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

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Overactive Bladder Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pusan National University Hospital, Busan, Korea, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Botulinum toxin type A

Biological

Botulinum Toxin Type A into detrusor muscle on Day 1

Other names: BOTOX®, onabotulinumtoxinA

Primary outcomes

Change from the baseline in the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) total score

Time frame: Baseline, Day 28

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Nov 10, 2015
Registry last updated: Jul 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed