Sexual Function in Men with Lower Urinary Tract Symptoms and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia: Results of a 6-Month, Randomized, Double-Blind, Placebo-Controlled Study of Tadalafil Coadministered with Finasteride

Sidney Glina, Claus Roehrborn, Adil Esen, Alexey Plekhanov, Sebastian Sorsaburu, Carsten Henneges, Hartwig Büttner, Lars Viktrup

Research output: Contribution to journalArticle

35 Scopus citations

Abstract

Introduction: Tadalafil (TAD) 5mg coadministered with finasteride (FIN) 5mg significantly improves lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH) and prostatic enlargement. However, its effects on erectile/sexual function have yet to be fully described. Aim: Assess the effects of TAD/FIN coadministration (compared with placebo [PBO]/FIN) on erectile and sexual function in sexually active men with LUTS and prostatic enlargement secondary to BPH with or without baseline comorbid erectile dysfunction (ED). Methods: A randomized, double-blind, PBO-controlled study of 695 men (610 sexually active; 450 with baseline ED; 404 sexually active with baseline ED) conducted at 70 sites in 13 countries. TAD 5mg or PBO once daily coadministered with FIN 5mg once daily for 26 weeks. Main Outcome Measures: International Index of Erectile Function (IIEF) domain and single-item scores; proportions of patients who demonstrated minimal clinically important differences (MCIDs) in IIEF-Erectile Function domain scores (IIEF-EF; MCID defined as ≥4-point improvement); and sexual dysfunction adverse events (AEs). Results: Compared with PBO/FIN, TAD/FIN resulted in improvements for all IIEF domain and single-item scores assessed among patients with baseline ED (P≤0.002 for all measures) and among patients without baseline ED (P≤0.041 for all measures). Compared with PBO/FIN, significantly larger percentages of sexually active men with baseline ED treated with TAD/FIN achieved an IIEF-EF MCID after 4, 12, and 26 weeks of therapy (P<0.001 for odds ratio comparisons between TAD/FIN and PBO/FIN at all 3three postbaseline timepoints). The incidence of sexual AEs was low: five TAD/FIN patients and seven PBO/FIN patients reported sexual AEs, including ED, decreased/lost libido, and ejaculation disorders. Conclusions: TAD/FIN coadministration for the treatment of men with LUTS and prostatic enlargement secondary to BPH concurrently leads to statistically significant improvements in erectile/sexual function and is well-tolerated, regardless of the presence/absence of ED at treatment initiation.

Original languageEnglish (US)
Pages (from-to)129-138
Number of pages10
JournalJournal of Sexual Medicine
Volume12
Issue number1
DOIs
StatePublished - Jan 1 2015

Keywords

  • 5-Alpha Reductase Inhibitors
  • Benign Prostatic Hyperplasia
  • Ejaculatory Function
  • Erectile Dysfunction
  • Finasteride
  • Lower Urinary Tract Symptoms
  • Orgasmic Function
  • Phosphodiesterase Type 5 Inhibitors
  • Tadalafil

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology
  • Urology

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