Comparative review of the guidelines for anterior urethral stricture.

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BackgroundDespite their efficacy and general safety, rare but devastating adverse drug reactions have been associated with phosphodiesterase type 5 inhibitors.ObjectivesTo determine the safety profile of oral phosphodiesterase type 5 inhibitors with a particular focus on priapism and malignant melanoma.Materials and methodsIn 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.ResultsA 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.ConclusionPhosphodiesterase 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.

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. ResultsWe 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. ConclusionThe 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.

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.

This manuscript has not been published and is not under consideration for publication elsewhere.

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.

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