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Comparative efficacy and safety of silodosin and tadalafil combination or monotherapy for treating lower urinary tract symptoms due to benign prostatic obstruction: A systematic review and meta-analysis

Abdul Azis, Syarifuddin Syarif, Moh. Anfasa Giffari Makkaraka, A. T. F. Zainal, S. Rahmat, M. Fakhri

Central European Journal of Urology, 2025

Abstract

Introduction: Over the last few years, trends in managing benign prostatic hyperplasia (BPH) have improved, advancing from reliance on surgery to satisfactory medical therapies. However, the efficacy and safety of combination therapies, including silodosin and tadalafil, are not well established compared to monotherapy for treating lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO).

Material and methods: A systematic search was conducted in PubMed, ScienceDirect, Cochrane Library, and Scopus up to April 1, 2024. The quality of the studies was assessed using The Cochrane Risk of Bias (RoB) Tools 2 and Risk of Bias in Non-randomized Studies of Exposures (ROBINS-E). Meta-analysis was conducted using RevMan 5.4.

Results: A total of 1,300 records were screened, resulting in 7 final studies. Our meta-analyses showed that international prostate symptom score (IPSS), maximum urine flow rate (Qmax), and post-void residual volume (PVR) led to considerably greater improvements with the combination of silodosin and tadalafil compared to using either as monotherapy. However, combination therapy notably exhibited higher rates of adverse events (AE). On the other hand, as monotherapy, silodosin demonstrated a statistically significant improvement in Qmax (p = 0.006) and PVR (p = 0.02) over tadalafil but with higher rates of total AE, discontinuation, and risk of retrograde ejaculation.

Conclusions: Silodosin and tadalafil are effective for treating LUTS in men…

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