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

NCT02601287 | Completed Phase 4

• 1 other identifier: 191622-151
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 5

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.

Conditions

Urinary Incontinence; Overactive Bladder

Outcome Measures

Primary Outcomes (1)

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

  Baseline, Day 28

Study Arms (2)

BOTOX® 100U

EXPERIMENTAL

Botulinum Toxin Type A 100U into the detrusor muscle on Day 1 in patients with Overactive Bladder

Biological: Botulinum Toxin Type A

BOTOX® 200U

EXPERIMENTAL

Botulinum Toxin Type A 200U into the detrusor muscle on Day 1 in patients with Neurogenic Detrusor Overactivity

Biological: Botulinum Toxin Type A

Interventions

Botulinum Toxin Type A BIOLOGICAL

Botulinum Toxin Type A into detrusor muscle on Day 1

Also known as: BOTOX®, onabotulinumtoxinA

BOTOX® 100U; BOTOX® 200U

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Allergan: lead

Study Sites (5)

Pusan National University Hospital

Busan, Korea, 49241, South Korea

Location

The Catholic University of Korea Bucheion St. Mary Hospital

Gyeonggi-do, Korea, 14647, South Korea

Location

Seoul National University Hospital

Seoul, Korea, 03080, South Korea

Location

Asan Medical Center

Seoul, Korea, 05505, South Korea

Location

Samsung Medical Center

Seoul, Korea, 06351, South Korea

Location

MeSH Terms

Conditions

Urinary Incontinence; Urinary Bladder, Overactive

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Medical Contact

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: November 10, 2015
• Study Start: November 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 21, 2016

Record last verified: 2016-07

Locations

KR (5)