A prospective randomised placebo-controlled study of the impact of dutasteride/tamsulosin combination therapy on sexual function domains in sexually active men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH)

To prospectively assess the impact of the fixed-dose combination of the 5-alpha reductase inhibitor (5ARI), dutasteride 0.5 mg and the alpha-1 blocker, tamsulosin 0.4 mg (DUT-TAM FDC) therapy on sexual function domain scores in sexually active males with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), using the Men's Sexual Health Questionnaire (MSHQ).

This European and Australian double-blind, placebo-controlled, parallel-group study was conducted at 51 centres.

age ≥50 years, International Prostate Symptom Score ≥12, prostate volume ≥30 cc, prostate-specific antigen 1.5-10 ng/mL. Patients were randomised 1:1 to DUT-TAM FDC therapy or placebo for 12 months. The change from baseline to Month 12 on the total MSHQ (primary endpoint) and MSHQ erection, ejaculation and satisfaction domains (secondary outcome) was assessed, using a mixed model repeated measures analysis. Safety was evaluated.

The intention-to-treat population included 489 patients (243 DUT-TAM FDC therapy; 246 placebo). A significant decrease (worsening) was observed with DUT-TAM FDC therapy versus placebo on the total MSHQ score (-8.7 vs -0.7; standard error [SE]: 0.81, 0.78; P <0.001), and the ejaculation (-7.5 vs -0.6; SE: 0.56, 0.55; P<0.001) and satisfaction (-0.6 vs +0.3; SE: 0.3, 0.29, P =0.047) domains, but not the erection domain (-1.0 vs -0.5; SE: 0.19, 0.19, P=0.091). The proportion of patients with any adverse event (AE) was higher with DUT-TAM FDC therapy (57%) than placebo (47%).

This is the first domain-specific quantitative evaluation of DUT-TAM FDC therapy on sexual function in males with LUTS secondary to BPH. The observed changes in the MSHQ with DUT-TAM FDC therapy were driven by changes in the ejaculation domain. These findings will help give context to erectile and ejaculatory dysfunction AEs reported spontaneously in earlier 5ARI studies. This article is protected by copyright. All rights reserved.

BJU international. 2017 Oct 16 [Epub ahead of print]

Claus G Roehrborn, Michael J Manyak, Juan Manuel Palacios-Moreno, Timothy H Wilson, Erik Pm Roos, Javier Cambronero Santos, Dimitrios Karanastasis, Janet Plastino, Francois Giuliano, Raymond C Rosen

Department of Urology, UT Southwestern Medical Center, Dallas, TX, USA., GSK, Washington, DC, USA., GSK, Madrid, Spain., PAREXEL International, Durham, NC, USA., Antonius Ziekenhuis Sneek, Sneek, the Netherlands., Hospital Universitario Infanta Leonor, Madrid, Spain., Urologic Clinic, General Hospital of Athens "Elpis", Athens, Greece., GSK, Collegeville, PA, USA., Neuro-Urology R. Poincare Hospital AP-HP, Garches, UMR1179 Inserm-UVSQ-Paris Saclay University, ParisFrance., New England Research Institutes, Watertown, MA, USA.

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