Conditions: Detrusor Hyperreflexia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 57
Healthy volunteers: no

Brief summary:
This study will evaluate the safety and effectiveness of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in children who have a neurological condition (e.g. spina bifida) that contributes to their overactive bladder.

Detailed description:
This study will use a multicenter, randomized, open-label, active-controlled, dose-titration, parallel group design, in approximately pediatric patients with detrusor overactivity associated with a neurological condition.

Arms:
arm 1: Oxybutynin Transdermal System 1.3 mg/day, 2.6 mg/day, or 3.9 mg/day arm 2: 5 to 15 mg/day immediate release or extended release tablets, or syrup

Interventions: intervention 1: Oxybutynin intervention 2: Oxybutynin
Intervention descriptions: intervention 1: 1.3, 2.6, 3.9 mg/day transdermal intervention 2: 5 to 15 mg/day immediate release or extended release tablets, or syrup

Protocol document: