Citations

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.

Abstract Introduction Undergoing fertility testing can be a stressful event in a couple's life. This can impact multiple aspects of life, including sex. Objective To evaluate the relationship between stress and sexual function in men undergoing fertility testing. Methods We performed a review of a prospectively maintained database of men utilizing a mail-in semen analysis test system developed by Fellow Health, Inc. Those included consented to participate in research, were 18 or older, and completed survey questionnaires on both their quality of life and sexual function. Stress level (low, moderate, or high stress) was determined using the validated Perceived Stress Scale (PSS) 10-question survey. The sexual function survey assessed libido, orgasmic and ejaculatory dysfunction, intercourse frequency, Erection Hardness Score, and IIEF-5 score. Descriptive statistics were reported and chi-squared and t-tests were used to determine statistical significance at the 0.05 alpha level. Results A total of 2077 men undergoing fertility testing were included in this study. 50.2% reported moderate stress levels and 2.6% reported high stress levels. Those with low stress were older than those with moderate or high stress (average 35.4 vs. 34.3 and 34.0 years, respectively; p < 0.01). Men with high stress levels were more likely to report a “poor” or “terrible” libido (31.4%) compared to those with moderate or low stress, 17.2% and 9.5%, respectively (p < 0.01). Stress was highly associated with weekly intercourse frequency (p < 0.01): among men with high levels of stress, 25.5% reported having sex less than once a week compared to 6.0% of men with low stress. Likewise, no highly stressed men reported having sex more than six times per week compared to 2.8% of men with low stress. Whereas 80.4% of men with low stress were evaluated to have “No signs of ED” by the IIEF-5, the same was true for only 62.3% of moderately stressed men and 56.0% of highly stressed men (p < 0.01). Conclusions More than half of men undergoing fertility testing report increased levels of stress, which is negatively associated with libido and erectile function. In men seeking fertility evaluation, lifestyle factors such as stress levels should be assessed to identify patients who may benefit from stress management strategies. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Fellow Health.

Abstract Introduction Depression is a common mental health disorder affecting men of reproductive age. Depression or depressive symptoms may impact a variety of health factors, including sexual function. Trying to conceive may contribute to additional stress and negative emotions for the couple. Objective To determine the rate of sexual dysfunction in men with depression who are undergoing fertility testing. Methods A review was performed of a prospectively maintained database of men utilizing a mail-in semen analysis test system developed by Fellow Health, Inc. Men ≥18 years were included if they consented to participate in research and completed survey questionnaires on both their quality of life and sexual function. Depression level (normal, mild, moderate, or severe) was derived via the short-form depression assessment developed by the Patient Reported Outcomes Measurement Information System (PROMIS). The sexual function survey assessed libido, orgasmic and ejaculatory dysfunction, intercourse frequency, Erection Hardness Score, and IIEF-5 score. Descriptive statistics were reported and chi-squared tests were used to determine statistical significance at the 0.05 alpha level. Results Of the 2125 men included, 15.2% reported mild depression and 12.8% moderate or severe depression. The presence of depression was negatively associated with libido, with 11.2% of men with normal levels of depression reporting terrible or poor libido compared to 18.7% with mild depression and 22.2% with moderate or severe depression, p < 0.001. Compared to men without depression, those with moderate or severe depression were nearly twice as likely to report ejaculatory dysfunction (17.2% vs. 29.7%) and three times as likely to report orgasmic dysfunction (3.9% vs. 13.0%), p < 0.001 for all. Severity of depression was also predictive of an erection sufficient for penetration: whereas 96.8% of those with normal levels of depression reported an erection sufficient for penetration, the same could be said for only 94.5% of those with mild depression and 92.5% of those with moderate or severe depression (p < 0.001). Only 53.1% of men with moderate or severe depression had an IIEF-5 score greater than 21 (i.e., “No signs of ED”), compared to 60.9% with mild depression and 75.8% without depression, p < 0.001. Importantly, men with moderate to severe depression were more than twice as likely to report intercourse frequency less than once weekly (18.0%) as opposed to men without depression (7.4%), p < 0.001. Conclusions The presence of depression in men undergoing fertility testing is negatively associated with libido, ejaculatory, orgasmic, and erectile function. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Fellow Health.

