Citations

Abstract Introduction Intracavernosal injections (ICI) is a well-established treatment for erectile dysfunction with common complications including priapism, penile ecchymosis and injection site pain. A rarer complication is breakage and retention of the needle inside the penis during self-injection, with only 16 cases reported in the literature from 1991 to 2023. Objective To report a case of needle breakage and retention as a complication of ICI and describe the optimal management of retained needle in the penis. Methods A 69-year-old male with a history of erectile dysfunction on TriMix presented to the Urology Department after half of his ICI needle broke off in the right side of his penis following self-injection. He denied having any pain or discomfort but reported that a small nodule had formed at the site. On physical examination, a nodule was palpated at the right base of his penis. He underwent pelvic X-ray and penile ultrasound, noting a 4-5 mm foreign body in the right base of the penis without gas in the soft tissue. As the retained needle was not significantly affecting him, he decided not to proceed with intervention and continued with ICI on the contralateral side. He began noticing burning pain at the site of injection, with development of a hard nodule that self-resolved each time. Due to worsening erectile function, he returned to clinic one year later to discuss inflatable penile prosthesis placement, where he inquired about removal of the retained needle. A small, nontender nodule was still noted at the right base of the penis. Results The patient underwent penile exploration in the operating room, revealing an obvious inflammatory fibrous nodule at the right base of the penis corresponding to the location of the needle on previous ultrasound. There was also a similar, smaller nodule contralaterally where the patient had continued ICI. Ultrasound guidance was used intraoperatively to identify the needle, then a spinal needle was used to triangulate with the needle fragment. The penis was sharply dissected along the spinal needle with iris scissors until the 4 mm needle fragment was identified and removed in its entirety. Dissection then began to excise the inflammatory nodule. However, despite attempts to completely mobilize Buck’s fascia and the nerves, the neurovascular bundles were quite adherent to the nodule from an inflammatory reaction and thus it was unable to be excised. A small possible corporotomy was then identified and repaired using 2-0 PDS. Injectable saline was then used to induce an erection and confirm no defects in the corpora. The patient recovered well post-operatively without any complications, and the nodules were noted to be much smaller at his one-month postoperative visit. Conclusions ICI needle breakage and entrapment in the penis is a rare complication. The diagnosis of needle retention includes imaging such as pelvic radiographs or penile ultrasound to locate the needle. While less invasive approaches can be attempted for removal, they may be less effective and cause further damage to surrounding tissue. Surgical exploration under ultrasound guidance is a safe and effective approach to needle removal. Disclosure No.

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.

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.

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.

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 Recent literature suggests growing rates of malpractice claims against Urologists, with the incidence of being sued seeming to be unrelated to one’s professional reputation. These cases provide insight into errors that may lead to litigation. Given national trends of rising malpractice cases, estimates that a Urologist can expect to be sued at least twice in their careers are likely underestimates. Malpractice cases can give insight into the common medical errors rising to the level of litigation. Given the elective nature of procedures within sexual medicine, understanding litigation related to these cases is crucial. Objective We aim to analyze malpractice suits related to men’s health and highlight clinical presentations and legal outcomes. Methods Per STROBE guidelines, we searched the publicly available Thomson Reuters Westlaw legal database for “jury verdicts and settlements” from January 1970 to August 2023 to identify medical malpractice cases in Urology. Patient demographics, clinical presentation, alleged error, and legal outcomes were abstracted during full case review by an independent screener. Cases related to men’s sexual health or fertility that named a urologist as the defendant were fully analyzed. Results A total of 553 Urology cases were extracted, with 23 men’s health related cases subsequently analyzed and summarized in Table 1. The most common conditions associated with litigation were erectile dysfunction (penile prosthesis) (39%), epidydimal pathology (13%), and varicocele (13%). The most common allegations were misdiagnosis (26%), surgical complication (22%), lack of informed consent (22%), and violation of standard of care (22%). Of the 23 cases, 57% ruled “no liability” in favor of the urologist, 39% ruled in favor of the plaintiff with a median award of $335,000 (IQR = 100,000-450,000), and one was settled for $316,338. Among cases ruled as negligent, performing the incorrect procedure, surgical complications, and violating the standard of care were prominent allegations. Florida (26%) and Pennsylvania (17%) had the most cases in this sample. Of note, there were no cases for penile plication, plaque excision, microsurgical cord denervation, vasectomy reversal, or sperm retrieval, and only one for vasectomy. Conclusions This study characterizes malpractice cases related to men’s sexual health naming urologists as defendants. Despite fear of litigation, this review of the Westlaw database revealed only 23 cases related to men’s health since 1970. Moreover, the majority of cases ruled in favor of the Urologist. Obtaining comprehensive informed consent, following national guidelines, and responding appropriately to surgical complications may minimize likelihood of litigation and maximize patient outcomes. Disclosure No.

Abstract Introduction The Electronic Medical Record (EMR) has had a positive impact on healthcare but it has also increased administrative burden on physicians. One reason for this is the patient portal, which grants patients 24/7 access to ask their physician questions. Objective To characterize the patient message volume of urologists with a Men’s Health Practice by quantifying message volume per case, identifying procedures linked to high message volume, and examining demographics affecting patient portal use. We then assess the clinical utility of patient portal messages by examining their effect on Emergency Department (ED) utilization. Methods We queried the EMR of a health system spanning the southeast, midwest, and southwest using internal procedure and surgical codes for all office and operating room based urologic procedures from March 2017-November 2023. We identified procedures related to Men’s Health focusing on andrology, sexual medicine, and male reconstructive procedures. Patients identifying as women, those with multiple procedures within 6 months, and patients without research authorization were excluded. To identify factors associated with active portal users and message volume, we performed univariate and multivariable logistic and linear regression models. Multivariable models consisted of all statistically significant factors on univariate analysis. In models utilizing the procedure variable to compare message volume, vasectomy was chosen as the reference procedure due to it having the highest case volume. To assess the impact of active portal use (defined as sending at least 1 message within 6 months of their procedure) on risk of subsequent ED visit, we performed univariate Kaplan–Meier analysis and univariate and multivariable Cox Proportional Hazard models treating portal use as a time-dependent covariate. Results We examined 16,299 procedures which generated 49,422 messages within 6 months of their procedure (Table 1). Demographic data can be seen in table 2. On average, 3.04 ± 6.88 messages were generated after each procedure. The highest message generating procedures were testosterone Injection/pellets (5.83 ± 9.57), Itind (5.73 ± 14.18), and Transurethral Incision of the Prostate (5.19 ± 13.19). The lowest message generating procedures were vasectomy (1.30 ± 3.10), spermatocelectomy (1.67 ± 3.80), and circumcision (2.32 ± 5.26). The types of cases that generated the highest overall message burden were male reconstructive procedures (4.53 ± 8.57) and BPH procedures (4.07 ± 8.40) and. Slightly less than half of our cohort were active on the portal (45%) within 6 months of their procedure (Table 1). The procedures that were the most likely to have active portal users were microtese (OR 5.03 95% CI 2.38,10.67), testosterone injection/pellets (OR 4.86 95% CI 3.13, 7.54), and Itind (OR 3.02 95% CI 2.16, 4.24). On time to event analysis we found that portal usage decreased the risk of presenting to the Emergency Department (ED) by 15% within 90 days of their procedure [HR (95% CI) 0.65 0.85 (0.77, 0.93)] (Fig. 1). Conclusions Urologists practicing Men’s Health receive a high number of messages per procedure that they perform, however the use of the patient portal reduces ED utilization. Resources should be allocated to help urologists manage their patient messages as it lowers healthcare costs. Disclosure No.

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.

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 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.