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

Phase 4

Completed

• Conditions: Urinary Incontinence; Overactive Bladder
• Interventions: Biological: Botulinum Toxin Type A

• Registration Number: NCT02601287
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-06
• Study First Submitted QC: 2015-11-06
• Study First Posted: 2015-11-10
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-19
• Last Update Posted: 2016-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BOTOX® 100U	Botulinum Toxin Type A	Botulinum Toxin Type A 100U into the detrusor muscle on Day 1 in patients with Overactive Bladder
BOTOX® 200U	Botulinum Toxin Type A	Botulinum Toxin Type A 200U into the detrusor muscle on Day 1 in patients with Neurogenic Detrusor Overactivity

Primary Outcome Measures

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

Trial Locations

Locations (5)

Pusan National University Hospital; 🇰🇷 Busan, Korea, Korea, Republic of

The Catholic University of Korea Bucheion St. Mary Hospital; 🇰🇷 Gyeonggi-do, Korea, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Korea, Republic of