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

July 19, 2016 updated by: Allergan
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Korea
      • Busan, Korea, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Gyeonggi-do, Korea, Korea, Republic of, 14647
        • The Catholic University of Korea Bucheion St. Mary Hospital
      • Seoul, Korea, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Korea, Republic of, 03080
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BOTOX® 100U
Botulinum Toxin Type A 100U into the detrusor muscle on Day 1 in patients with Overactive Bladder
Biological: Botulinum Toxin Type A
Botulinum Toxin Type A into detrusor muscle on Day 1
Other Names:
  • BOTOX®
  • onabotulinumtoxinA
Experimental: BOTOX® 200U
Botulinum Toxin Type A 200U into the detrusor muscle on Day 1 in patients with Neurogenic Detrusor Overactivity
Biological: Botulinum Toxin Type A
Botulinum Toxin Type A into detrusor muscle on Day 1
Other Names:
  • BOTOX®
  • onabotulinumtoxinA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from the baseline in the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) total score
Time Frame: Baseline, Day 28
Baseline, Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Investigators

  • Study Director: Medical Contact, Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

November 6, 2015

First Submitted That Met QC Criteria

November 6, 2015

First Posted (Estimate)

November 10, 2015

Study Record Updates

Last Update Posted (Estimate)

July 21, 2016

Last Update Submitted That Met QC Criteria

July 19, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 191622-151

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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