BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence

Study Identifier
1839-201-021
CT.gov Identifier
NCT03320850
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

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

Medical Condition
  • Bladder Disorder - Overactive Bladder
    • Study Drug
  • OnabotulinumtoxinA and Hydrogel admixture
  • Placebo and Hydrogel admixture
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months * Inadequate response or limiting side effects with pharmacotherapy for the treatment of OAB
    Exclusion Criteria:
    * Overactive Bladder caused by neurological condition * Patient has predominance of stress incontinence * History or evidence of pelvic or urological abnormality * Prior use of BOTOX for any urological condition

    Protocol Summary

    This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in participants with overactive bladder and urinary incontinence.

    Study Locations

    Location
    Status
    Location
    University of Alabama at Birmingham
    Birmingham, Alabama, United States, 35249
    Status
    Not applicable
    Location
    Coastal Clinical Research, Inc., an AMR company
    Mobile, Alabama, United States, 36608
    Status
    Not applicable
    Location
    Urological Assoc. of South AZ
    Tucson, Arizona, United States, 85715
    Status
    Not applicable
    Location
    Hope Clinical Research
    Canoga Park, California, United States, 91303
    Status
    Not applicable
    Location
    San Bernardino Urological Associates Medical Group
    San Bernardino, California, United States, 92404
    Status
    Not applicable
    Location
    Wr-McCr, Llc
    San Diego, California, United States, 92108
    Status
    Not applicable
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