Oral phosphodiesterase type 5 inhibitors and priapism: A VigiBase analysis.

PURPOSE: To explore the differences of priapism events among a diverse cohort taking erectogenic medicines (i.e., phosphodiesterase type 5 inhibitors [PDE5i] and intracavernousal drugs). METHODS: We queried the World Health Organization global database of individual case safety reports (VigiBase) for records of the adverse drug reactions (ADR) with sildenafil, tadalafil, avanafil, vardenafil, papaverine, and alprostadil. Disproportionality analyses (case/non-case approach) were performed to assess the reporting odds ratio (ROR) of priapism reporting in PDE5i consumers compared to intracavernousal drug recipients. RESULTS: From a total of 133 819 ADR events for erectogenic medications, 632 were priapism (PDE5is: n = 550, 0.41%; intracavernousal drugs: n = 82, 9.92%). Priapism disproportionality signals from intracavernousal drugs were 25 times stronger than PDE5is (ROR = 34.7; confidence interval [CI] 95%: 27.12-43.94 vs. ROR = 1.38; 95% CI: 1.24-1.54). For all PDE5i agents, the 12-17 years age group had the highest ROR (9.49, 95% CI: 3.76-19.93) followed by 2-11 years (4.31, 95% CI: 1.57-9.4). Disproportionality signals for consumers under 18 for both all PDE5is as a whole (ROR = 4.57, 95% CI: 2.48-7.73) and sildenafil (ROR = 4.89, 95% CI: 2.51-8.62) were stronger than individuals 18 or older (ROR = 1.06, 95% CI: 0.93-1.21 and ROR = 1.08, 95% CI: 0.91-1.26, respectively). CONCLUSIONS: PDE5i use shows disproportionate priapism signals which are higher in young patients.

Conservative Management of Penile and Urethral Lichen Sclerosus: A Systematic Review.

PURPOSE: We evaluate the efficacy and safety profiles of currently available conservative management options for penile and urethral lichen sclerosus. MATERIALS AND METHODS: A systematic review of existing literature on lichen sclerosus was conducted utilizing the PubMed, Embase, and Web of Science databases. References were assessed for relevance to nonsurgical management of male genital lichen sclerosus by title and abstract by 3 independent reviewers, then reviewed in full and in duplicate by 5 independent reviewers. RESULTS: Seventeen studies describing conservative management of histologically confirmed penile and urethral lichen sclerosus in male patients were included in the final review. We present available evidence supporting the use of 4 major treatment modalities represented in the existing literature: topical corticosteroids, tacrolimus, platelet-rich plasma, and CO2 laser. We also briefly discuss the limited studies on the use of oral acitretin and polydeoxyribonucleotide injections. Outcomes assessed include symptoms, clinical appearance, quality of life, sexual satisfaction, adverse effects, and long-term efficacy of treatment. CONCLUSIONS: Topical corticosteroids remain the mainstay of conservative management of penile and urethral lichen sclerosus, with current literature supporting the use of other therapies such as tacrolimus and platelet-rich plasma as alternatives or adjuvant treatments when escalation of treatment is necessary. Future research should further explore the efficacy and safety of newer therapies through additional controlled clinical trials in the targeted population.

Urethral Slings for Irradiated Patients With Male Stress Urinary Incontinence: A Meta-analysis.

