Back to resultsA 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
Primary Purpose
Urinary Incontinence, Overactive Bladder
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence
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)
Sites / Locations
- Pusan National University Hospital
- The Catholic University of Korea Bucheion St. Mary Hospital
- Seoul National University Hospital
- Asan Medical Center
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
BOTOX® 100U
BOTOX® 200U
Arm Description
Botulinum Toxin Type A 100U into the detrusor muscle on Day 1 in patients with Overactive Bladder
Botulinum Toxin Type A 200U into the detrusor muscle on Day 1 in patients with Neurogenic Detrusor Overactivity
Outcomes
Primary Outcome Measures
Change from the baseline in the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) total score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02601287
Brief Title
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 Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Overactive Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
168 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BOTOX® 100U
Arm Type
Experimental
Arm Description
Botulinum Toxin Type A 100U into the detrusor muscle on Day 1 in patients with Overactive Bladder
Arm Title
BOTOX® 200U
Arm Type
Experimental
Arm Description
Botulinum Toxin Type A 200U into the detrusor muscle on Day 1 in patients with Neurogenic Detrusor Overactivity
Intervention Type
Biological
Intervention Name(s)
Botulinum Toxin Type A
Other Intervention Name(s)
BOTOX®, onabotulinumtoxinA
Intervention Description
Botulinum Toxin Type A into detrusor muscle on Day 1
Primary Outcome Measure Information:
Title
Change from the baseline in the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) total score
Time Frame
Baseline, Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Contact
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Pusan National University Hospital
City
Busan
State/Province
Korea
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Bucheion St. Mary Hospital
City
Gyeonggi-do
State/Province
Korea
ZIP/Postal Code
14647
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Korea
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
State/Province
Korea
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Korea
ZIP/Postal Code
06351
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
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
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