Medications Mostly Associated With Ejaculatory Disorders: Assessment of the Eudra-Vigilance and Food and Drug Administration Pharmacovigilance Databases Entries.

OBJECTIVE: To identify which medications are mostly associated with ejaculatory disorders through a disproportionality analysis. METHODS: The Food and Drug Administration Adverse Event Reporting System (FDA-FAERS) and the Eudra-Vigilance (EV) database were queried to identify medications more commonly associated to ejaculatory disorders from September 10, 2012 to June 1, 2023. Proportional Reported Ratios (PRRs) were computed for all the selected drugs. RESULTS: Overall, 7404 reports of ejaculatory disorders reports were identified, and of these, 6854 cases (92.6%) were attributed to ten specific medications. On FDA-FAERS and EV databases, Paroxetine and Tamsulosin were the main responsible of delayed ejaculation (103/448 events, 23.0%) and retrograde ejaculation (366/1033 events, 35.4%), respectively. Finasteride was mostly related to painful ejaculation and ejaculation failure, with 150 events (7.8%) and 735 events (38.4%) respectively. Within the group of high-risk medications, Sildenafil presented higher risk of ejaculatory disorders than Tadalafil (PRR=5.85 (95%CI 5.09-6.78), P < .01). CONCLUSION: Ten drugs were recognized to display significant reporting levels of ejaculatory disorders. Among them, Finasteride and Sildenafil were responsible for the most reports in FDA-FAERS and in EV databases, respectively. Physicians should thoroughly counsel patients treated with these drugs about the risk of ejaculatory disorders. Further integration into clinical trials is needed to enhance the applicability and significance of these results.

Prospective Cross-Sectional Evaluation of Penile Helicine Circulation by Power Doppler During Dynamic Ultrasound in Veno-Occlusive Erectile Dysfunction.

OBJECTIVE: To evaluate the usefulness of Power Doppler to improve the diagnostic work up of veno-occlusive erectile dysfunction patients. MATERIALS AND METHODS: Patients affected by erectile dysfunction, mean IIEF 5 = 13.5 (12-17) for at least 6 months, were enrolled in a prospective cross-sectional study. All patients underwent Dynamic Power Doppler after intracavernous injection of vasoactive drugs (PGE1 20 mcg and Papaverine 6 mg). Poor responders' patients subsequently underwent to cavernosometry to get a full assessment of the vascular framework. RESULTS: 202 patients (mean age 46 years), were included in the study. 96 subjects (47.5%) who did not adequately respond to the intracavernous injection -test, subsequently underwent to cavernosometry. In 42 of 96 patients (43.7%) cavernosometry was positive for veno-occlusive dysfunction. In a total of 160 patients who did not have veno-occlusive dysfunction (54 with negative cavernosometry + 106 intracavernous injection-test responders), the Power Doppler was normal in 126 (78.8%) and pathological in 34 (21.3%) in terms of steric conformation of "low flow" vessels corresponding to the Cavernosal Terminal Unit. The diagnostic sensitivity of Power Doppler towards veno-occlusive dysfunction was found to be 52.4% (Positive Predictive Value: 39.3%), the specificity was 78.8% (Negative Predictive Value: 86.3%) and the total diagnostic accuracy was equal to 73.3%. CONCLUSION: Collected data evidenced that patients who reported altered morphological features of the Cavernosal Terminal Unit had an approximately 4-fold greater risk of having veno-occlusive dysfunction compared to patients who had normal Power Doppler features (OR = 4.076; 95% CI: 1.996-8.327).

Assessing the Impact of the Absence of Detrusor Muscle in Ta Low-grade Urothelial Carcinoma of the Bladder on Recurrence-free Survival.

BACKGROUND: Obtaining detrusor muscle (DM) in transurethral resection of bladder tumor (TURBt) specimen is considered a surrogate marker of resection quality. However, evidence was principally investigated in high-risk tumors. Therefore, DM sampling for low-grade (LG) urothelial carcinoma (UC) remains poorly investigated and certainly requires further investigation. OBJECTIVE: To assess whether the absence of DM in TURBt specimen has a negative impact on recurrence-free survival (RFS) in patients with a Ta LG UC. DESIGN, SETTING, AND PARTICIPANTS: A multicenter TURBt database was queried for "LG, Ta, UC of the bladder." All patients treated between 1996 and 2018 with tumor grade assessed according to both 1973 World Health Organization and 2004 WHO/International Society of Urological Pathology grading classifications and with a minimum follow-up of 1 yr were included. Patients with a previous history of high-grade UC, upper urinary tract UC, or bladder tumor differentiations other than UC were excluded. INTERVENTION: TURBt. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Baseline demographic, clinical, and pathologic data were analyzed. The European Organization for Research and Treatment of Cancer (EORTC) risk group was recorded. Kaplan-Meier analysis was performed to assess the predictive role of clinical and pathologic data for RFS. Univariable and multivariable Cox regression analyses were performed to identify the predictors of recurrence. RESULTS AND LIMITATIONS: Overall, 521 patients were included. At Kaplan-Meier analysis, the low-risk cohort displayed significantly higher RFS than the intermediate-risk cohort (1-yr RFS 87% vs 79%; log-rank p = 0.007). At univariable Cox regression analysis, only gender, multiple tumors, tumor diameter ≥3 cm, and EORTC risk group were significant predictors of recurrence. Absence of DM had no impact on RFS. Multivariable Cox regression analysis confirmed gender and EORTC risk group as independent predictors of recurrence. CONCLUSIONS: Absence of DM in TURBt specimen has negligible role in RFS of patients with Ta LG tumors of the bladder. PATIENT SUMMARY: In this study, we assessed the role that detrusor muscle (DM) in transurethral resection of bladder tumor specimen has in recurrence-free survival, in patients with a Ta low-grade urothelial carcinoma of the bladder. Absence of DM has no impact on tumor recurrence; therefore, it does not require additional attention.

Prospective randomized study comparing monopolar with bipolar transurethral resection of prostate in benign prostatic obstruction: 36-month outcomes.

OBJECTIVES: Monopolar transurethral resection of the prostate (TURP) is the gold standard surgical treatment for bothersome moderate to severe lower urinary tract symptoms (LUTS) secondary to benign prostate obstruction. The aim of the study is to compare monopolar versus bipolar TURP focusing on operative and functional outcomes, and evaluating complications with a long-term follow-up. METHODS: From January 2007 to July 2014, a total of 497 patients were randomized and prospectively scheduled to undergo bipolar (251) or monopolar (246) TURP. International prostate symptom score (IPSS), IPSS-Quality of life (QoL), post-void residual and maximum flow rate were assessed preoperatively and postoperatively at 3, 12, 24 and 36 months. Operative time, length of catheterization and hospitalization were all recorded. Complications were classified and reported. RESULTS: All patients completed the 36-month follow-up visit. Perioperative results showed no statistical significance between the two groups in terms of catheterization days, post-void residual, IPSS, IPSS-QoL score. The hospitalization length was found statistically significant in favor of the bipolar group. The 3-, 12-, 24- and 36-month follow-up showed significant and equal improvements in LUTS related to BPO in the two treatment groups. Regarding TURP complications, significant differences were observed in relation to urethral strictures, blood transfusion and TUR syndrome in favor of the bipolar group. CONCLUSIONS: Monopolar and bipolar TURP are safe and effective techniques for BPH management. Bipolar TURP in our prospective study reported the same efficacy of monopolar prostate resection, with a significant reduction of related complications.