OBJECTIVE: To systematically compare success, cure and complication rates of urethral sling surgeries in stress urinary incontinence patients with and without a history of pelvic radiotherapy (RT). MATERIALS AND METHODS: We searched PUBMED, EMBASE, and Web of Science to identify relevant articles. The primary outcomes were the success and cure rates. The secondary outcomes included the rates of infection, urethral erosion, total complications, explantation, and satisfaction. Outcomes were analyzed using a random-effects model to calculate the unadjusted odds ratio (OR) in patients with a history of RT compared with those without prior RT. RESULTS: On pooled analysis, we found significantly lower odds of success (OR 0.68; 95% confidence interval [CI] 0.53-0.87, P < .001) and cure (OR 0.67; 95% CI 0.55-0.82, P < .001) in radiated patients than in nonirradiated patients. Subgroup analysis by type of sling showed significantly lower odds of success in Advance subgroup (OR 0.66; 95% CI 0.45-0.95, P < .001) and significantly lower odds of cure in Advance (OR 0.59; 95% CI 0.36-0.95, P < .001) and Atoms subgroups (OR 0.70; 95% CI 0.54-0.93, P < .001). We also found significantly greater odds of sling explantation (OR 2.93; 95% CI 1.62-5.29, P < .001) and infection (OR 3.06, 95% CI 1.03-9.07, P < .001) in radiated patients than in nonradiated patients. CONCLUSION: Patients with a history of pelvic RT have lower odds of success and cure and higher odds of infection and sling explantation than those without a history of pelvic RT.

Grade V renal trauma management: results from the multi-institutional genito-urinary trauma study.

PURPOSE: To investigate management trends for American Association for the Surgery of Trauma (AAST) grade V renal trauma with focus on non-operative management. METHODS: We used prospectively collected data as part of the Multi-institutional Genito-Urinary Trauma Study (MiGUTS). We included patients with grade V renal trauma according to the AAST Injury Scoring Scale 2018 update. All cases submitted by participating centers with radiology images available were independently reviewed to confirm renal trauma grade. Management was classified as expectant, conservative (minimally invasive, endoscopic or percutaneous procedures), or operative (renal-related surgery). RESULTS: Eighty patients were included, 25 of whom had complete imaging and had independent confirmation of AAST grade V renal trauma. Median age was 35 years (Interquartile range (IQR) 25-50) and 23 (92%) had blunt trauma. Ten patients (40%) were managed operatively with nephrectomy. Conservative management was used in nine patients (36%) of which six received angioembolization and three had a stent or drainage tube placed. Expectant management was followed in six (24%) patients. Transfusion requirements were progressively higher with groups requiring more aggressive treatment, and injury characteristics differed significantly across management groups in terms of hematoma size and laceration size. Vascular contrast extravasation was more likely in operatively managed patients though a statistically significant association was not found. CONCLUSION: Successful use of nonoperative management for grade V injuries is used for a substantial subset of patients. Lower transfusion requirement and less severe injury radiologic phenotype appear to be important characteristics delineating this group.

The Impact of Patient Travel Distance on Outpatient Visit Satisfaction: Comparison of Telehealth and Traditional In-Person Visits.

Introduction: Patient satisfaction has been shown to changes based on the distance a patient to see their physician. We sought to examine the effects of telehealth on patient satisfaction. Methods: We examined patient satisfaction survey scores from outpatient clinics at University of California, San Francisco. Patient home and clinic addresses were used to calculate distance in kilometers (km). Outcomes were "top scores (9-10)" and "low scores (<9)." Results: Of 103,124 evaluations that met inclusion criteria, those where patient traveled >100 km for in-person visits had more top scores (84%) than those traveled <10 km (80.2%). Relative to in-person visits, telehealth was associated with an increased odds (odds ratio [OR]: 1.48) of receiving a top score at all distances. Those traveling >100 km had the highest odds of top score for telehealth (OR: 1.86). Conclusions: Patients receiving care through telehealth, particularly those far from the outpatient clinic, are more likely to provide high patient satisfaction scores for the visit provider.

Adverse reactions of PDE5 inhibitors: An analysis of the World Health Organization pharmacovigilance database.

