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

Study Identifier
191622-518
CT.gov Identifier
NCT00575016
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Details

Medical Condition
  • Bladder Disorder - Overactive Bladder
    • Study Drug
  • Normal saline (Placebo); botulinum toxin Type A (200U)
  • botulinum toxin Type A (50U); botulinum toxin Type A (200U)
  • botulinum toxin Type A (100U); botulinum toxin Type A (200U)
  • botulinum toxin Type A (200U)
    • Phase
    Phase 2
    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 * 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 explore the effectiveness and safety of several doses of botulinum toxin type A in treating overactive bladder in patients with spinal cord injury.

    Study Locations

    Location
    Status
    Location
    Cairo, Egypt
    Status
    Not applicable
    Location
    Thessaloniki, Greece
    Status
    Not applicable
    Location
    Ahmadābād, India
    Status
    Not applicable
    Location
    Beirut, Lebanon
    Status
    Not applicable
    Location
    Belgrade, Serbia
    Status
    Not applicable
    Location
    Ankara, Turkey
    Status
    Not applicable