Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Pediatric Patients

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 3 doses of onabotulinumtoxinA (botulinum toxin Type A) for the treatment of urinary incontinence due to neurogenic detrusor overactivity in pediatric participants between the ages of 5 to 17 years to determine if 1 or more doses were safe and effective.

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