BACKGROUND: Despite their efficacy and general safety, rare but devastating adverse drug reactions have been associated with phosphodiesterase type 5 inhibitors. OBJECTIVES: To determine the safety profile of oral phosphodiesterase type 5 inhibitors with a particular focus on priapism and malignant melanoma. MATERIALS AND METHODS: In this case-non-case study, we queried the individual case safety reports for phosphodiesterase type 5 inhibitors within the World Health Organization global database of individual case safety reports (VigiBase) between 1983 and 2021. We included all individual case safety reports for sildenafil, tadalafil, vardenafil, and avanafil in men. For comparison, we also extracted the safety data from the Food and Drug Administration trials for these drugs. We assessed the safety profile of phosphodiesterase type 5 inhibitors by disproportionality analysis by measuring reporting odds ratio for their most commonly reported adverse drug reactions, once for all phosphodiesterase type 5 inhibitor reports and once for reports of oral phosphodiesterase type 5 inhibitor use in adult men (≥18 years old) with sexual dysfunction. RESULTS: A total of 94,713 individual case safety reports for phosphodiesterase type 5 inhibitors were extracted. A total of 31,827 individual case safety reports were identified relating to adult men taking oral sildenafil, tadalafil, vardenafil, or avanafil for sexual dysfunction. The most common adverse drug reactions included poor drug efficacy (42.5%), headache (10.4% vs. 8.5%-27.6% [Food and Drug Administration]), abnormal vision (8.4% vs. ≤4.6% [Food and Drug Administration]), flushing (5.2% vs. 5.1%-16.5% [Food and Drug Administration]), and dyspepsia (4.2% vs. 3.4%-11.1% [Food and Drug Administration]). Priapism showed significant signals for sildenafil (reporting odds ratio = 13.81, 95% confidence interval: 11.75-16.24), tadalafil (reporting odds ratio = 14.54, 95% confidence interval: 11.56-18.06), and vardenafil (reporting odds ratio = 14.12, 95% confidence interval: 8.36-22.35). Comparing with other medications in VigiBase, sildenafil (reporting odds ratio = 8.73, 95% confidence interval: 7.63-9.99) and tadalafil (reporting odds ratio = 4.25, 95% confidence interval: 3.19-5.55) had significantly higher reporting odds ratios for malignant melanoma. CONCLUSION: Phosphodiesterase type 5 inhibitors show significant signals correlating with priapism among a large international cohort. Further clinical study is needed to elucidate whether this is from proper or inappropriate use or other confounding conditions, as analysis of pharmacovigilance data does not allow for quantifying the clinical risk. Also, there appears to be a relationship between phosphodiesterase type 5 inhibitor use and malignant melanoma, which warrants additional study to better understand causation.

Radiation-induced Fistulas in Patients With Prior Pelvic Radiotherapy for Prostate Cancer: A Systematic Review and Meta-analysis.

OBJECTIVE: To systematically aggregate and summarize existing data on fistula prevalence among patients with a history of pelvic radiotherapy for prostate cancer. MATERIALS AND METHODS: We queried PubMed, Embase, and Web of Science on October 7, 2020 for peer-reviewed publications pertaining to radiation-induced fistulas in the pelvis. For meta-analysis, we used the random-effects model. We used the I2 statistic to quantify heterogeneity and the Newcastle-Ottawa Scale to assess risk of bias. RESULTS: Our final meta-analysis included 6 cohort studies with a total of 7665 patients exposed to pelvic radiotherapy between 1967 and 2013. Median follow-up time was 35.5 months (IQR 33.5-57.5). Pooled prevalence of radiation-induced fistula across all 6 cohort studies was 0.2% (95% CI: 0.1-0.4, I2 = 0.000%, P < .608). In subgroup analysis, we did not detect significant heterogeneity in fistula prevalence in patients who were re-irradiated (0.3%, 95% CI: 0.1-0.4; P = .762) or patients on concurrent chemotherapy (0.4%, 95% CI: -0.3 -1.2; P = .664) compared to those receiving their first course of radiotherapy alone. No randomized controlled trials met inclusion criteria due to ambiguous and inconsistent reporting language for fistula occurrence. CONCLUSION: There is limited published literature reporting fistula as an adverse event of prostate cancer radiotherapy, especially in the medium and long-term period. Patients undergoing pelvic radiotherapy for prostate cancer appear at low short-term risk for developing fistulas. Adverse event reporting in randomized controlled trials merits greater granularity where fistulas should be reported with specificity rather than aggregating into broad categories of genitourinary or gastrointestinal adverse events.

