Tolterodine treatment improves storage symptoms suggestive of overactive bladder in men treated with alpha-blockers

Eur Urol. 2009 Sep;56(3):534-41. doi: 10.1016/j.eururo.2008.11.026. Epub 2008 Nov 24.


Background: Some men receiving alpha-blocker therapy for lower urinary tract symptoms report persistent storage symptoms suggestive of overactive bladder (OAB).

Objective: To evaluate the efficacy of tolterodine extended release (ER) in men on alpha-blocker therapy.

Design, setting, and participants: This double-blind trial included men aged > or = 40 yr with frequency, urgency, and at least moderate problems reported on the Patient Perception of Bladder Condition (PPBC), despite being on a stable dose of alpha-blocker for > or = 1 mo.

Interventions: Subjects were randomized to tolterodine ER 4 mg per day or placebo for 12 wk while continuing their prescribed alpha-blocker therapy.

Measurements: At baseline and week 12, subjects completed the PPBC, International Prostate Symptom Score (IPSS), Overactive Bladder Questionnaire (OAB-q), and 5-d bladder diaries using the five-point Urinary Sensation Scale (USS). Frequency-urgency sum was defined as the sum of USS ratings for all micturitions.

Results and limitations: PPBC improvement from baseline to week 12 was reported by 63.6% and 61.6% of subjects receiving tolterodine ER plus alpha-blocker and placebo plus alpha-blocker, respectively; this treatment difference, which was the primary end point, was not statistically significant (p>0.6699). At week 12, subjects receiving tolterodine ER plus alpha-blocker had significantly greater improvements versus placebo plus alpha-blocker in 24-h micturitions (-1.8 vs -1.2; p=0.0079) and daytime micturitions (-1.3 vs -0.8; p=0.0123); 24-h urgency episodes (-2.9 vs -1.8; p=0.0010), daytime urgency episodes (-2.2 vs -1.4; p=0.0017), and nocturnal urgency episodes (-0.5 vs -0.3; p=0.0378); frequency-urgency sum (-7.8 vs -5.1; p=0.0065); IPSS storage subscale (-2.6 vs -2.1; p=0.0370); and OAB-q symptom bother scale (-17.9 vs -14.4; p=0.0086) and coping domain (15.4 vs 12.4; p=0.0491). Acute urinary retention requiring catheterization occurred in < 1% of either group. There were no clinically meaningful changes in postvoid residual volume or maximum urinary flow rate.

Conclusions: Men with bothersome OAB symptoms despite continued alpha-blocker therapy showed significantly greater improvements in diary variables, IPSS Storage scores, and symptom bother when receiving additional tolterodine ER versus placebo plus alpha-blocker.

Trial registration: NCT00282932.

Publication types

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

MeSH terms

  • Adrenergic alpha-Antagonists / therapeutic use*
  • Adult
  • Aged
  • Aged, 80 and over
  • Benzhydryl Compounds / therapeutic use*
  • Cresols / therapeutic use*
  • Double-Blind Method
  • Drug Therapy, Combination
  • Humans
  • Male
  • Middle Aged
  • Muscarinic Antagonists / therapeutic use*
  • Phenylpropanolamine / therapeutic use*
  • Prospective Studies
  • Prostatism / complications
  • Prostatism / drug therapy
  • Tolterodine Tartrate
  • Urinary Bladder, Overactive / diagnosis
  • Urinary Bladder, Overactive / drug therapy*
  • Urinary Bladder, Overactive / etiology


  • Adrenergic alpha-Antagonists
  • Benzhydryl Compounds
  • Cresols
  • Muscarinic Antagonists
  • Phenylpropanolamine
  • Tolterodine Tartrate

Associated data