Abstract Introduction Discrimination and sexual harassment within the workplace have a negative impact on well-being and productivity and are often underreported due to lack of comfortability in confronting the offender. Objective We aim to assess the prevalence of these abusive behaviors within a urology department and the impact of a dedicated training session on comfortability reporting/confronting discrimination and harassment. Methods Employees within a urology department at a single institution were invited to take a survey regarding discrimination and harassment both before and after a dedicated training session on reporting and confronting these behaviors. Statistical analyses were performed between pre- and post-survey groups, genders, and roles within the department. Results A total of 77 participants were included, 52 (67.5%) identified as female. Roles within the department included physician (25; 32.5%), advanced practice provider (11; 14.3%), nurse (20; 26%), and nonclinical staff (21, 27.2%). More women reported experiencing sexual harassment at least once a year compared to men (38.6% vs. 16.7%, p < 0.001). Patients were the most commonly reported offenders of abusive behaviors towards staff (p < 0.05) Fig. 1.A. The training demonstrated a positive impact in respondent comfort level with addressing gender discrimination (14.3% increase in comfort; p = 0.043) Fig. 1.B. Conclusions Specific training on strategies for addressing abusive behaviors can help employees feel empowered to confront gender discrimination by both patients and their peers. Disclosure No.
(228) PARTNER SATISFACTION AFTER PENILE PROSTHESIS PLACEMENT IN PATIENTS WITH ERECTILE DYSFUNCTION
Abstract Introduction Penile prosthesis (PP) implantation is associated with high patient satisfaction and improved sexual quality of life in medically refractory erectile dysfunction (ED). Despite the current surgical advances and patients’ satisfactions after PP implantation, there has been paucity of data on reported partner satisfaction. We aimed to evaluate changes in partner satisfaction after PP placement. Objective We aimed to evaluate changes in partner satisfaction after PP placement. Methods We initiated a registry of patients undergoing surgery for placement of a PP. After consent, Perioperative study assessments and follow-ups were conducted. After surgery, patients were directed to fulfill a survey at 6 months and 12 months. Patients who fulfilled both items were included in the analysis. Results A total of 304 patients had a PP placement, of these 101 completed the survey. At 6 months, 62 patients (61.4%) reported a moderate to high partner’ satisfaction, and this positive response was sustained at 12-months (82.3%). 73.3% of partner’s reported no-pain after 6 months and this increased to 79.7% after 12 months. 67.3% of partners stated they would recommend the procedure to a friend or family at 6-months. This increased significantly to 84.8% at 12-months (p = 0.012). Conclusions Penile prosthesis placement is associated with high partner satisfaction rates, with a sustained positive perception over time when comparing 6 and 12-month follow-up outcomes. Further study is warranted to assess partner satisfaction after penile prosthesis implantation. Disclosure Yes, this is sponsored by industry/sponsor: COLOPLAST. Clarification: Industry funding only - investigator initiated and executed study.
(208) SOCIAL MEDIA, BODY DYSMORPHIA AND RESISTANCE TRAINING: THE EMERGING WAVE OF ANABOLIC ANDROGENIC STEROIDS IN MEN
Abstract Introduction Resistance training by recreational sportspeople in fitness settings has become increasingly popular worldwide, moreover an increasing landscape of social media (SM) influencers in bodybuilding have arisen since 2021, specially on short-duration videos (clips). Some Image enhancer drug users, including anabolic androgenic steroids (AAS) are known to mistrust medical health professionals and seek out information and advice from online sources. Objective we aimed to quantitatively assess the quality of social media videos as an information source for AAS usage in the general population. Methods A search was performed on the most popular short-clips social media platforms in the US (TikTok, YouTube) with the most searched terms for AAS. The first 50 results with any search term listed by relevance were selected in each platform. Video features (views, likes, subscribers) and video sources were collected. Each video included in the study was assessed using DISCERN score to quantify the source quality. Results A total of 100 videos were included and analyzed. Most videos (84%) were from non-health professionals (influencers/clip source/podcasts), only 7% of the videos came from a health educator/physician. Most videos were rated as “very poor” (85%) and “poor” (7%) According to the DISCERN classification, there was a statistically significant difference (p < 0.001) by both content creator type, and platform with the highest scores among physicians [37 (33-41)] and YouTube [19(17.7-30.2]. [Fig]. Conclusions Image-centric social media use is positively associated with the use of AAS. Despite the increasing number of information, the overall quality was poor. The misleading, inaccurate and incomplete information may pose a health risk to the viewers. Further efforts in health policies are strongly encouraged to assess this problem. Disclosure No.
