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, 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 (Qmax), 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.ResultsGroup 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. 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 3 months and 62.4% vs 12.4% at 6 months 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.

Placebo Responses Among Men With Erectile Dysfunction Enrolled in Phosphodiesterase 5 Inhibitor Trials

“…Eardly et al, 23 2004 Egerdie et al, 24 2012 Evilyaoglu et al, 25 Farca et al, 26 2008 Fawzi et al, 27 Gacci et al, 28 Miner et al, 47 2008 Moncada et al, 48 2009 Moon et al, 49 2015 Nunes et al, 50 2013 Nurnberg et al, 51 2003 Orr et al, 52 2006 Ortaç et al, 53 2013 Paick et al, 54 2008 Paick et al, 55 2008 Paick et al, 56 2010 Park et al, 57 2010 Park et al, 58 2010 Park et al, 59 2015…”

The Adverse Effects of Tamsulosin in Men with Benign Prostatic Hyperplasia, a Review of the Literature

“…Concurrently, there is a correlation between patients with ejaculatory disorders after the use of α-blockers, whose explanation is that blockade of α-adrenergic receptors in the urinary tract causes relaxation of the smooth muscle of the epididymis, seminal ducts, and vas deferens, which can lose the power of contraction and, therefore, of semen ejection. The ejaculatory disorder resulting from tamsulosin is characterized as retrograde ejaculation [33,[42][43][44][45][46][47][48][49][50][51].…”

Defining the Efficacy and Safety of Phosphodiesterase Type 5 Inhibitors with Tamsulosin for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia with or without Erectile Dysfunction: A Network Meta-Analysis

“…Among the 7 studies, six trials were used to compare the relative IPSS's improving efficacy of different kinds of PDE5-Is with tamsulosin for the treatment of BPH-LUTS with or without ED [6,[9][10][11][12][13]; six trials were used to compare the relative Q max 's improving efficacy [6,[10][11][12][13][14]; four trials were used to compare the relative IIEF's improving efficacy [6,10,11,13], and six trials were used to compare the relative Table 1: 25-item CONSORT checklist. Study 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Total score…”

“…✓: fulfilled the item, ×: did not fulfill the item. BioMed Research International safety [6,[9][10][11][12][13] (Figure 1). The ranking of probability of different interventions was estimated by comparing the SUCRA shown in Table 3.…”