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)

Allergan

Status and phase: Completed; Phase 3

Conditions: Multiple Sclerosis; Neurogenic Bladder; Urinary Incontinence

Treatments: Drug: Placebo (Normal Saline); Biological: OnabotulinumtoxinA

Study type: Interventional

Funder types: Industry

Identifiers

NCT01600716

191622-117

Details and patient eligibility

About

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.

Enrollment: 144 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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144 participants in 2 patient groups

OnabotulinumtoxinA

Experimental group

Description:

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.

Treatment:

Biological: OnabotulinumtoxinA

Placebo (Normal Saline)

Other group

Description:

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.

Treatment:

Drug: Placebo (Normal Saline)

Biological: OnabotulinumtoxinA