Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Pediatric Patients

Allergan

Status and phase: Completed; Phase 3

Conditions: Urinary Incontinence

Treatments: Biological: OnabotulinumtoxinA

Study type: Interventional

Funder types: Industry

Identifiers

NCT01852045

191622-120

2012-004877-26 (EudraCT Number)

Details and patient eligibility

About

This study will evaluate the 3 doses of onabotulinumtoxinA (botulinum toxin Type A) for the treatment of urinary incontinence due to neurogenic detrusor overactivity in pediatric participants between the ages of 5 to 17 years to determine if 1 or more doses were safe and effective.

Enrollment: 114 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Urinary incontinence due to neurogenic detrusor overactivity
• Regularly using clean intermittent catheterization to empty the bladder

Exclusion criteria

• Surgery of the spinal cord within 6 months
• Diagnosis of cerebral palsy
• Current or planned use of a baclofen pump
• Current or planned use of an electrostimulation/neuromodulation device for urinary incontinence
• Use of an indwelling catheter for urinary incontinence instead of using clean intermittent catheterization to empty the bladder
• Previous or current use of botulinum toxin therapy of any serotype for any urological condition, or treatment with botulinum toxin of any serotype within 3 months for any other condition or use
• Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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114 participants in 3 patient groups

OnabotulinumtoxinA 50 U

Experimental group

Description:

OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 (NCT01852058) if qualified.

Treatment:

Biological: OnabotulinumtoxinA

OnabotulinumtoxinA 100 U

Experimental group

Description:

OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 if qualified.

Treatment:

Biological: OnabotulinumtoxinA

OnabotulinumtoxinA 200 U

Experimental group

Description:

OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 if qualified.

Treatment:

Biological: OnabotulinumtoxinA