A Safety and Efficacy Study of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder in Korean Patients

Study Identifier
191622-151
CT.gov Identifier
NCT02601287
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
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis * Symptoms of urge urinary incontinence, urgency, and frequency due to overactive bladder
    Exclusion Criteria:
    * Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis * Use of botulinum toxin therapy of any serotype in the 3 months prior to screening * Has acute urinary retention who do not routinely perform clean intermittent self-catheterization (CIC)

    Protocol Summary

    This is a safety and efficacy study of BOTOX® (Botulinum Toxin Type A) in the Treatment of Adult Korean Patients with Urinary Incontinence due to Neurogenic Detrusor Overactivity or Overactive Bladder.

    Study Locations

    Location
    Status
    Location
    Pusan National University Hospital
    Busan, Korea, Republic of Korea, 49241
    Status
    Not applicable
    Location
    The Catholic University of Korea Bucheion St. Mary Hospital
    Gyeonggi-do, Korea, Republic of Korea, 14647
    Status
    Not applicable
    Location
    Seoul National University Hospital
    Seoul, Korea, Republic of Korea, 03080
    Status
    Not applicable
    Location
    Asan Medical Center
    Seoul, Korea, Republic of Korea, 05505
    Status
    Not applicable
    Location
    Samsung Medical Center
    Seoul, Korea, Republic of Korea, 06351
    Status
    Not applicable