Safety and Efficacy Study of OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity (NDO) in Non-Catheterizing Patients With Multiple Sclerosis (MS)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-13

Study Completion Date

2015-03-27

Brief Summary

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This study will evaluate the safety and efficacy of OnabotulinumtoxinA (BOTOX®) for the treatment of urinary incontinence due to NDO in non-catheterizing patients with MS.

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Detailed Description

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Conditions

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Urinary Incontinence Multiple Sclerosis Neurogenic Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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OnabotulinumtoxinA

OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA 100 U injection.

Group Type EXPERIMENTAL

OnabotulinumtoxinA

Intervention Type BIOLOGICAL

OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1 in the onabotulinumtoxinA 100 U arm. After a minimum of 12 weeks, patients in both the onabotulinumtoxinA 100 U arm and the placebo arm could request/qualify for an onabotulinumtoxinA injection.

Placebo (Normal Saline)

Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.

Group Type OTHER

OnabotulinumtoxinA

Intervention Type BIOLOGICAL

OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1 in the onabotulinumtoxinA 100 U arm. After a minimum of 12 weeks, patients in both the onabotulinumtoxinA 100 U arm and the placebo arm could request/qualify for an onabotulinumtoxinA injection.

Placebo (Normal Saline)

Intervention Type DRUG

Placebo (normal saline) is administered into the detrusor at Day 1.

Interventions

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OnabotulinumtoxinA

OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1 in the onabotulinumtoxinA 100 U arm. After a minimum of 12 weeks, patients in both the onabotulinumtoxinA 100 U arm and the placebo arm could request/qualify for an onabotulinumtoxinA injection.

Intervention Type BIOLOGICAL

Placebo (Normal Saline)

Placebo (normal saline) is administered into the detrusor at Day 1.

Intervention Type DRUG

Other Intervention Names

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BOTOX® botulinum toxin Type A

Eligibility Criteria

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Inclusion Criteria

* At least 3 episodes of urinary incontinence over a 3-day period
* History of Multiple Sclerosis (MS)
* Urinary incontinence not adequately controlled by anticholinergic medication

Exclusion Criteria

* Current use of intermittent catheter or indwelling catheter to manage urinary incontinence
* Previous or current botulinum toxin therapy of any serotype for any urological condition
* Previous or current botulinum toxin therapy of any serotype for any non-urological condition within the last 12 weeks
* Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, or Amyotrophic Lateral Sclerosis

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No