Alpha-Lipoic Acid Supplementation for Male Partner of Couples with Recurrent Pregnancy Loss: A Post hoc analysis in Clinical Trial.

BACKGROUND: Increased sperm DNA damage is known as one of the causes of recurrent pregnancy loss (RPL) which can be due to increased levels of oxidative stress. Therefore, the aim of this study was to assess the effect of alpha-lipoic acid (ALA) on sperm parameters and sperm functions in couples with a history of RPL. MATERIALS AND METHODS: In this post hoc analysis in clinical trial study, a total of 37 couples with RPL (n=12 and n=25 for placebo and ALA groups, respectively) were considered. Men were treated with ALA (600 mg/day) or placebo for 80 days. Semen samples were acquired from the participants before initiation and after completion of the medication course and assessed regarding conventional sperm parameters, chromatin damage/integrity, intracellular oxidative stress, lipid peroxidation, and seminal antioxidant characteristics. Individuals were further followed up for twelve months for pregnancy occurrence and outcomes. Finally, after excluding patients with no history of RPL, the data was analyzed. RESULTS: No significant differences were observed between the baseline measures of the aforementioned parameters except for seminal volume. After the intervention, the mean sperm DNA damage, protamine deficiency, and persisted histones were significantly lower in the ALA group than in placebo receivers (P<0.05). A decrease in the mean of seminal total antioxidant capacity (P=0.03), malondialdehyde (P=0.02), and sperm DNA damage (P=0.004) as well as an increase in sperm total motility (P=0.04) after treatment with ALA was noticed. In addition, the mean of protamine deficiency and persisted histones were declined post-ALA therapy (P=0.003 and 0.002, respectively). The percentage of spontaneous pregnancy in the ALA group (4 of 25 cases; 16%) was higher than in the placebo group (1 of 12, 8.3%). CONCLUSION: ALA-therapy attenuates sperm DNA damage and lipid peroxidation while enhancing sperm total motility and chromatin compaction in the male partner of couples with PRL (registration number: IRCT20190406043177N1).

Role for Conservative Management in Grade V Renal Trauma.

PURPOSE: We assessed the use of conservative management for American Association for the Surgery of Trauma grade V renal trauma in the National Trauma Databank. MATERIALS AND METHODS: We used data of grade V renal trauma patients in the 2017-2019 National Trauma Databank. Conservative management was defined by the absence of surgical or procedural intervention except for ureteral stent or percutaneous drain placement. We initially analyzed patients who survived to final hospital discharge and reported the percent utilization of conservative management. We then repeated our analysis in the overall grade V population and in all those who did not die in the emergency department. RESULTS: Of 1,474 who survived to discharge, 557 (37.8%) patients were managed conservatively. In the adjusted analysis, penetrating trauma mechanism (OR 0.13, 95% CI 0.09-0.19, P < .001) and receiving transfusion (OR 0.22, 95% CI 0.17-0.29, P < .001) were associated with decreased odds of receiving conservative management. Overall, there were 1,919 patients with grade V injury, of whom 731 (38.1%) were managed conservatively. Mortality rate was 22.8% in those managed conservatively vs 23.8% in those who had intervention. After excluding 110 patients who died in the emergency department, there were 1,809 patients, of whom 625 (34.6%) were managed conservatively. Mortality rate was 22.6% in the operatively managed group and 10.9% in the conservatively managed group. CONCLUSIONS: A substantial portion of grade V renal trauma cases were managed successfully without intervention in the National Trauma Databank. Further research is needed to identify radiological phenotypes suitable for nonoperative management and to overcome possible renal trauma grade misclassification.

Alpha-Lipoic Acid Ameliorates Sperm DNA Damage and Chromatin Integrity in Men with High DNA Damage: A Triple Blind Randomized Clinical Trial.

