Objectives: To investigate whether the combination of tolterodine plus (Tp) a simple pelvic floor muscle exercise (PFME) program would provide improved treatment benefits compared with tolterodine alone (Ta) in patients with symptoms of overactive bladder (OAB).
Methods: After a 1-2 week run-in period, 480 patients with symptoms of urinary frequency (> or =8 micturitions/24 hr), urgency, and urge incontinence (> or =1 episode/24 hr), were randomized to receive tolterodine 2 mg bid with or without a simple PFME program for 24 weeks in this multinational study. Treatment efficacy was assessed by comparing the change from baseline in 3-day micturition diary recordings.
Results: After 24 weeks' treatment, in the Ta group the urgency episodes reduced from mean of 4.1 to 1.5 (83% reduction) while in the Tp group the urgency episodes reduced from 4.2 to 2.1 (78.7% reduction). Mean incontinence episodes per day decreased from 3.21 (standard deviation (SD) 3.4) to 0.95 (SD 1.9) in Ta group and from 3.44 (SD 3.4) to 1.25 (SD 2.7) in the Tp group. Similarly, the number of micturition/24 hr were significantly reduced, from 12.78 to 9.20 (27.3% reduction) in the Ta group and from 11.87 to 9.29 (23% reduction) in the Tp group. There was an improvement in the patients' perception of urinary symptoms in 85.9% of patients on Ta and 81.7% patients on Tp PFME. There were no statistically significant differences between the groups with regard to any of the outcome parameters.
Conclusions: Tolterodine therapy for 24 weeks results in significant improvement in urgency, frequency, and incontinence, however, no additional benefit was demonstrated for a simple PFME program.
Copyright 2003 Wiley-Liss, Inc.