(202) CERAMIDE TEST IN PATIENTS WITH ERECTILE DISFUNCTION TO ASSESS CARDIOVASCULAR RISK
Abstract Introduction Erectile dysfunction (ED) is a known precursor and sequelae to diagnosed cardiovascular disease (CVD). ED severity predicts CVD severity. AUA guidelines recommend evaluating serum lipids and using an ED diagnosis as an opportunity to discuss and address cardiovascular risk. Serum plasma ceramides are novel predictors of adverse cardiovascular events independent of traditional risk factors such as LDL and hsCRP levels. Ceramide levels improve with lifestyle modification. Objective We aimed to evaluate the utility of ceramide levels in ED patients utilizing self-reported erectile function results (IIEF-6). Methods We initiated ceramide testing in all patients with ED and Peyronie’s disease in late 2019 (in addition to lipids, Hgba1c, etc). We retrospectively analyzed ceramide levels from electronic records with IIEF-6 results. For the statistical analysis we dichotomized our cohort by ED symptom severity (moderate/severe ED: IIEF ≤17 vs. no/mild ED: IIEF ≥18) and ceramide levels by CV risk strata (moderate or higher >6). A Fisher exact test was performed. Results A total of 354 patients were reviewed, of these 253 (71.4%) had moderate ED or higher. A statistically significant difference in abnormal ceramide values was found in patients with mild to moderate symptoms severity or higher, and the odds of getting an abnormal ceramide test was increased based on the IIEF scoring alone (OR 2.3 [1.04– 5.12]; p value = 0.034) [Figure]. Conclusions Patients undergoing management for erectile dysfunction may benefit from serum ceramide testing and subsequent cardiac referral. In our cohort, men with moderate to severe ED were twice as likely to have actionable ceramide levels. Further study is warranted to optimize utility of ceramide in men with ED and potentially drive lifestyle change. Disclosure No.
(165) NOVEL INSIGHTS ON PERIOPERATIVE ANTIMICROBIAL PROPHYLAXIS PATTERNS FOR INFLATABLE PENILE PROSTHESIS: FINDINGS FROM A LARGE MULTINATIONAL COLLABORATIVE
Abstract Introduction Inflatable penile prosthesis (IPP) surgery is a well-established treatment for erectile dysfunction (ED). There is little information in the literature regarding the utilization of perioperative antimicrobial prophylaxis in primary and revision IPP surgeries. Objective We investigated the patterns of perioperative antimicrobial prophylaxis among a large multinational cohort of primary and revision IPP surgeries. Methods We conducted a retrospective analysis of 5,400 patients (4,187 primary IPP patients and 849 revision IPP patients) from our Prosthetic Urology Multi-Institutional Partnership (PUMP) institutions. Usage data for intravenous (IV), preoperative oral, and postoperative oral antimicrobials were analyzed. We specifically assessed patient profiles, antimicrobial selection, and antimicrobial duration. Multivariate statistical analyses were conducted to identify significant variations between primary and revision surgeries. Results For patients undergoing primary IPP placement, 81.9% received IV antibiotics for <24 hours whereas 18.1% received IV antibiotics for >24 hours. Preoperative oral antimicrobials were used in 59.4% of patients and 99.4% received postoperative oral antimicrobials. The overall infection rate for primary implants was 2%. Notably, quinolone administration shows a higher postoperative infection rate (11.4%) compared to gentamicin (1.9%), cephalosporin (0%), and vancomycin (1.0%). Multivariable regression analysis identifies factors such as a history of infection, diabetes, and priapism as predictors for postoperative infections. Furthermore, the study finds that perioperative antifungal use is associated with a decreased risk of infection. Conclusions This study provides valuable insights into the patterns of perioperative antimicrobial prophylaxis. Duration, type, and route of antibiotics given preoperatively or postoperatively do not affect postoperative infection rates among high volume prosthetic urologists. Giving IV antibiotics for more than 24 hours does not affect postoperative infection. Perioperative antifungals are a protective factor. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Clarus Therapeutics, Antares Pharma, Acerus.
(164) AN UPTICK IN IPP INFECTIONS WITH 0.05% CHLORHEXIDINE GLUCONATE
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.
