Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition

A Multi-Center, Open-Label (OL), Active-Controlled, Dose-Titration Study Evaluating the Safety, Efficacy and PK of Oxybutynin Transdermal Systems in the Treatment of Detrusor Overactivity in Pediatric Patients

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.

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.

Inclusion Criteria:

• Pediatric patient with a diagnosis of detrusor overactivity associated with a neurological condition;
• Use clean intermittent catheterization
• On stable dose of oral oxybutynin before participation

Exclusion Criteria:

• Have one or more treatable conditions, other than neurogenic bladder dysfunction, that may cause urinary incontinence or urgency
• Have any medical condition that precludes their participation in the study or may confound the outcome of the study