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

Allergan

Status and phase: Completed; Phase 4

Conditions: Urinary Incontinence; Overactive Bladder

Treatments: Biological: Botulinum Toxin Type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02601287

191622-151

Details and patient eligibility

About

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.

Enrollment: 168 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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168 participants in 2 patient groups

BOTOX® 100U

Experimental group

Description:

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

Treatment:

Biological: Botulinum Toxin Type A

BOTOX® 200U

Experimental group

Description:

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

Treatment:

Biological: Botulinum Toxin Type A