(136) A NONINTERVENTIONAL, RETROSPECTIVE MULTICENTER STUDY TO EVALUATE CCH TREATMENT IN ADULT MALE PARTICIPANTS WITH VENTRAL CURVATURE OF THE PENIS DUE TO PEYRONIE’S DISEASE
Abstract Introduction Peyronie’s disease (PD) is a connective tissue disorder characterized by the replacement of normal elastic fibers of the tunica albuginea with collagen-containing plaques. This alteration may result in penile deformities that are most evident during erection, which can lead to significant emotional distress, sexual dysfunction, and penile pain. Collagenase clostridium histolyticum (CCH) is indicated for the treatment of adult men with PD with a palpable plaque and curvature deformity of at least 30 degrees at therapy onset. Notably, men with ventral curvature (VC) were not included in the CCH clinical trial program due to potential concerns over the proximity of the urethra to the site of injection. Currently, CCH is contraindicated in Peyronie’s plaques that involve the penile urethra. Urethral involvement of a PD plaque is rare due to the anatomy of those structures. PD plaques form in the tunica albuginea as opposed to the corpus spongiosum which directly surrounds the urethra. Also, multiple prospective and retrospective studies have documented favorable outcomes using CCH for PD with VC. Thus, CCH may be a reasonable treatment option for patients suffering with ventral and ventrolateral penile curvatures in the absence of direct urethral involvement. Objective We are conducting a multicenter real-world retrospective collaborative research study of the safety and effectiveness of CCH in the treatment of men who had PD with VC. Methods A Phase 4, multicenter, noninterventional, retrospective review of medical records from approximately 10-15 US physician sites is being conducted. Eligible patients include those ≥18 years old with a PD diagnosis with VC and a palpable plaque that had been treated with CCH from 2014 to the study start date at the site. The primary effectiveness endpoint is percent change from (pretreatment) baseline in degree of VC at the last visit as measured at follow-up within 6 months post-treatment. Secondary endpoints include mean change from Baseline in VC and the proportion of patients with ≥30% improvement from baseline in VC at the last visit during which a measurement was collected within 6 months of final CCH treatment. Adverse events are collected throughout the study period to assess safety. Results In this first look at early data, 32 eligible patients with a median age (range) of 58.0 years (25-75 years) were included in the analysis. The percent change in penile curvature from baseline decreased, representing an improvement of 45.4% (SD: 28.62 [0-100]) (Figure), with 68.8% (22/32) of patients experiencing ≥30% improvement from baseline in VC. There were no serious adverse events. Five patients had at least one treatment-related adverse event (TRAE); 4 TRAEs were mild-to-moderate in severity and 2 were unknown. There were no reports of urethral involvement or injury. TRAEs were related to injection site bruising (n = 3), hemorrhage (n = 1), swelling (n = 1), and muscle spasm (n = 1). Conclusions This first look at early data reflecting improvements in men with PD and VC (data cutoff: 06/14/2024) is consistent with findings of effectiveness and tolerability of CCH in the treatment of men with dorsal and dorsolateral penile curvature. Disclosure Yes, this is sponsored by industry/sponsor: Endo USA Inc. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: MZ is an investigator and consultant for Endo USA Inc. MI is an investigator for Endo USA Inc. AT is an investigator and consultant for Endo USA Inc. RB is an investigator for Endo USA Inc. JM is an investigator and consultant for Endo USA Inc. JT is an employee of Endo USA Inc. DH is an employee of Endo USA Inc. GK is an employee of Endo USA Inc. KG is an investigator and consultant for Endo USA Inc. JA is an employee of Endo USA Inc. TR is an employee of Endo USA Inc. MA is an employee of Endo USA Inc. JM is an investigator for Endo USA Inc.
(137) COMPARISON OF COLLAGENASE CLOSTRIDIUM HISTOLYTICUM TO SURGERY FOR THE MANAGEMENT OF PEYRONIE’S DISEASE: A RANDOMIZED TRIAL – 2 YEAR OUTCOMES
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.
