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

Area of Science:

• Pediatric Urology
• Pharmacology
• Clinical Trials

Background:

• Overactive bladder (OAB) significantly impacts children's quality of life.
• Limited data exists on tolterodine's use in pediatric populations.
• Establishing safe and effective dosing in children is crucial.

Purpose of the Study:

• To evaluate the safety, efficacy, and pharmacokinetics of oral tolterodine in children with OAB.
• To determine the optimal dosage of tolterodine for pediatric OAB treatment.

Main Methods:

• An open-label, dose-escalation study involving 33 children (aged 5-10 years) with OAB.
• Treatment with oral tolterodine at 0.5 mg, 1 mg, or 2 mg twice daily for 14 days.
• Safety assessed by changes in residual urinary volume, adverse events, and laboratory variables; efficacy by voiding diary outcomes.

Main Results:

• No significant safety concerns observed regarding residual urinary volume across all doses.
• Adverse events were generally mild and infrequent, with headache being most common.
• Improvements in OAB symptoms (frequency, incontinence) were noted, with greatest efficacy at 1 mg and 2 mg twice daily.
• Pharmacokinetics demonstrated dose linearity.

Conclusions:

• Tolterodine is safe and effective for treating OAB in children aged 5-10 years.
• A dosage of 1 mg twice daily is identified as optimal for this pediatric population.
• Further research may explore long-term outcomes and broader age ranges.