Status:
COMPLETED
Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Pediatric Patients
Lead Sponsor:
Allergan
Conditions:
Urinary Incontinence
Eligibility:
All Genders
5-17 years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Urinary incontinence due to neurogenic detrusor overactivity
- Regularly using clean intermittent catheterization to empty the bladder
Exclusion
- 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
Key Trial Info
Start Date :
July 2 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2018
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT01852045
Start Date
July 2 2013
End Date
October 11 2018
Last Update
November 21 2019
Active Locations (31)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
Children's Hospital of Orange County
Orange, California, United States, 92868
4
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611