OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder

Study Identifier
GMA-OAB-113
CT.gov Identifier
NCT01945489
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Bladder Disorder - Overactive Bladder
    • Study Drug
  • onabotulinumtoxinA
  • Normal saline
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    -Patients with symptoms of Overactive Bladder (OAB) (frequency and urgency) with urinary incontinence for at least 6 months prior to screening.
    Exclusion Criteria:
    * Symptoms of OAB due to a neurological reason * Use of anticholinergics or other medications or therapies to treat symptoms of OAB within 7 days of screening * Use of Clean Intermittent Catheterization (CIC) or indwelling catheter to manage urinary incontinence * Use of botulinum toxin therapy of any serotype for any urological condition * Use of botulinum toxin therapy of any serotype for any non-urological condition in the 12 weeks prior to screening * History of any pelvic or urological abnormalities, bladder surgery or disease, other than OAB, that may affect bladder function * Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, or Amyotrophic Lateral Sclerosis.

    Protocol Summary

    This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared with placebo, in achieving a 100% reduction in urinary incontinence in patients with overactive bladder (OAB) not properly managed with an anticholinergic.

    Study Locations

    Location
    Status
    Location
    Urologic Clinics of North Alabama
    Huntsville, Alabama, United States, 35801
    Status
    Not applicable
    Location
    Alaska Urological Institute dba Alaska Clinical Research Center
    Anchorage, Alaska, United States, 99503
    Status
    Not applicable
    Location
    South Orange County Medical Research Center
    Laguna Hills, California, United States, 92653
    Status
    Not applicable
    Location
    University of Southern California
    Los Angeles, California, United States, 90033
    Status
    Not applicable
    Location
    Genesis Research LLC
    San Diego, California, United States, 92123
    Status
    Not applicable
    Location
    U. Colorado, School of Med.
    Aurora, Colorado, United States, 80045
    Status
    Not applicable
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