Status:
COMPLETED
A Long-Term Extension Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity
Lead Sponsor:
Allergan
Conditions:
Urinary Incontinence
Eligibility:
All Genders
5-17 years
Phase:
PHASE3
Brief Summary
This study will evaluate the long-term safety and efficacy of onabotulinumtoxinA (botulinum toxin Type A; BOTOX®) for the treatment of urinary incontinence due to neurogenic detrusor overactivity in p...
Eligibility Criteria
Inclusion
- Successfully completed participation in Study 191622-120
- Aged ≥ 5 years to ≤ 17 years at the time of entry into Study 191622-120
- Regularly using clean intermittent catheterization to empty the bladder
Exclusion
- Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
- 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 for any other condition since entering study 191622-120
Key Trial Info
Start Date :
January 11 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2019
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT01852058
Start Date
January 11 2014
End Date
October 3 2019
Last Update
May 12 2020
Active Locations (30)
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1
University of Alabama at Birmingham Division of Urology Research Office
Birmingham, Alabama, United States, 35294
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