Study of OnabotulinumtoxinA for Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Pediatric Patients

Status:	Completed
Conditions:	Overactive Bladder, Urology
Therapuetic Areas:	Gastroenterology, Nephrology / Urology
Healthy:	No
Age Range:	5 - 17
Updated:	12/9/2018
Start Date:	June 2, 2013
End Date:	October 11, 2018

BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 5 to 17 Years of Age

This study will evaluate the safety and efficacy of onabotulinumtoxinA for the treatment of
urinary incontinence due to neurogenic detrusor overactivity in pediatric patients between
the ages of 5 to 17 years.

Inclusion Criteria:

- Urinary incontinence due to neurogenic detrusor overactivity

- Regularly using clean intermittent catheterization to empty the bladder

Exclusion Criteria:

- Surgery of the spinal cord within 6 months

- Diagnosis of cerebral palsy

- Current or planned use of a baclofen pump

- Current or planned use of an electrostimulation/neuromodulation device for urinary
incontinence

- Use of an indwelling catheter for urinary incontinence instead of using clean
intermittent catheterization to empty the bladder

- Previous or current use of botulinum toxin therapy of any serotype for any urological
condition, or treatment with botulinum toxin of any serotype within 3 months for any
other condition or use

- Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis

We found this trial at

sites

Cincinnati Children's Hospital Medical Center Cincinnati Center for Clinical Research and Outpatient Clinic

Cincinnati, Ohio 45229

from

Cincinnati, OH