Efficacy and Safety of Silodosin for the Treatment of Female LUTS: A 12‐Week Prospective, Single‐Center Study

ABSTRACT Objectives This study aimed to evaluate the clinical efficacy and safety of silodosin in female patients with lower urinary tract symptoms (LUTSs), addressing the limited evidence supporting alpha‐blocker use in this population. Methods A 12‐week, single‐arm, prospective, open‐label study was conducted from May 2021 to January 2023. Female patients aged over 18 with an International Prostate Symptom Score (IPSS) ≥ 8 were enrolled and treated with silodosin (8 mg once daily). Primary endpoints included changes in IPSS from baseline to 12 weeks. Secondary endpoints assessed IPSS quality of life (QOL), Overactive Bladder Symptom Score (OABSS), maximal urinary flow rate (Q max), and residual urine (RU). Results Ninety‐five patients were enrolled, with 85 included in the analysis. After 12 weeks, the mean total IPSS significantly decreased from 18.65 ± 6.89 at baseline to 12.54 ± 5.28 ( p < 0.001). IPSS‐QOL improved from 4.14 ± 1.01 to 3.12 ± 0.79 ( p < 0.001). OABSS decreased from 6.89 ± 3.41 to 4.28 ± 2.39 ( p < 0.001), and RU reduced from 51.39 ± 55.38 to 29.95 ± 29.83 mL ( p < 0.001). Q max increased from 13.96 ± 6.74 to 16.48 ± 6.09 mL/s ( p < 0.001), while voiding volume increased from 163.02 ± 70.53 to 176.12 ± 47.16 mL ( p = 0.026). Silodosin was well tolerated, with no serious adverse events noted. Conclusions Silodosin demonstrates efficacy and safety in treating female patients with moderate‐to‐severe LUTS, suggesting that it can be considered a viable treatment option alongside established therapies. Further studies are warranted to confirm these findings.