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

Document Type : Original Article

Authors

Department of Urology, Faculty of Medicine, Helwan University. Cairo, Egypt.

Abstract

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 in
BPH patients.
Patients and Methods: We conducted a prospective, randomized, parallel-group trial in the outpatient urology clinic
at 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) or
doxazosin 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 in
IPSS (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 than
doxazosin XL and had a favorable tolerability profile, but higher sexual side effects. Silodosin may be preferred over
doxazosin XL for the selective alpha blockade.

Keywords

The Egyptian Journal of Surgery
Volume 44, Issue 2
April 2025
Pages 615-622

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