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

Allergan5 sites in 1 country168 target enrollmentNovember 2015

ConditionsUrinary Incontinence Overactive Bladder

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Urinary Incontinence
Sponsor: Allergan
Enrollment: 168
Locations: 5
Primary Endpoint: Change from the baseline in the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) total score
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2015

End Date

July 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Allergan

Responsible Party

Sponsor

Eligibility Criteria

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)