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NCT02601287 Clinical 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

Urinary Incontinence Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02601287
Other study ID # 191622-151
Secondary ID
Status Completed
Phase Phase 4
First received November 6, 2015
Last updated July 19, 2016
Start date November 2015
Est. completion date July 2016

Study information
Verified date July 2016
Source Allergan
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 168
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• Botulinum Toxin Type A
Botulinum Toxin Type A into detrusor muscle on Day 1

Locations
Country Name City State
Korea, Republic of Pusan National University Hospital Busan Korea
Korea, Republic of The Catholic University of Korea Bucheion St. Mary Hospital Gyeonggi-do Korea
Korea, Republic of Asan Medical Center Seoul Korea
Korea, Republic of Samsung Medical Center Seoul Korea
Korea, Republic of Seoul National University Hospital Seoul Korea

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from the baseline in the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) total score Baseline, Day 28 No
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