE), surgical volume, and out-of-pocket cost. Based on the information available from practice websites, providers were assigned a non-validated “REVERSAL score” out of 12, based on 8 domains (Risks disclosure; provider's Educational background; ability to perform VE; Expense disclosure; success Rate disclosure; Surgical volume disclosure; disclosure of Alternatives to VR; and Level of magnification used for VR) (Table). Descriptive statistics were used to compare the results between academic and private practices. Results 107 providers were identified (29 academic and 78 private). All but 2 were male, and similarly all but 2 had Doctor of Medicine (M.D.) degree. Review of practice websites allowed us to obtain complete information (REVERSAL score of 12) on only one provider (academic), with the majority (66%) of providers achieving REVERSAL score of ≤6. Providers with formal fellowship training in andrology, microsurgery, and/or infertility achieved higher REVERSAL scores compared to those without (6.9 ± 2.4 vs. 4.8 ± 2.4, p < 0.01). Academic providers were more likely to have completed pertinent fellowship training compared to private practice providers (97% vs. 44%, p < 0.05). Only 14% of academic providers disclosed procedure cost online, compared to 40% of private practice providers (p < 0.05). There was a trend toward increased use of online advertisements by private practice providers (22% vs. 10%, p = 0.07), and increased reference to literature success rates by academic providers (59% vs. 41%, p = 0.10). Among the 35 providers who disclosed pricing online, mean cost of VR was $5,990 ± 1,935. There was a non-significant trend toward increased cost with academic practices compared to private practices ($7,337 ± 1,103 vs. $5,765 ± 1,964, p = 0.09). There was significant reduction in cost when comparing non-urologists vs. urologists ($3,584 ± 1,554 vs. $6,591 ± 1,518, p < 0.01), and when comparing providers without pertinent fellowship training to those with ($5,405 ± 2,000 vs. $6,769 ± 1,590, p < 0.05). Conclusions There is significant lack of transparency in publicly available information from VR practices, both academic and private. Practices should implement measures to improve the dissemination of information to the general public, so that patients may more easily compare various providers. Disclosure Work supported by industry: no. A consultant, employee (part time or full time) or shareholder is among the authors (Coloplast, AMS).

ABSTRACT Background Penile length loss and erectile dysfunction (ED) are common post-prostatectomy. Recent results from a randomized, controlled study (RCT) of RestoreX penile traction therapy (RxPTT) demonstrated preserved erectile function and penile length improvements in men post-prostatectomy. Objective To report outcomes of the open label phase (6-9 month time point) of the previously noted RCT comparing efficacy of RxPTT to control in men post-prostatectomy. Methods A randomized, controlled trial (NCT03500419) has been completed of 82 men post-prostatectomy. Men were randomized 1-month post-prostatectomy to no therapy (control, n=27) or RxPTT (n=55) for 5 months. Participants then entered an open label phase for 3 months. Assessments included stretched penile length (corona), standardized (International Index of Erectile Function [IIEF]), and non-standardized questionnaires. Comparisons were performed of men who utilized traction at least 15 minutes daily for both phases to men who were originally control and continued with no treatment (as-treated analysis). Analyses were also performed of men who crossed over from control to >15 min daily (crossover to treatment) and those who were originally in the treatment group and continued with >15 min daily use during the open label phase (ongoing treatment). Results Of the 82 men enrolled (mean age 58.6), 55 had 6-month, and 42 had 9-month data available to review. Baseline characteristics (IIEF scores, penile length) were similar between cohorts. In the as-treated analysis (no treatment n=7, RxPTT x 8 months n=12, respectively), differences were as noted: IIEF-EFD (-8 vs -0.5, p=0.19), IIEF-OFD (-3 vs -2, p=0.86), IIEF-SD (-1 vs 0.5, p=0.09), IIEF-ISD (-3 vs -0.5, p=0.31), IIEF-OSD (-2 vs 0, p=0.29), penile length (-0.1 vs +1.8 cm, p<0.01), PDE5 use (86% vs 75%, p=0.57), intracavernosal injection use (86% vs 17%, p<0.01). Comparing men who did not use therapy at any time (n=7) to those who crossed over to RxPTT during the open label phase (n=8) demonstrated the following results: IIEF-EFD (-8 vs -6, p=0.49), IIEF-OFD (-3 vs -1, p=0.90), IIEF-SD (-1 vs 0, p=0.55), IIEF-ISD (-3 vs -1, p=0.45), IIEF-OSD (-2 vs -1, p=0.51), penile length (-0.1 vs +0.69 cm, p=0.39). Men who crossed over from RxPTT to no treatment (n=10) had relatively preserved improvements compared to those who continued with RxPTT during the open label phase (n=12) compared to baseline, respectively: IIEF-EFD (0 vs -0.5, p=0.95), IIEF-OFD (-3.5 vs -2, p=0.97), IIEF-SD (0 vs 0.5, p=0.18), IIEF-ISD (0 vs -0.5, p=0.87), IIEF-OSD (0 vs 0, p=0.66), penile length (+1.8 vs +1.8, p=0.99). Conclusions Although sample size and statistical power are limited, results from the open label phase confirm earlier findings of preserved sexual function and penile length in men treated with RxPTT compared to controls. Men who crossed over from controls to treatment experience benefits, although not as significant as those who were treated beginning at 1 month post-prostatectomy. Men who stopped therapy after 6 months demonstrated stable improvements from baseline, suggesting a preserved effect of RxPTT even after discontinuing use. If validated with external series, these findings would represent a significant advancement in the prevention of sexual dysfunction post-prostatectomy. Disclosure Work supported by industry: no.

