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

Ki Hak Moon, Phil Hyun Song, Dae Yul Yang, Nam Cheol Park, Soo Woong Kim, Sung Won Lee, Sae Woong Kim, Du Geon Moon, Jong Kwan Park, Tai Young Ahn, Kwangsung Park

Research output: Contribution to journalArticle

2 Citations (Scopus)

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 ≥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.

Original languageEnglish
Pages (from-to)335-340
Number of pages6
JournalKorean Journal of Urology
Volume55
Issue number5
DOIs
Publication statusPublished - 2014 Jan 1

Fingerprint

Lower Urinary Tract Symptoms
Residual Volume
Prostatic Hyperplasia
Korea
Adrenergic Receptors
Multicenter Studies
Prostate
Ejaculation
Quality of Life
Safety
Urology
Clinical Trials
Urine
Therapeutics
silodosin

Keywords

  • Benign prostatic hyperplasia
  • Lower urinary tract symptoms
  • Selective
  • Silodosin

ASJC Scopus subject areas

  • Urology

Cite this

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. / Moon, Ki Hak; Song, Phil Hyun; Yang, Dae Yul; Park, Nam Cheol; Kim, Soo Woong; Lee, Sung Won; Kim, Sae Woong; Moon, Du Geon; Park, Jong Kwan; Ahn, Tai Young; Park, Kwangsung.

In: Korean Journal of Urology, Vol. 55, No. 5, 01.01.2014, p. 335-340.

Research output: Contribution to journalArticle

Moon, Ki Hak ; Song, Phil Hyun ; Yang, Dae Yul ; Park, Nam Cheol ; Kim, Soo Woong ; Lee, Sung Won ; Kim, Sae Woong ; Moon, Du Geon ; Park, Jong Kwan ; Ahn, Tai Young ; Park, Kwangsung. / 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. In: Korean Journal of Urology. 2014 ; Vol. 55, No. 5. pp. 335-340.
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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 ≥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.",
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AU - Song, Phil Hyun

AU - Yang, Dae Yul

AU - Park, Nam Cheol

AU - Kim, Soo Woong

AU - Lee, Sung Won

AU - Kim, Sae Woong

AU - Moon, Du Geon

AU - Park, Jong Kwan

AU - Ahn, Tai Young

AU - Park, Kwangsung

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N2 - 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 ≥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.

AB - 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 ≥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.

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