A Safety and Efficacy Study of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive... | NCT02601287 | Trialant
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
ClinicalTrials.gov ID
NCT02601287
Lead Sponsor
AllerganINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 4
Enrollment
168Actual
Last Update Posted
Jul 21, 2016Estimated
Start Date
Nov 2015
Primary Completion Date
Jul 2016Actual
Completion Date
Jul 2016Actual
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.
Urinary Incontinence
Overactive Bladder
Botulinum Toxin Type A
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility 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)
Primary Purpose
Treatment
Allocation
Non-Randomized
Interventional Model
Single Group Assignment
Masking
None (Open Label)
No central contacts
There are no central contacts for this study.
Pusan National University Hospital
Busan, Korea 49241, South Korea
The Catholic University of Korea Bucheion St. Mary Hospital