Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder

Study Identifier
191622-516
CT.gov Identifier
NCT00461292
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
  • botulinum toxin Type A (200U)
  • botulinum toxin Type A (300U)
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 80 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis * Inadequate response to anticholinergic medication used to treat overactive bladder
    Exclusion Criteria:
    * History or evidence of pelvic or urologic abnormality * Previous or current diagnosis of bladder or prostate cancer * Urinary tract infection at time of enrollment

    Protocol Summary

    The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients

    Study Locations

    Location
    Status
    Location
    Middlebury, Connecticut, United States
    Status
    Not applicable
    Location
    Rio de Janeiro, Brazil
    Status
    Not applicable
    Location
    Victoria, British Columbia, Canada
    Status
    Not applicable
    Location
    Salouël, France
    Status
    Not applicable
    Location
    Milan, Italy
    Status
    Not applicable
    Location
    Amsterdam, Netherlands
    Status
    Not applicable
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