ABSTRACT Introduction The significant overlap of risk factors for erectile dysfunction and venous thromboembolism (VTE) may disproportionally increase the risk of VTE in men undergoing inflatable penile prosthesis (IPP) surgery. Owing to the absence of available literature, AUA and EAU perioperative VTE guidelines do not address VTE risk with IPP surgery and generally recommend against pharmacologic prophylaxis with outpatient surgery. The Caprini Score is a validated scoring system to estimate VTE risk in the perioperative period. Objective We sought to assess the risk of VTE by calculating Caprini Scores in men undergoing IPP surgery. Methods We retrospectively reviewed and calculated Caprini Scores for patients undergoing IPP surgery at our institution between July 2017 and June 2019. Results 215 patients undergoing IPP surgery were identified with a mean and median Caprini score of 5.96 (SD, 1.63) and 6 (IQR 5,7), respectively. 84% of the cohort was classified as high or highest risk for VTE (Figure 1). This is in part due to our cohort's mean age of 64, mean BMI of 31 and history of prostate cancer treatment as the cause of ED. Prior history of VTE (deep vein thrombosis(DVT) or pulmonary embolism (PE)was identified in 17 (8%) patients with 5 (2%) have a history of both DVT and PE. Conclusions Men undergoing IPP surgery are high risk for VTE based on Caprini score assessment. VTE prophylaxis should be considered in men undergoing penile implant surgery. Before widespread application, long-term data is necessary to assess safety and efficacy of VTE prophylaxis in the IPP surgery population. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Senior author consultant for Coloplast

ABSTRACT Introduction Chronic pelvic and/or genital pain is a disabling condition and commonly associated with poor quality of life, impaired sexual function and decreased productivity. Objective To examine treatment outcomes among a cohort of patients diagnosed with refractory pelvic and/or genital pain enrolled in a 3-week interdisciplinary pain rehabilitation program (IPRP). Methods A series of with-in subjects ANOVAs (corrected for multiple comparisons) were used to evaluate the effectiveness of IPRP on self-report (pain severity, interference, depressive symptoms, quality of life) and observer-rated outcome (5 minute walk) among 15 treated patients receiving care at the Mayo Clinic IPRP between 2016-2018. Results Fifteen patients (5 male, 10 female) were identified. Mean age was 47.0 (range: 24-78) and primary diagnoses were pelvic pain (n=13) and penile pain (n=2). Significant within-subject effects were detected for all self-report outcomes and the 5-minute walk test (see table 1). Six patients were on opioid therapy (MME = 49mg), and all but one successfully tapered off opioids. In the remaining patient, daily MME decreased from 150 mg to 30 mg. Conclusions Intensive outpatient IPRP significantly improves quality of life for patients with treatment-refractory chronic pelvic and/or genital pain. These results support multi-disciplinary treatment paradigms for refractory urogenital pain. Disclosure No

