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

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

doi:10.1016/j.aju.2016.11.001

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

Authors

Amr Fawzi¹, Mostafa Kamel¹, Emad Salem¹, Esam Desoky¹, Mohamed Omran¹, Hazem Elgalaly¹, Ahmed Sakr¹, Aref Maarouf¹, Salem Khalil¹

Affiliation

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

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 (Q_max), and the five-item version of the International Index of Erectile Function questionnaire (IIEF-5) were assessed at 3 and 6 months. Safety profiles were assessed by physical examination and monitoring clinical adverse events.

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% (P = 0.039) at 3 months and -37% vs -19.6% (P = 0.043) at 6 months after treatment. Q_max significantly improved in both groups compared with before treatment (P < 0.001). The IIEF-5 scores improved more in Group A than in Group B, at 58.7% vs 11.7% at 3 months and 62.4% vs 12.4% at 6 months after treatment (both P < 0.001).

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.