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

Allergan168 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

168

Conditions

Urinary Incontinence Overactive Bladder

Interventions

Botulinum Toxin Type ABIOLOGICAL

Botulinum Toxin Type A into detrusor muscle on Day 1

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (5)

Pusan National University Hospital

Busan, Korea, South Korea

The Catholic University of Korea Bucheion St. Mary Hospital

Gyeonggi-do, Korea, South Korea

Seoul National University Hospital

Seoul, Korea, South Korea

Asan Medical Center

Seoul, Korea, South Korea

Outcomes

Primary Outcomes

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

Time frame: Baseline, Day 28

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.