ABSTRACT Introduction IPP revision after implant malfunction yields rare insight into patient preference and perception of penile implant variations in brand and size. Objective To assess patients’ perception of their penile implant after IPP revision. Methods Retrospective review of all patients undergoing revision surgery for purely mechanical malfunction (fluid leak) at our institution since 2017. Patients with greater than 6 months follow-up after revision were contacted to comment on changes in penile size and device preference. Patients were asked 1. “Did you notice any change in penile length or girth after your last surgery, explain, and 2. “Please describe your preference (if any) of implant and why”. We utilize the Coloplast Titan with “classic” (genesis) pump in most cases, with AMS Cx cylinders being used in cases with attenuated corpora (aneurysm). Results 21 patients were identified that met criteria with an average age of 70. 15/21 were successfully contacted. 9 Coloplast, 2 Mentor, and 12 AMS devices (Cx =7, LGX =4, Ultrex =1) were revised. Device brand used to replace the broken IPP was n= 19 for Coloplast and n=3 for AMS (Cx =2, Lgx =1). Mean and median time to revision was 9 years overall (2-26) and was similar between Coloplast and AMS. Fluid leak location showed no discernable pattern. Total average implant length increased 2.2 cm from 20.6 cm to 22.8 cm. 8/10 patients were reached that had had both AMS and Coloplast devices (all AMS initially). 12 patients stayed within the manufacturer. Despite change in implanted length, most patients did not discern a definitive change in penile length unless cylinders increased by > 3 cm (perhaps reflecting under-sizing of initial implant). All patients correctly described improvement or no change in penile girth when compared to actual cylinder sizes. Patients preferred Coloplast (6 – girth/erection quality/pump), AMS (1 pump/flaccidity) and undecided (1). Several patients felt consistently cycling the device after revision led to relative length improvement and ease of use. Conclusions Our small cohort of IPP revision patients for mechanical failure reveals that revision often requires longer cylinders but this is often imperceptible to the patient. Increased cylinder girth was a key factor in driving device preference. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Senior author consultant for Coloplast

ABSTRACT Introduction Patient satisfaction after inflatable penile prosthesis (IPP) placement has been linked to preexisting curvature. Intraoperative findings such as curvature on artificial erection (AE) or asymmetric corporal measurements (ACM) are incompletely characterized in terms of impact on IPP outcome. Objective We sought to evaluate the clinical utility of AE and the significance of ACM during IPP surgery. Methods A single institution retrospective review of patients undergoing primary IPP placement between 7/2019-9/2020 was performed. Patient characteristics and intraoperative measurements were compared. Threshold for statistical significance was p≤0.05. Results A total of 130 patients underwent primary placement of penile prosthesis. Median age was 67 years (IQR 13). Comorbidities included prostatectomy in 33.8%, and known Peyronie's disease in 21.5%. Of the 27.7% (n=36) of patients who underwent intraoperative AE, 63.9% (n=23) had visible curvature. Of the patients with visible curvature, 70% (n=16) had a preoperative diagnosis of Peyronie's disease and 56.3% (n=9) underwent straightening procedures compared to 28.6% (n=2) of the 30% (n=7) with no known curvature. Incision and grafting was most frequently performed (6/11)- with a minority undergoing plication (2/11). Of the 72.3% (n=94) who did not undergo AE, only 2.1% (n=2) required additional measures for curvature correction. Median corporal measurement was 21 (IQR 2) bilaterally and median cylinder size 20 cm (IQR 4) bilaterally with 1cm rear tip extenders. Of the 18.5% (24/130) of patients with ACM, asymmetry was as follows: 20.8% (5/24) had less than 1 cm, 70.8% (17/24) had 1 to <2 cm, and 8.3% (2/24) had 2 cm or greater. Of these patients 87.5% (21/24) underwent placement of an asymmetric device, only 5% (1/21) of which had residual curvature less than 30 degrees. Despite ACMs, 12.5% (3/24) of patients had a symmetric device placed, one of which had residual curvature. Only 2 patients underwent straightening procedures including plication and incision/grafting. Conclusions Intraoperative AE is effective at revealing occult penile curvature at time of IPP placement, however most men with newly detected curvature do not require additional straightening measures. We also found that 1 in 5 patients undergoing IPP had ACM but this did not correspond to residual curvature following IPP or requirement for adjunct straightening. These findings may provide reassurance to urologists who do not routinely perform AE or those who encounter ACM during corporal dilation Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific, Coloplast

ABSTRACT Introduction Erectile dysfunction (ED) stems from a variety of etiologies and often requires a multidisciplinary approach to optimize patient care. Objective We sought to assess attitudes and confidence regarding the treatment of erectile dysfunction across different provider types. Methods Anonymous, email-based survey of physicians and advanced practice providers in the disciplines of urology, internal medicine, and family medicine. Responses were recorded using a five-point Likert scale. Descriptive statistical analysis of survey response data was performed. Results With 76 providers on this ongoing survey including 31 internists, 24 family physicians, and 21 urologists, 88% of providers believed there to be good options for erectile dysfunction after failing pills. Figure 1 shows attitudes of the modalities of “good” options and confidence in the ability to counsel about these options. Regarding if most patients report willingness to consider surgical intervention for ED when counseled about it an equal portion of providers had positive, neutral, and negative feedback. Figure 2 lists other specific attitudes and opinions about penile prosthesis (IPP) implants. Moreover, 78% emphasized the necessity of a multidisciplinary team-based approach to ED patients. However, only 30% of the participants were in agreement with referrals to specialists in sexual health including urologists. Conclusions This survey indicates a knowledge gap and low comfort level in 2nd and 3rd line ED treatments. Focused education on penile implant outcomes appears particularly helpful. Disclosure No