Safety and efficacy of tolterodine extended release in men with overactive bladder symptoms and presumed non-obstructive benign prostatic hyperplasia

World J Urol. 2007 Dec;25(6):627-33. doi: 10.1007/s00345-007-0212-5. Epub 2007 Sep 29.

Abstract

Patients with presumed non-obstructive BPH (Q (max )>or= 15 ml/s) treated with tolterodine ER 4 mg/day for OAB symptoms, alone or added to unsuccessful alpha-blocker treatment of >or=6 weeks duration, were observed for 12 weeks in a non-interventional study to generate real-life efficacy and safety data. Patients completed the IPSS, the OAB-q and a 2-day micturition diary at baseline and 12 weeks. PVR was determined sonographically. Seven hundred and forty one patients were analysed. Mean PVR did not increase (25.4 +/- 26.5 vs. 29.3 +/- 30.9 ml at baseline). AUR requiring catheterization occurred in two patients, acute UTI in four patients. Median IPSS total scores decreased from 17 to 10, IPSS QoL scores from 4 to 2, OAB-q symptom bother scores from 50.0 to 22.5 and OAB-q HRQL scores increased from 59.2 to 81.6. In men with OAB symptoms and presumed non-obstructive BPH, tolterodine ER provided considerable symptomatic and QoL improvements with a low risk of AUR, acute UTI, or increased PVR.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Benzhydryl Compounds / administration & dosage*
  • Benzhydryl Compounds / adverse effects
  • Cresols / administration & dosage*
  • Cresols / adverse effects
  • Delayed-Action Preparations
  • Humans
  • Male
  • Middle Aged
  • Muscarinic Antagonists / administration & dosage*
  • Muscarinic Antagonists / adverse effects
  • Phenylpropanolamine / administration & dosage*
  • Phenylpropanolamine / adverse effects
  • Prostatic Hyperplasia / drug therapy*
  • Prostatic Hyperplasia / psychology
  • Quality of Life
  • Regression Analysis
  • Severity of Illness Index
  • Tolterodine Tartrate
  • Treatment Outcome
  • Urinary Bladder, Overactive / drug therapy*
  • Urinary Bladder, Overactive / psychology
  • Urinary Incontinence, Urge / drug therapy
  • Urinary Incontinence, Urge / psychology
  • Urodynamics

Substances

  • Benzhydryl Compounds
  • Cresols
  • Delayed-Action Preparations
  • Muscarinic Antagonists
  • Phenylpropanolamine
  • Tolterodine Tartrate