Silodosin in treating men with BPH-associated lower urinary tract symptoms: a systematic review and network meta-analysis

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OBJECTIVES: To compare the efficacy and safety of silodosin-a highly selective α₁A-adrenoceptor antagonist-with placebo, tamsulosin, naftopidil, and alfuzosin in men with benign prostatic hyperplasia (BPH)-related lower urinary tract symptoms (LUTS). METHODS: We conducted a systematic review and network meta-analysis (NMA) of randomized controlled trials retrieved from EMBASE, PubMed, Cochrane Library, ScienceDirect, and Web of Science until February 2024. Studies were selected based on predefined PICOS criteria. Two reviewers independently extracted data and assessed risk of bias using the Cochrane RoB tool. A frequentist random-effects NMA was performed; heterogeneity was evaluated with I 2 statistic, and publication bias was assessed using Egger's and Begg's tests. Treatment rankings were based on surface under the cumulative ranking (SUCRA) probabilities. RESULTS: Twenty-five RCTs (n = 6,831) were included. NMA showed silodosin significantly improved voiding symptoms versus tamsulosin (MD = 0.52, 95% CI: 0.01-0.56) and total IPSS versus naftopidil (P < 0.001). Silodosin monotherapy ranked highest for symptom improvement (SUCRA: 93.3-97.5%). However, it was associated with higher overall adverse events versus tamsulosin (RR = 1.26, P < 0.001) and significantly increased risk of retrograde ejaculation versus placebo (RR = 24.94, P < 0.001). Combination therapy with tadalafil improved urinary flow (SUCRA = 56.7%). CONCLUSION: Silodosin is highly effective for BPH-LUTS, particularly for voiding symptoms, but carries a elevated risk of ejaculatory dysfunction. Combination with tadalafil may enhance urinary flow. Clinicians should weigh efficacy against adverse events; further trials are needed to confirm long-term benefits.