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
Phase 4
Completed
- Conditions
- Urinary IncontinenceOveractive Bladder
- Registration Number
- NCT02601287
- Lead Sponsor
- Allergan
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 168
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change from the baseline in the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) total score Baseline, Day 28
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Pusan National University Hospital
🇰🇷Busan, Korea, Korea, Republic of
The Catholic University of Korea Bucheion St. Mary Hospital
🇰🇷Gyeonggi-do, Korea, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Korea, Republic of
Pusan National University Hospital🇰🇷Busan, Korea, Korea, Republic of