A Long-Term Extension Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity

Study Identifier
191622-121
CT.gov Identifier
NCT01852058
EudraCT Identifier
2012-004898-30
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Statistical Analysis Plan
Available Language(s): English
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Protocol
Available Language(s): English
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Study Details

Medical Condition
  • Bladder Disorder - Overactive Bladder
    • Study Drug
  • OnabotulinumtoxinA
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    5 - 17 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * 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 Criteria:
    * 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

    Protocol 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 participants who successfully completed Study 191622-120 (NCT01852045).

    Study Locations

    Location
    Status
    Location
    University of Alabama at Birmingham Division of Urology Research Office
    Birmingham, Alabama, United States, 35294
    Status
    Not applicable
    Location
    Cedars-Sinai Medical Center
    Los Angeles, California, United States, 90048
    Status
    Not applicable
    Location
    Children's Hospital of Orange County
    Orange, California, United States, 92868
    Status
    Not applicable
    Location
    Ann & Robert H. Lurie Children's Hospital of Chicago
    Chicago, Illinois, United States, 60611
    Status
    Not applicable
    Location
    Riley Hospital for Children
    Indianapolis, Indiana, United States, 46032
    Status
    Not applicable
    Location
    William Beaumont Hospital Research Institute
    Royal Oak, Michigan, United States, 48073
    Status
    Not applicable
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