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

Study Identifier
191622-082
CT.gov Identifier
NCT00439140
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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Study Details

Medical Condition
  • Bladder Disorder - Overactive Bladder
    • Study Drug
  • botulinum toxin Type A
  • Normal Saline (Placebo)
    • 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. * Neurological respiratory impairment and abnormal pulmonary function test results
    Exclusion Criteria:
    * History or evidence of pelvic or urologic abnormality * Previous or current diagnosis of bladder or prostate cancer * Symptomatic or untreated urinary tract infection at time of enrollment

    Protocol Summary

    This study will assess the safety and efficacy of botulinum toxin Type A for the treatment of urinary incontinence overactive bladder in patients with a spinal cord injury or multiple sclerosis.

    Study Locations

    Location
    Status
    Location
    Philadelphia, Pennsylvania, United States
    Status
    Not applicable
    Location
    Herston, Queensland, Australia
    Status
    Not applicable
    Location
    Victoria, British Columbia, Canada
    Status
    Not applicable
    Location
    Chennai, India
    Status
    Not applicable