Fragility index of urological literature regarding medical expulsive treatment.

INTRODUCTION: The role of medical expulsive treatment (MET) is controversial. Fragility index is an additional metric to assess randomized controlled trials (RCTs) outcome validity and indicates how many patients would be required to convert a trial from being statistically significant, to not significant. The larger is the FI, the better the trial's data. The aim of this study is to assess FI of RCTs regarding MET for ureteral stones. MATERIALS AND METHODS: A systematic literature search was performed. RCTs, reporting stone expulsion as a dichotomous outcome, showing statistical significance were eligible. FI (the number of patients needed to change from a non-event to event group, to lose statistical significance) and Fragility quotient (FI divided by total sample size), were calculated while Pearson's correlation and Mann-Whitney U test were used as appropriate. RESULTS: Thirty-six RCTs were eligible, with median FI = 3.5 and fragility quotient = 0.042, median sample size = 81, median journal impact factor = 1.73 and median reported p value = 0.008. In 33.3% of the studies, number of patients lost during follow-up was larger than FI, while in 13.89% of the studies, FI was 0, indicating use of inappropriate statistical method. Pearson's correlation showed significant positive association between FI and sample size (r = 0.981), number of events (r = 0.982) and impact factor (r = 0.731), while no association was found with p value or publication year. CONCLUSIONS: In this analysis, a calculated FI of 3.5 indicates that findings from RCTs on MET for ureteral stones are fragile and should be interpreted in combination with clinical thinking and expertise.

A-blockers for the management of lower urinary tract symptoms in patients with prostate cancer treated with external beam radiotherapy: a randomized controlled study.

BACKGROUND: This is a prospective study aiming to assess the efficacy of α-blockers in treating radiotherapy-induced symptoms of the lower urinary tract and its possible prophylactic role on acute urinary retention (AUR) in patients undergoing radical external beam radiotherapy (EBRT) for localized prostate cancer (PCa). METHODS: Overall, 108 patients with localized PCa were recruited and randomly assigned in to two groups; 54 patients of Group 1 received tamsulosin 0.4 mg once daily with the initiation of EBRT and for 6 months and 54 patients of Group 2 served as the control group. All patients received radical EBRT and had post-void volume (Vres) assessment. The International Prostate Symptom Score (IPSS) questionnaire and evaluation of episodes of AUR were performed after the end of radiotherapy, at 3 and at 6 months. RESULTS: The incidence of AUR was significantly (p = 0.027) lower in group 1 compared to group 2. No independent predictive factors for AUR were identified in regression analysis. The IPSS changes in univariate and multivariate analysis at 3 months showed significant correlation with α-blockers only, while at 6 months showed significant correlation with Vres assessments (at 3 and 6 months) and with α-blockers. Side effects due to medication were mild and none of the patients discontinued the treatment. CONCLUSIONS: The selective use of α-blocker appears to prevent AUR in EBRT-treated patients. Although the administration of α-blockers might relieve patient-reported symptoms, there are no established independent predictive factors to distinguish patients who may benefit.