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

Abstract

ObjectiveTo 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 methodsIn all, 150men with untreated LUTS/BPH with or without ED were randomised to receive sildenafil 25mg once daily (OD) or placebo OD (night time) combined with tamsulosin 0.4mg OD (day time) for 6months. Changes from pre-treatment scores in International Prostate Symptom Score (IPSS), IPSS-quality of life (QoL) score, maximum urinary flow rate (Qmax), and the five-item version of the International Index of Erectile Function questionnaire (IIEF-5) were assessed at 3 and 6months. Safety profiles were assessed by physical examination and monitoring clinical adverse events. ResultsGroup A comprised of men who received tamsulosin and sildenafil (75men), 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 3months and −37% vs −19.6% (P=0.043) at 6months after treatment. Qmax 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 3months and 62.4% vs 12.4% at 6months after treatment (both P<0.001). ConclusionSildenafil 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.