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)
Overview
- Phase
- Phase 3
- Intervention
- OnabotulinumtoxinA
- Conditions
- Urinary Incontinence
- Sponsor
- Allergan
- Enrollment
- 144
- Primary Endpoint
- Change From Baseline in Daily Average Frequency of Urinary Incontinence Episodes
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: OnabotulinumtoxinA
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.
Intervention: OnabotulinumtoxinA
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.
Intervention: Placebo (Normal Saline)
Outcomes
Primary Outcomes
Change From Baseline in Daily Average Frequency of Urinary Incontinence Episodes
Time Frame: Baseline, Week 6
Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. The number of episodes of urinary incontinence is recorded over a 3-day period the week of the study visit. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change indicates an increase in incontinence episodes (worsening).
Secondary Outcomes
- Change From Baseline in Incontinence Quality of Life Instrument (I-QOL) Total Summary Score(Baseline, Week 6)
- Change From Baseline in Maximum Cystometric Capacity (MCC)(Baseline, Week 6)
- Change From Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC)(Baseline, Week 6)