OBJECTIVE: Evidence suggests the contributory role of oxidative stress (OS) to sperm DNA damage and eventually, male infertility. Antioxidant supplementation has exhibited favorable results regarding seminal OS, sperm DNA damage, and chromatin integrity. We aimed to evaluate the effect of alpha-lipoic acid (ALA) supplementation on semen analysis, sperm DNA damage, chromatin integrity, and seminal/intracellular OS in infertile men with high sperm DNA damage. MATERIALS AND METHODS: In this randomized triple-blind placebo-controlled clinical trial study, we opted for a triple-blind controlled clinical trial design. Considering the study's inclusion criteria for the level of sperm DNA fragmentation (higher than the threshold of 30 and 15%), 70% of participants were selected for this clinical research study. Subjects were divided into case and control groups receiving oral ALA (600 mg/day) and placebo for eighty days, respectively. Sperm parameters and functional tests were examined and compared before and after treatment. The final sample size was 34 and 29 for ALA and placebo receivers, respectively. RESULTS: No significant differences were observed about anthropometrics and baseline measures of semen analysis, DNA damage, OS, and chromatin integrity between the two groups. Conventional semen parameters were enhanced insignificantly in both groups (P>0.05). DNA damage decreased significantly in the ALA group, as per sperm chromatin structure assay (SCSA, P<0.001). Moreover, chromomycin A3 (CMA3) staining results indicated a decrease in nuclear protamine deficiency post-ALA therapy (P=0.004). Lipid peroxidation decreased significantly after treatment with ALA (P=0.003). Further, seminal antioxidant capacity/activity did not differ significantly in either of the groups (registration number: IRCT20190406043177N1). CONCLUSION: An 80-day course of oral ALA supplementation (600 mg/day) alleviates sperm OS, DNA damage, and chromatin integrity in men with high sperm DNA damage.

Alcohol Intoxication Is Associated With Bladder Injury and Bladder Surgical Repair in Patients Sustaining Motor Vehicle Collisions.

PURPOSE: Alcohol intoxication is a known risk factor for motor vehicle collisions. We hypothesize ethanol intoxication increases the risk of bladder injury and surgical repair, especially at higher blood alcohol content levels. MATERIALS AND METHODS: We identified all patients involved in motor vehicle collisions from the National Trauma Data Bank from 2017-2019. Patients were categorized into an intoxication and intoxication negative group. Variables collected included age, sex, blood alcohol content level, driver status, seat belt restraint use, nonalcoholic intoxication, pelvic fracture, and Injury Severity Scale. Primary outcome measures of bladder injury and bladder surgical repair were assessed and interaction with pelvic fracture and restraint use were measured. RESULTS: We identified 594,484 patients and 97,831 (16.5%) had a positive alcohol screen. Patients in the intoxication group were more likely to be intoxicated with other substances (32.8% vs 14.6%, P < .001), have a bladder injury (1% vs 0.4%, P < .001) and receive bladder surgical repair (0.7% vs 0.15%, P < .001). Injury Severity Scale and pelvic fracture were statistically significant predictors of bladder injury. In adjusted analysis, higher blood alcohol content was associated with both outcomes. Above the legal limit, alcohol intoxication was more predictive of bladder surgical repair than pelvic fracture. The association of alcohol intoxication with both outcomes did not differ by pelvic fracture, but strengthened with seat belt use at higher intoxication levels. CONCLUSIONS: Alcohol intoxication is independently associated with increased risk of bladder injury and subsequent bladder surgical repair following motor vehicle collisions. Trauma providers should have a high index of suspicion for bladder injuries in alcohol intoxicated patients, particularly those using seat belt restraints.

Posterior urethral stenosis: a comparative review of the guidelines.

