Tolterodine Treatment Improves Storage Symptoms Suggestive of Overactive Bladder in Men Treated With α-Blockers

Background: Some men receiving a-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 >= 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 a-blocker for >= 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. (C) 2008 European Association of Urology. Published by Elsevier B.V. All rights reserved.