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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Detrusor Hyperreflexia

Intervention / Treatment
-----------------
* Drug: Oxybutynin
* Drug: Oxybutynin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxybutynin Transdermal System<br>Oxybutynin Transdermal System 1.3 mg/day, 2.6 mg/day, or 3.9 mg/day | Drug: Oxybutynin<br>* 1.3, 2.6, 3.9 mg/day transdermal<br>* Other names: Oxytrol;|
| Active Comparator: Oral oxybutynin<br>5 to 15 mg/day immediate release or extended release tablets, or syrup | Drug: Oxybutynin<br>* 5 to 15 mg/day immediate release or extended release tablets, or syrup<br>* Other names: Ditropan, Ditropan XL, Oxybutynin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Catheterization Urine Volume | Change from baseline in average volume of urine collected by catheterization | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catheterizations Without Leakage | Percentage of catherizations without leakage | 14 weeks | 
| Urine Volume After First Awakening | Change from baseline in average volume of urine collected after first morning awakening | 14 weeks |