The overactive bladder in children: a potential future indication for tolterodine

Objective To determine the safety, efficacy and pharmacokinetics of toltero dine in children with an overactive bladder. Patients and methods Thirty-three children (20 boys and 13 girls, aged 5-10 years) with an overactive bladder and symptoms of urgency, frequency and/o r urge incontinence were enrolled in an open, dose-escalation study. Patien ts were treated with oral tolterodine 0.5 mg (n=11), 1 mg (n=10) or 2 mg (n =12)twice daily for 14 days. The primary safety endpoint was the change in residual urinary volume, as determined by ultrasonography. In addition, voi ding diary variables (frequency and incontinence episodes) and pharmacokine tics were evaluated. Other safety endpoints included laboratory variables, electrocardiogram recordings and reported adverse events. Results There were no safety concerns in terms of the change in residual ur inary volume for any of the three dosage groups; Values were comparable wit h baseline after 2 weeks of treatment for all three dosages. Adverse events were reported by 20 patients (six on 0.5 mg, five on 1 mg, and nine on 2 m g). Most adverse events were not considered to be drug-related: of the 13 p ossibly related events, 10 occurred in those taking 2 mg, Headache was the most commonly reported adverse event. No serious adverse events were report ed and there were no general safety concerns. There was an improvement in v oiding diary variables in all treatment groups after 2 weeks of treatment, although the efficacy was greatest in those taking 1 mg and 2 mg, Pharmacok inetic findings were consistent with dose linearity over the range consiste nt 0.5-2 mg. Conclusion The results support the use of 1 mg twice daily as the optimal d ose of tolterodine for treating children aged 5-10 years with an overactive bladder.