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Arab J Urol. 2016 Dec 29;15(1):53-59. doi: 10.1016/j.aju.2016.11.001. eCollection 2017 Mar.

Sildenafil citrate in combination with tamsulosin versus tamsulosin monotherapy for management of male lower urinary tract symptoms due to benign prostatic hyperplasia: A randomised, double-blind, placebo-controlled trial.

Arab journal of urology

Amr Fawzi, Mostafa Kamel, Emad Salem, Esam Desoky, Mohamed Omran, Hazem Elgalaly, Ahmed Sakr, Aref Maarouf, Salem Khalil

Affiliations

  1. Department of Urology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.

PMID: 28275519 PMCID: PMC5329701 DOI: 10.1016/j.aju.2016.11.001

Abstract

OBJECTIVE: To assess the additive effect of sildenafil citrate to tamsulosin in the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia (LUTS/BPH) in men with or without erectile dysfunction (ED).

PATIENTS AND METHODS: In all, 150 men with untreated LUTS/BPH with or without ED were randomised to receive sildenafil 25 mg once daily (OD) or placebo OD (night time) combined with tamsulosin 0.4 mg OD (day time) for 6 months. Changes from pre-treatment scores in International Prostate Symptom Score (IPSS), IPSS-quality of life (QoL) score, maximum urinary flow rate (

RESULTS: Group A comprised of men who received tamsulosin and sildenafil (75 men), whilst those in Group B received tamsulosin and placebo (75). The IPSS was significantly improved in Group A compared to Group B, at -29.3% vs -13.7% (

CONCLUSION: Sildenafil citrate combined with tamsulosin improved LUTS, erectile function, and patient QoL more than tamsulosin monotherapy with the merit of a comparable safety profile in patients with LUTS/BPH.

Keywords: BMI, body mass index; Benign prostatic hyperplasia (BPH); CONSORT, Consolidated Standards of Reporting Trials; ED, erectile dysfunction; IIEF-5, five-item version of the International Index of Erectile Function questionnaire; Lower urinary tract symptoms (LUTS); NO, nitric oxide; OD, once daily; PDE5-I, phosphodiesterase type 5 inhibitor; Qmax, maximum urinary flow rate; QoL, quality of life; RCT, randomised controlled trial; SMD, standardised mean difference; Sildenafil; Tamsulosin

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