Effects of tolterodine extended release on patient perception of bladder condition and overactive bladder symptoms*.

OBJECTIVE

To evaluate the efficacy of tolterodine extended release (ER) versus placebo at 1 and 12 weeks using questionnaires and diary measures.

RESEARCH DESIGN AND

METHODS

Subjects with overactive bladder (OAB) were randomized to receive tolterodine ER (4 mg) or placebo for 12 weeks. This double-blind study is registered with ClinicalTrials.gov (identifier: NCT00143377).

MAIN OUTCOME MEASURES: Subjects completed the Patient Perception of Bladder Condition (PPBC) and 3-day bladder diaries at baseline and weeks 1 and 12, and the Overactive Bladder Questionnaire (OAB-q) at baseline and week 12. PPBC score changes were analyzed using 2-category (improvement, no improvement), 3-category (improvement, no change, deterioration), and 4-category (>or=2-point improvement, 1-point improvement, no change, deterioration) stratifications. Categorical change in PPBC scores from baseline to week 12 was the primary endpoint.

RESULTS

A total of 617 subjects were randomized (tolterodine ER, n = 410; placebo, n = 207). At week 1, a significantly higher percentage of subjects receiving tolterodine ER reported improvement on the PPBC compared with placebo (p < 0.05). Subjects receiving tolterodine ER also had a significantly greater reduction in all OAB symptoms versus placebo (all p < 0.05). At week 12, a higher percentage of tolterodine ER subjects reported PPBC improvement versus placebo subjects. This was significant in the 3- and 4-category analyses (both p < 0.05) but not in the 2-category analysis (the prespecified method of analysis; p = 0.098). Compared with the placebo group, the tolterodine ER group reported significantly greater week 12 improvements in all bladder diary variables (all p < 0.01) as well as in OAB-q Symptom Bother, total Health-Related Quality of Life, Coping, and Concern scores (all p <or= 0.02).

CONCLUSIONS

Compared with placebo, subjects receiving tolterodine ER reported significantly greater improvements in nondiary patient-reported outcomes and OAB symptoms at week 12. Improvements in subjects' perception of their bladder-related problems and in OAB symptoms were observed as early as week 1. Further research is required to assess which aspects of subjects' bladder-related problems were improved. A large placebo effect may have prevented the prespecified 2-category analysis of PPBC improvement from reaching statistical significance at week 12, which was the primary endpoint.