PURPOSE: We aimed to provide a thorough comparative review of the available guidelines on the diagnosis, management, and follow-up for patients with posterior urethral stenosis by the American Urologic Association (2016), Société Internationale d'Urologie (2010), and European Urologic Association (2022). METHODS: The AUA, SIU, and EAU guidelines were evaluated for recommendations on the diagnosis, evaluation, and treatment of posterior urethral stenosis. We also included the EAU and AUA urologic trauma guidelines for the trauma-related stenosis. The level or strength of recommendations is included in case of disparity between the guidelines. RESULTS: The three guidelines align considerably in recommendations provided for the diagnosis, management, and follow-up of patients with posterior urethral stenosis. SIU and EAU emphasize the role of repeat endoscopic treatment in guidelines compared to AUA. CONCLUSION: The preferred method to repair bulbo-membranous stricture/stenosis following radiation therapy remains an area of active interest, focusing on continence preservation. Additionally, there may be a role for advanced endoscopic treatments with or without adjunct therapies to manage even obliterated stenoses.

COVID-19 Misinformation and Social Network Crowdfunding: Cross-sectional Study of Alternative Treatments and Antivaccine Mandates.

BACKGROUND: Crowdfunding is increasingly used to offset the financial burdens of illness and health care. In the era of the COVID-19 pandemic and associated infodemic, the role of crowdfunding to support controversial COVID-19 stances is unknown. OBJECTIVE: We sought to examine COVID-19-related crowdfunding focusing on the funding of alternative treatments not endorsed by major medical entities, including campaigns with an explicit antivaccine, antimask, or antihealth care stances. METHODS: We performed a cross-sectional analysis of GoFundMe campaigns for individuals requesting donations for COVID-19 relief. Campaigns were identified by key word and manual review to categorize campaigns into "Traditional treatments," "Alternative treatments," "Business-related," "Mandate," "First Response," and "General." For each campaign, we extracted basic narrative, engagement, and financial variables. Among those that were manually reviewed, the additional variables of "mandate type," "mandate stance," and presence of COVID-19 misinformation within the campaign narrative were also included. COVID-19 misinformation was defined as "false or misleading statements," where cited evidence could be provided to refute the claim. Descriptive statistics were used to characterize the study cohort. RESULTS: A total of 30,368 campaigns met the criteria for final analysis. After manual review, we identified 53 campaigns (0.17%) seeking funding for alternative medical treatment for COVID-19, including popularized treatments such as ivermectin (n=14, 26%), hydroxychloroquine (n=6, 11%), and vitamin D (n=4, 7.5%). Moreover, 23 (43%) of the 53 campaigns seeking support for alternative treatments contained COVID-19 misinformation. There were 80 campaigns that opposed mandating masks or vaccination, 48 (60%) of which contained COVID-19 misinformation. Alternative treatment campaigns had a lower median amount raised (US $1135) compared to traditional (US $2828) treatments (P<.001) and a lower median percentile of target achieved (11.9% vs 31.1%; P=.003). Campaigns for alternative treatments raised substantially lower amounts (US $115,000 vs US $52,715,000, respectively) and lower proportions of fundraising goals (2.1% vs 12.5%) for alternative versus conventional campaigns. The median goal for campaigns was significantly higher (US $25,000 vs US $10,000) for campaigns opposing mask or vaccine mandates relative to those in support of upholding mandates (P=.04). Campaigns seeking funding to lift mandates on health care workers reached US $622 (0.15%) out of a US $410,000 goal. CONCLUSIONS: A small minority of web-based crowdfunding campaigns for COVID-19 were directed at unproven COVID-19 treatments and support for campaigns aimed against masking or vaccine mandates. Approximately half (71/133, 53%) of these campaigns contained verifiably false or misleading information and had limited fundraising success. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1001/jamainternmed.2019.3330.

Impact of the COVID-19 pandemic on emergency department visits for genitourinary trauma.

