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