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Double-blind, placebo-controlled multicentre trial of tolterodine in children with frequency and urgency.
The efficacy and safety of tolterodine in children with frequency and urgency have not been established. We evaluated the efficacy and safety of tolterodine in children. We performed a randomized, double-blind, placebo-controlled, multicentre, parallel-group, parallel-design, non-inferiority study. Tolterodine was administered for 3 months. Efficacy variables were frequency of urination, daytime and nighttime urinary urgency, functional bladder capacity, daytime frequency, and daytime and nighttime incontinence. Safety variables were adverse events, vital signs, hematologic and biochemical variables. Efficacy data were analyzed by intent-to-treat. Non-inferiority was considered to be shown if the upper bound of the one-sided 95% CI for the tolterodine minus placebo difference in average change in frequency of voids from baseline to the end of treatment was
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