title: Changes in peak urinary flow and voiding efficiency in men with signs and symptoms of benign prostatic hyperplasia during once daily tadalafil treatment.
abstract: OBJECTIVE
  To determine, by post hoc analysis, the effects of tadalafil (a long-acting phosphodiesterase 5 inhibitor) on peak urinary flow (Q(max)), bladder capacity, voiding efficiency and the obstructive symptoms of benign prostatic hyperplasia (BPH) in men with lower urinary tract symptoms secondary to BPH (BPH-LUTS), compared with placebo.
  
  
  METHODS
  After a 4-week placebo run-in period, 1058 men with BPH-LUTS were randomly allocated to receive once daily treatment with placebo or tadalafil (2.5, 5, 10, or 20 mg) for 12 weeks. Uroflowmetry, postvoid residual volume (PVR), and BPH symptom score measurements were assessed throughout the trial.
  
  
  RESULTS
  Increases in Q(max) were numerically greater for tadalafil (2.5, 5, 10, and 20 mg with percentage changes of 15%, 16%, 17%, 22%, respectively) vs placebo (12%), but did not reach statistical significance. Age, baseline Q(max), erectile dysfunction history, sexual activity, and previous alpha-blocker therapy significantly influenced the Q(max) response. Tadalafil was not associated with significant changes in PVR. Tadalafil had its greatest effects on bladder capacity and voiding efficiency in men with a Q(max) of <10 mL/s at baseline, but these changes were not significantly different from placebo responses. Tadalafil treatment significantly improved the IPSS obstructive subscores (tadalafil 2.5, 5, 10, 20 mg with percentage changes of 24%, 31%, 33%, 33%, respectively) vs placebo (13%).
  
  
  CONCLUSIONS
  Once daily tadalafil did not significantly change Q(max) or voiding efficiency compared with placebo in men with BPH-LUTS, although there were dose-dependent improvements. No subgroups were identified where tadalafil or placebo treatment had a deleterious effect on Q(max). Despite these minimal changes in uroflowmetric measures, tadalafil was associated with clinically meaningful and statistically significant improvements in the obstructive symptoms of BPH.
authors.affiliation: University of Texas Southwestern Medical Center, Dallas, TX, USA.
authors.forename: Claus G
authors.initials: CG
authors.lastname: Roehrborn
authors.forename: Jed C
authors.initials: JC
authors.lastname: Kaminetsky
authors.forename: Stephen M
authors.initials: SM
authors.lastname: Auerbach
authors.forename: Rafael Martínez
authors.initials: RM
authors.lastname: Montelongo
authors.forename: Albert
authors.initials: A
authors.lastname: Elion-Mboussa
authors.forename: Lars
authors.initials: L
authors.lastname: Viktrup
mesh_terms: D000368:Aged; D002243:Carbolines / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004812:Epidemiologic Methods; D007172:Erectile Dysfunction / Q000188:drug therapy / Q000209:etiology / Q000503:physiopathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000627:therapeutic use*; D011470:Prostatic Hyperplasia / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D053448:Prostatism / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D000068581:Tadalafil; D016896:Treatment Outcome; D014554:Urination / Q000187:drug effects / Q000502:physiology; D014563:Urodynamics / Q000502:physiology
chemical_list: D002243:Carbolines; D010726:Phosphodiesterase Inhibitors; D000068581:Tadalafil