The Effectiveness and Safety of Silodosin and Doxazosin in the Treatment of Benign Prostatic Hyperplasia: A Randomized Controlled Trial

Background: Benign prostatic hyperplasia (BPH) commonly causes lower urinary tract symptoms (LUTS) in older men.Alpha-1 blockers like silodosin and doxazosin XL are effective medical therapies but have not been directly compared.The objective of this study is to compare the efficacy and safety of silodosin versus doxazosin XL for LUTS treatment inBPH patients.Patients and Methods: We conducted a prospective, randomized, parallel-group trial in the outpatient urology clinicat a university hospital in Egypt. Two hundred men aged greater than or equal to 40 years with moderate LUTS (IPSS≥8) secondary to BPH were included in our trial. Patients were randomly allocated to daily silodosin 8 mg (n=100) ordoxazosin XL 4 mg (n=100) for 1 month. We measured changes in international prostate symptom score (IPSS), Qmax,postvoid residual, quality of life scores, and incidence of side effects.Results: A total of 200 patients were enrolled in this study. Silodosin resulted in significantly greater improvement inIPSS (11.67 vs. 15.48 points, P<0.001), Qmax (21.79 vs. 15.28 ml/s, P<0.001), Postvoid residual (73.35 vs. 100.13 mL,P<0.001), and QoL score (2.32 vs. 3.55, P<0.001) than doxazosin XL. Silodosin had more retrograde ejaculation (34 vs.7%, P<0.001) but less hypotension (6 vs. 17%, P=0.015).Conclusions: In BPH patients with moderate LUTS, silodosin improved symptoms and flow measures more thandoxazosin XL and had a favorable tolerability profile, but higher sexual side effects. Silodosin may be preferred overdoxazosin XL for the selective alpha blockade.