INTRODUCTION: The mean number of emergency department visits for all-cause traumas has declined significantly during the COVID-19 pandemic. We aim to identify how a global pandemic and social distancing could affect the trends and pattern of genitourinary traumas. METHODS: We queried the National Electronic Injury Surveillance System to obtain consumer product-related genitourinary injuries leading to emergency department visits. Using three key events in 2020, we divided the study period to three intervals: January 20, when the first COVID-19 case was confirmed in the United States; March 13, when a national state of emergency was declared; April 20, when Texas became the first state to start a phased reopening of economy. We compared the injury characteristics in 2020 to their identical intervals in 2019. RESULTS: Daily emergency department visits dropped significantly during the national lockdown (mean 131.5 vs. 78; Δ-40.7%; p < 0.01). The genitourinary injuries decreased significantly in children ≤ 17 years (p < 0.01), males (p < 0.001), and White population (p < 0.01). However, it did not change significantly in adults 18-64 years (p = 0.92), old adults ≥ 65 years (p = 0.37), females (p = 0.60), Black population (p = 0.90), other/unknown races (p = 0.93), and for injuries sustained at home (p = 0.75) and public (p = 0.11) locations. During the lockdown period, injuries associated with toilets/toilet seats (- 320, - 74.6%), day wear (- 266, - 77.7%), beds/bedframes (- 209, - 64.2%) decreased while injuries associated with knickknacks/statues/vases (+ 154, n/a), sofas/couches/divans (+ 130, 2,684%), and razors/shavers (+ 99, n/a) increased. CONCLUSIONS: The COVID-19 lockdown had a significant impact on genitourinary traumas. The contributing factors could be investigated further to prevent such injuries during deconfinement periods.

Incidence of venous thromboembolism in benign urologic reconstructive cases.

PURPOSE: To evaluate the rate of perioperative venous thromboembolism (VTE) among patients undergoing common benign urologic reconstructive cases. We hypothesize that this rate will be lower than previously described. METHODS: We utilized the American College of Surgeons National Surgical Quality Improvement Project database from 2015 to 2019 to evaluate 30-day perioperative risk of VTE. Patients ≥ 18 years old undergoing benign urologic reconstructive cases were selected using Current Procedural Terminology (CPT) codes. Demographic, comorbidity, and operative variables were captured. The primary outcome was VTE within the 30-day postoperative period. RESULTS: We identified 8467 patients who met inclusion criteria. The majority of patients were male (> 95%) with an average age of 65 and BMI of 29.6. There were 23 VTE events (0.27%) within the 30-day perioperative period. Fourteen (14/59) procedures had a perioperative VTE. Many of the traditional factors for VTE including operative time and obesity significantly increased risk of VTE in univariate analysis. In multivariate analysis, only BMI (OR 1.09; 95% CI 1.01-1.12) and inpatient status (OR 4.42; 95% CI 1.9-10.2) were correlated with increased perioperative VTE. CONCLUSION: The rate of VTE among patients undergoing benign urologic reconstructive cases is low. Providers should continue to have high index of suspicion particularly for inpatients with high BMI in addition to other known risk factors for VTE.

Foley Catheter Balloon Rupture and Risk of Free Fragment Formation.

OBJECTIVES: To assess the volume of foley catheter balloon rupture and the incidence of free fragment formation. MATERIALS AND METHODS: Forty Latex and 30 Silicone catheters of common sizes (14-20 French) were inflated with sterile water in an aqueous environment without positive pressure. Catheters producing fragments, fragment size, and maximum instilled volume prior to rupture ("burst volume") were recorded. A subset of catheters was inflated to recommended balloon volume and the balloon was needle punctured. RESULTS: Of the 40 latex catheters, 32 (80%) produced a free fragment during spontaneous rupture. Fragments ranged from 2.1 to 3.2 cm with an average size of 2.74 ± 0.33 cm. Latex catheters had average burst volume of 83 mL, 90 mL, 112 mL,120 mL, and 422 mL for 14 Fr, 16 Fr, 18 Fr, 16 Fr 3-way, and 20 Fr 30 cc, respectively. Of the 30 silicone catheters, spontaneous rupture produced no fragments. Average burst volume for silicone catheters was 57 mL, 45 mL, and 55 mL for 14 Fr, 16 Fr, and 18 Fr, respectively. No catheter balloons produced fragments when needle punctures at recommended balloon volumes. CONCLUSION: Latex catheter balloons tolerate higher fill volumes but have a high likelihood of releasing fragments. Silicone catheters burst at lower volumes, but do not release fragments. At normal fill volumes, needle puncture is safe, and cystoscopy is likely unnecessary.

