Efficacy and Safety of the Selective alpha1A-Adrenoceptor Blocker Silodosin for Severe Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: A Prospective, Single-Open-Label, Multicenter Study in Korea

ABSTRACT

PURPOSE: To evaluate the efficacy and safety of silodosin 8 mg once daily in a 12-week treatment of subjects with severe lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: A total of 100 subjects from 10 urology centers in Korea were included in this study. The inclusion criteria were as follows age > or =50 years, International Prostate Symptom Score (IPSS) > or =20, quality of life (QoL) score > or =3, urine volume > or =120 mL and maximal urinary flow rate (Qmax) <15 mL/s, and postvoid residual volume (PVR) <100 mL. We assessed the improvement of LUTS with change in IPSS, QoL score, Qmax, PVR, and adverse events at baseline and 4 and 12 weeks after treatment with silodosin 8 mg once daily. RESULTS: The IPSS values were 23.27+/-3.34, 15.89+/-6.26, and 13.80+/-6.31 at baseline, 4, and 12 weeks, respectively, with significant improvements (p<0.0001, p=0.0214, respectively). QoL scores were 4.44+/-0.85, 3.38+/-1.20, and 3.04+/-1.20 at baseline, 4, and 12 weeks, respectively, and the differences were statistically significant (p<0.0001). There was a significant difference in Qmax between baseline and 12 weeks (p<0.0001) but not in PVR (p=0.9404) during the clinical trial. The most frequent adverse event in this study was ejaculation failure with 13 cases. However, no subject dropped out because of ejaculation failure, and in 12 of the 13 cases it was fully resolved without further treatment. CONCLUSIONS: Silodosin 8 mg once daily may be effective and safe in Korean patients with severe LUTS associated with BPH.