(138) EFFICACY OF A NOVEL COLLAGENASE CLOSTRIDIUM HISTOLYTICUM PROTOCOL FOR PEYRONIE’S DISEASE AMONG PRIOR NON-RESPONDERS: A RANDOMIZED, CONTROLLED, SINGLE-BLINDED STUDY
Abstract Introduction Limited data currently exist on the role and efficacy of additional series of collagenase clostridium histolyticum (CCH) injections among Peyronie’s disease (PD) men who have previously failed a first series of injections. We sought to evaluate outcomes of a novel protocol for CCH injections among men who had previously failed 6-8 CCH injections using a traditional approach. Objective To evaluate whether additional rounds of CCH using a novel protocol in men previously unresponsive results in greater curve improvements. Methods A randomized, controlled trial (NCT05108558) is ongoing. All participants previously failed to achieve ≥20% curvature improvement with 6-8 prior CCH injections. Men were randomized 3:1 to receive either CCH + traction (RestoreX) + sildenafil (treatment) up front or initial observation followed by treatment (controls). Outcomes were compared between treatment and control groups. Key measures included objective curve improvements and standardized/non-standardized questionnaires, with assessments obtained at baseline, 6-weeks after completion of CCH (treatment arm), after the no treatment period (controls), and at 1 year. Results A total of 38/40 men have been randomized to date, with 22 having fully completed treatment. Mean age was 57 years, with a median PD duration of 22 months. Median composite baseline curvature was 65 degrees, with 40% having hourglass or indentation deformities, 8% calcification, median baseline IIEF-EFD 20, and 58% able to have penetrative intercourse. Median estimated improvement with the prior CCH series was 0% (IQR 0, 18.8), and the median number of prior injections was 8. The majority of men were dissatisfied with their prior series of CCH (58% vs 35% satisfied, 8% neutral). Of the 22 men who had completed the study protocol, 50% required 1 series, 14% 2 series, 29% 3 series, and 7% 4 series. Compared to the no treatment arm, treated men experienced significantly greater improvements (median 60 degrees vs 0, p = 0.01). IIEF-EFD was non-statistically higher in treated men (0 vs -5, p = 0.17). 92% of men reported a subjective major improvement in curvature, with the median subjectively estimated improvement 90%. 42% reported improved sensitivity (58% no change), while 63% reported improved or no change in erectile function, with 9% unsure, and 27% worse. Post-treatment, 92% of men were very satisfied with CCH as a treatment and 8% neutral. Conclusions Repeating CCH using a novel protocol after an initially unsuccessful course of CCH achieves significant improvements in curvature and patient satisfaction. Additional data, including external validation, are warranted. 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.
(039) THE EFFICACY AND SAFETY OF OFFICE-BASED PENILE PLICATION
Abstract Introduction Penile plication is an excellent approach for patients with congenital penile curvature and Peyronie’s disease. Beginning in March of 2023, patients who were candidates for penile plication were offered the procedure in the operating room under general anesthesia or in the office setting with no sedation. Fourteen patients opted for the procedure in the clinic. Objective We therefore sought to assess patient responses and experience after undergoing surgery in the clinic setting. Methods Fifteen patients, ages ranging from 21 to 74 were seen in clinic for penile plication surgery. Exclusion criteria included patients younger than 18 years and preoperative systolic blood pressure greater than 160. One patient was noted to have a systolic blood pressure over 200 and thus was unable to have the procedure. Five patients had a penile plication for congenital curvature, eight patients for Peyronie’s disease, and 1 patient had a release of a previously placed palpable plication suture. Degree of curvature, direction of curvature, presence of secondary curvature, presence of hinge defect, and indentation were not considerations in patient selection. Three patients were on anticoagulation, which was held prior to surgery. Twelve patients underwent a ventral approach and two a degloving approach. Results Patients are allowed and encouraged to eat and drink prior to the procedure. All patients were given a preoperative antibiotic, normally either Bactrim or ciprofloxacin prior to the procedure and 20 mg of oral versed. They were then taken to the in-office procedure room after consent was obtained. The procedure room contains a television for patients to watch. At the end of the procedure, an Exparel block was performed. Patients are then prepped and draped in standard sterile fashion. A dorsal penile nerve block and circumferential block were utilized at the beginning of the case. A catheter is not placed to help reduce patient discomfort. Alprostadil is injected to help identify curvature. Ten patients were noted to have dorsal, 2 patients’ ventral, and 2 patients’ lateral curvature with degree of curvature ranging from 30 to 60 degrees. Eight patients had a secondary curvature identified. Total number of plication sutures utilized ranged from 2 to 8. All procedures were successfully conducted, and patients discharged home. Patients were then contacted to determine their experiences with the procedure. Only seven patients were able to be reached. One patient did have a vasovagal response in the procedure room, but this resolved with a small snack. Average intraoperative discomfort was rated as a 2/10 and was mainly present during the initial block. All patients stated that they would choose this surgical approach again and have noted clinically significant improvement to their curvature. Conclusions Penile plication in the clinic setting reduces anesthetic risks as well as costs associated with the operating room. This study shows the safety and feasibility of this approach. Disclosure No.