Efficacy and Safety of the Selective α_1A-Adrenoceptor Blocker Silodosin for Severe Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: A Prospective, Single-Open-Label, Multicenter Study in Korea

Abstract

PurposeTo 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 MethodsA 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.ResultsThe 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.ConclusionsSilodosin 8 mg once daily may be effective and safe in Korean patients with severe LUTS associated with BPH.

Comparing the effect of Alpha blocker (Silodosin) and Phosphodiesterase type 5 inhibitor (Tadalafil) in benign prostate hyperplasia patients with lower urinary tract symptoms: a single centre study

“…But this finding is contraindicated in the study by Moon KH (mean 31.3, 31.7; p 0.9404). 19 In the present study, we found that there is definitive improvement in IPSS (mean 16.46±6.34, 10.66±3.84) (p=0.000) in PDE5I group alone. This is supported by the study conducted by Lee SW et al where SD was -5.97 and p value was <0.05.…”

“…Moon KH et al in their study had shown similar results, where mean (11.2, 14.7) p<0.0001. 19 In the present study, there was significant improvement in PVR (mean 64.33±40.95, 33.52±18.94 (p = 0.001) with alpha blockers alone. But this finding is contraindicated in the study by Moon KH (mean 31.3, 31.7; p 0.9404).…”

A Study on Efficacy and Safety of Silodosin in Geriatric Patients with Benign Prostatic Hyperplasia

“…Therefore, the blockage of α1A adrenoreceptors results in prostatic and urethral smooth muscle relaxation and may improve the voiding symptoms. Yokoyama et al [18]demonstrated that the selective α1A-blocker silodosin exerts inhibitory effects on detrusor overactivity by modulating C-fibre afferent activity using animal models. Consequently, α1A-blockade can improve the storage symptoms.…”

Evolving Role of Silodosin for the Treatment of Urological Disorders – A Narrative Review

“…Thus, silodosin proved to be effective and safe. 64 Nocturia in BPH/LUTS Among patients with BPH, approximately 85% experience two or more episodes per night. Several studies have shown the efficacy of silodosin in reducing nocturia.…”