title: Efficacy and Safety of the Selective α1A-Adrenoceptor Blocker Silodosin for Severe Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: A Prospective, Single-Open-Label, Multicenter Study in Korea.
abstract: OBJECTIVE
  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).
  
  
  METHODS
  A total of 100 subjects from 10 urology centers in Korea were included in this study. The inclusion criteria were as follows: age ≥50 years, International Prostate Symptom Score (IPSS) ≥20, quality of life (QoL) score ≥3, urine volume ≥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.
authors.affiliation: Department of Urology, Yeungnam University Hospital, Daegu, Korea.
authors.forename: Ki Hak
authors.initials: KH
authors.lastname: Moon
authors.affiliation: Department of Urology, Yeungnam University Hospital, Daegu, Korea.
authors.forename: Phil Hyun
authors.initials: PH
authors.lastname: Song
authors.affiliation: Department of Urology, Hallym University Medical Center, Seoul, Korea.
authors.forename: Dae Yul
authors.initials: DY
authors.lastname: Yang
authors.affiliation: Department of Urology, Pusan National University Hospital, Busan, Korea.
authors.forename: Nam Cheol
authors.initials: NC
authors.lastname: Park
authors.affiliation: Department of Urology, Seoul National University Hospital, Seoul, Korea.
authors.forename: Soo Woong
authors.initials: SW
authors.lastname: Kim
authors.affiliation: Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Sung Won
authors.initials: SW
authors.lastname: Lee
authors.affiliation: Department of Urology, Seoul St. Mary's Hospital, Seoul, Korea.
authors.forename: Sae Woong
authors.initials: SW
authors.lastname: Kim
authors.affiliation: Department of Urology, Korea University Guro Hospital, Seoul, Korea.
authors.forename: Du Geon
authors.initials: du G
authors.lastname: Moon
authors.affiliation: Department of Urology, Chonbuk National University Medical School, Institute for Medical Sciences, Chonbuk National University and Biomedical Research Institute and Clinical Trial Center of Medical Device of Chonbuk National University Hospital, Jeonju, Korea.
authors.forename: Jong Kwan
authors.initials: JK
authors.lastname: Park
authors.affiliation: Department of Urology, Asan Medical Center, Seoul, Korea.
authors.forename: Tai Young
authors.initials: TY
authors.lastname: Ahn
authors.affiliation: Department of Urology, Chonnam National University Medical School, Gwangju, Korea.
authors.forename: Kwangsung
authors.initials: K
authors.lastname: Park
keywords: Benign prostatic hyperplasia; Lower urinary tract symptoms; Selective; Silodosin; α1A-Adrenoceptor antagonis