Long-Term Safety and Efficacy of Solifenacin in Children and Adolescents with Overactive Bladder

Purpose: We evaluated the long-term safety and efficacy of once daily oral solifenacinsuspension in children (5 to less than 12 years old) and adolescents (12 to less than 18 years old) with overactive bladder.Materials and Methods: We conducted a 40-week, open label extension of a 12-week double-blind, placebo controlled trial. Outcome measures included incidence and severity of adverse events (primary end point), laboratory variables, vital signs, 12-lead electrocardiogram, post-void residual volume, and change from baseline to end of treatment in mean number of micturitions and incontinence episodes per 24 hours, number of incontinence-free days per 7 days and number of grade 3 or 4 urgency episodes per 24 hours (adolescents only).Results: A total of 119 children and 29 adolescents were enrolled in the study. The incidence of drug related treatment emergent adverse events was 34.7% (children) and 37.9% (adolescents), the most common of which were constipation (11.9%), electrocardiogram QT prolonged (8...