Oxybutynin Chloride Gel for Detrusor Overactivity (Overactive Bladder in Children) - Clinical Trial

What is the Purpose of this Study?


We are doing this study to find out an investigational drug called oxybutynin chloride 10% topical gel (the study drug) is a safe and effective treatment for children who have bladder control problems. The study drug is an ointment that is applied to the skin.

What is the Condition Being Studied?

Overactive Bladder in Children

Who Can Participate in the Study?

Key Eligibility

Children younger than 18 years who:
- Are diagnosed with neurogenic bladder

For more information about this study, please contact the study team at urologyresearch@duke.edu.

Age Group

What is Involved?


If your child chooses to join this study, they will:
- Visit our clinic 6 times over approximately 16 weeks
- Use the study drug (topical gel applied to skin) as directed by the study doctor
- Have physical exams
- Have heart scans (ECG)
- Have blood draws and give urine samples
- Answer questionnaires and keep a log of their urinary habits

Study Details

Full Title
A Two-part, Multicenter, Dose-titration Study Evaluating the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Oxybutynin Chloride 10% Gel for the Treatment of Detrusor Overactivity Associated With a Neurological Condition in Pediatric Patients
Principal Investigator
Pediatric Urologist
Protocol Number
IRB: PRO00107186
NCT: NCT01192568
Phase IV
Enrollment Status
Open for Enrollment