title: Urodynamic effects of once daily tadalafil in men with lower urinary tract symptoms secondary to clinical benign prostatic hyperplasia: a randomized, placebo controlled 12-week clinical trial.
abstract: OBJECTIVE
  We explored the impact of once daily tadalafil on urodynamic measures in men with lower urinary tract symptoms secondary to clinical benign prostatic hyperplasia via invasive and noninvasive urodynamic studies.
  
  
  METHODS
  We conducted a multicenter, randomized, double blind, placebo controlled clinical trial comparing once daily tadalafil 20 mg vs placebo during 12 weeks in men with lower urinary tract symptoms secondary to clinical benign prostatic hyperplasia with or without bladder outlet obstruction. Invasive and noninvasive urodynamics, International Prostate Symptom Score and general safety were assessed. The primary study end point was change in detrusor pressure at maximum urinary flow rate.
  
  
  RESULTS
  Urodynamic measures remained largely unchanged during the study with no statistically significant or clinically adverse difference between tadalafil and placebo in change in detrusor pressure at maximum urinary flow rate (mean difference between treatments -2.2 cm H(2)O, p = 0.33) or any other urodynamic parameter assessed including maximum urinary flow rate, maximum detrusor pressure, bladder outlet obstruction index or bladder capacity (all measures p > or = 0.13). Treatment with tadalafil resulted in significant improvements in International Prostate Symptom Score (mean difference between treatments -4.2, p < 0.001). Tadalafil was generally well tolerated with the majority of adverse events being mild to moderate in severity and few patients discontinuing due to adverse events (tadalafil 2.0%, placebo 1.0%).
  
  
  CONCLUSIONS
  Treatment with tadalafil once daily for lower urinary tract symptoms secondary to clinical benign prostatic hyperplasia showed no negative impact on bladder function as measured by detrusor pressure at maximum urinary flow rate or on any other urodynamic parameter assessed. Nonetheless men receiving tadalafil reported significant improvements in International Prostate Symptom Score with an adverse events profile similar to other recent studies of tadalafil for lower urinary tract symptoms secondary to clinical benign prostatic hyperplasia.
authors.affiliation: Department of Urology, Vanderbilt University, Nashville, Tennessee, USA. roger.dmochowski@Vanderbilt.Edu
authors.forename: Roger
authors.initials: R
authors.lastname: Dmochowski
authors.forename: Claus
authors.initials: C
authors.lastname: Roehrborn
authors.forename: Suzanne
authors.initials: S
authors.lastname: Klise
authors.forename: Lei
authors.initials: L
authors.lastname: Xu
authors.forename: Jed
authors.initials: J
authors.lastname: Kaminetsky
authors.forename: Stephen
authors.initials: S
authors.lastname: Kraus
mesh_terms: D002243:Carbolines / Q000008:administration & dosage* / Q000494:pharmacology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D008297:Male; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage* / Q000494:pharmacology; D011470:Prostatic Hyperplasia / Q000150:complications* / Q000503:physiopathology; D053448:Prostatism / Q000188:drug therapy* / Q000209:etiology* / Q000503:physiopathology; D000068581:Tadalafil; D013997:Time Factors; D014563:Urodynamics / Q000187:drug effects*
chemical_list: D002243:Carbolines; D010726:Phosphodiesterase Inhibitors; D000068581:Tadalafil