Comparative review of the guidelines for anterior urethral stricture.

PURPOSE: We aimed to provide a detailed comparison between the American Urologic Association (AUA), Société Internationale d'Urologie (SIU), and the European Association of Urology (EAU) guidelines on the evaluation, management, and follow-up of the patients with anterior urethral stricture disease (USD). METHODS: The urethral stricture guidelines from SUI, AUA, and EAU were collected and evaluated regarding the recommendations on diagnosis, evaluation, and treatment of anterior USD. The strength of evidence for each statement was included and discussed when guidelines differed. RESULTS: While the guidelines remarkably align in terms of the diagnostic workup and follow-up, there is discordance in the management of anterior urethral strictures, specifically for the use of endoscopic treatment and stenting. Further, the EAU offers more comprehensive recommendations regarding urethroplasty techniques and patient follow-up. The EAU guidelines are the most recent and first to offer guidance for USD in transgender people and women. CONCLUSION: Reconstructive urology is a rapidly adapting field, and best practices change accordingly. Guideline statements have become more inclusive and expansive but will require further research to improve the level of evidence and continue to provide patients and providers with the best treatment plans.

5-Alpha reductase inhibitor related litigation: A legal database review.

BACKGROUND: 5α-reductase inhibitors are commonly prescribed medications with multiple side effects used in the treatment of male pattern hair loss and benign prostatic hyperplasia. These side effects including "post-finasteride syndrome" may result in lawsuits. OBJECTIVES: To characterize lawsuits involving the adverse side effects of 5α-reductase inhibitor to better understand drivers of litigation and outcomes. METHODS: Legal cases were queried from Nexis Uni using the search terms "5-alpha reductase inhibitor" as well as specific agents "finasteride," "dutasteride" in combination with "malpractice," "negligence," "damage," "loss," "side effect," and "complication." Secondary review was performed with publicly available data on "In Re: Propecia." Relevant cases were reviewed and pertinent characteristics were extracted and summarized using descriptive statistics. RESULTS: Our search yielded 156 unique legal cases in the Nexis Uni database from April 2003 to May 2021. Only 18 of these cases met the inclusion criteria. Adverse events experienced by patients included medication side effects (n = 12, 66.7%), delayed cancer diagnosis (n = 3, 16.7%), and lack of symptom improvement (n = 3, 16.7%). The identity of the plaintiffs were most commonly patients themselves (n = 15, 83.3%). Defendants include pharmaceutical companies (n = 6, 33.3%), a combination of parties (n = 5, 27.8%), and physicians (n = 5, 27.8%) alone. The allegations included sexual side effects such as erectile dysfunction (n = 6, 33.3%) and decreased libido (n = 4, 22.2%). These prescriptions were made for benign prostatic hyperplasia (n = 9, 50%), male pattern hair loss (n = 7, 38.9%), and feminizing hormone therapy (n = 2, 11.1%). Several of these cases involved the same plaintiffs in related cases. No verdicts were against physicians. We noted a largely settled lawsuit involving more than 1000 plaintiffs with limited data on harms alleged and a $4.3 million settled amount. Of the total cases that resulted in a verdict, 9/18 were within the last 3 years. DISCUSSION: The most common complications experienced by patients in our legal review were those involving sexual dysfunction with erectile dysfunction and decreased libido. The growing number of cases in the later years of our review suggests litigation may continue to increase in the coming future. Our review did not identify any individual cases that resulted in a monetary payout beyond a $4.3 million settlement outside of court. CONCLUSION: 5α-reductase inhibitor was alleged to have sexual, mental, and physical side effects, resulting in legal litigation. Despite this, no judgment against a physician or pharmaceutical company was identified. We do note and discuss a large number of lawsuits settled out of court. Given the increase in the number of lawsuits resulting in verdicts over the last 3 years, we suspect that the frequency of litigation around 5α-reductase inhibitors will continue for the foreseeable future.