Background: Recently several clinical trials have focused on the efficacy and safety of silodosin, a new, highly selective α1A-blocker. We tried to verify silodosin's superiority to placebo and non-inferiority to tamsulosin in treating patients with lower urinary tract symptoms (LUTS) associated with BPH.
Methods: All randomized placebo- and active- controlled trials with silodosin were included systematically using Medline, Embase and The Cochrane Library. Primary outcome was International Prostate Symptom Score (IPSS) and IPSS subsores; secondary outcomes were peak urinary flow rate (Q(max)), quality of life (QoL) and primary adverse events (AEs) included retrograde ejaculation, dizziness and headache.
Results: The data of the included randomized controlled trials (RCTs) were collected, extracted, and assessed by our protocol. Five RCTs including a total of 2595 patients were identified. Meta-analysis indicated that silodosin achieved significant improvement versus placebo in total IPSS, in IPSS subscores, and in Q(max); silodosin showed a greater improvement in voiding symptoms than tamsulosin, and a higher incidence of retrograde ejaculation than placebo and tamsulosin. No significant differences were observed in total IPSS, in IPSS storage symptoms, in Q(max) and in QoL when compared with tamsulosin. Silodosin was associated with the same low incidence of dizziness and headache with placebo and tamsulosin.
Conclusions: Silodosin is an effective and well-tolerated treatment for both voiding and storage symptoms in patients with LUTS associated with BPH. Despite with increased retrograde ejaculation, its overall efficacy is not inferior to tamsulosin, while at the same time being possibly superior to tamsulosin.