Abstract Introduction Limited data exist on semen parameters post vasectomy reversal. Specifically, no studies have rigorously evaluated the likelihood of sperm return following discovery of azoospermia at some time point post vasectomy reversal. Objective To evaluate the rate of return of sperm among men who experience an azoospermia result post vasectomy-reversal. Methods A large, prospective dataset has been maintained of men undergoing vasectomy reversals at a single center from 2019 to the present. Men who had at least two post-operative semen analyses were included for review. The data were then analyzed in a manner to identify those who experienced a 0 count at varying time points and then either went on to continue to have 0’s beyond that point or who experienced a return of sperm. Results A total of 3414 men underwent a vasectomy reversal since 2019, with 2703 having semen analysis data available for review. Overall demographics demonstrated a mean age of 41, partner age 33, median time since vasectomy of 7 years, 92% first-time cases, and distribution of repair as noted: VV/VV (79%), VV/EV (12%), EV/EV (6%), VV/x (1%), EV/x (<1%), x/x (0%). Of men who had 0 sperm at varying time points, the percentages of those who experienced a return of sperm are noted as follows: 0 sperm at <2 months (52% experienced a return at some point, n = 349 used in calculation), 0 at 2-4 months (38% return, n = 210), 0 at 5-7 months (17% return, n = 206), 0 at 8-10 months (20% return, n = 133), 0 at 11-18 months (9% return, n = 107). The data are limited by the fact that relatively few men continued to send in semen analysis samples beyond 12 months (n = 403 with at least one result >12 months and n = 101 with results >24 months). Conclusions Men who experience azoospermia post-vasectomy reversal may experience a return of sperm over time, with the likelihood for return declining based on the duration of persistence of 0 sperm. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: PathRight Medical.

Abstract Introduction Microdissection testicular sperm extraction (microTESE) is performed in men with nonobstructive azoospermia who desire sperm retrieval for use in IVF. This procedure can be performed in the operating room or in the clinic with local analgesic. Objective To report office-based microTESE sperm retrieval, fertilization, and livebirth rates. Methods A review was conducted of all patients who underwent office-based microTESE for nonobstructive azoospermia with a partner that who underwent concurrent oocyte retrieval for an intended in-vitro fertilization (IVF) intracytoplasmic injection (ICSI) cycle 2022-2024. All male partners underwent Y chromosome microdeletion testing, karyotype analysis, and hormonal testing preoperatively. Patients with a diagnosis of hypogonadism were offered medical therapy and those diagnosed with a varicocele were offered varicocelectomy prior to microTESE. Office-based microTESE was performed using a surgical operating microscope, spermatic cord block, and oral anxiolytic. Female partners underwent oocyte retrieval with oocyte cryopreservation prior to microTESE. Oocyte warming and ICSI was performed only following the collection of motile sperm from the fresh microTESE samples. Relevant demographic and clinical data were collected for patients and their partners. Descriptive data analysis was performed and reported as mean ± standard deviation. Results Ten patients underwent 11 office-based microTESE procedures. One patient had repeat microTESE following an unsuccessful IVF/ICSI cycle. Overall sperm retrieval rate was 70% for first time microTESE with mean search time 197.2 ± 96.5 min. Amongst couples with successful sperm retrieval, normal fertilization rate was 42%. Early cleavage arrest was seen in 84% of normally fertilized oocytes with a 16% blastocyst rate. Embryo development arrested entirely in two couples, while the remaining five couples had at least one blastocyst on day 5 and underwent embryo transfer. Of these, four resulted in a clinical pregnancy (36%). Three couples had a successful live birth and one has an ongoing pregnancy with ultrasound-confirmed fetal heartbeat. Conclusions Our small series demonstrates high sperm retrieval rates from office-based microTESE. Fertilization rates, clinical pregnancies and live birth rates are comparable with those reported in the literature. Given the financial cost associated with microTESE and IVF/ICSI for nonobstructive azoospermia patients, office-based microTESE may be a solution to make the process more financially accessible for couples. Disclosure No.