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)

Phase 3

Completed

• Conditions: Multiple Sclerosis; Neurogenic Bladder; Urinary Incontinence
• Interventions: Biological: OnabotulinumtoxinA; Drug: Placebo (Normal Saline)

• Registration Number: NCT01600716
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2012-05-15
• Study First Submitted QC: 2012-05-15
• Study First Posted: 2012-05-17
• Study Start: 2012-06-13
• Primary Completion: 2014-04-04
• Study Completion: 2015-03-27
• Disposition First Submitted: 2015-04-29
• Disposition First Submitted QC: 2015-06-15
• Disposition First Posted: 2015-07-13
• Results First Submitted: 2016-02-17
• Results First Submitted QC: 2016-02-17
• Results First Posted: 2016-03-22
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-17
• Last Update Posted: 2019-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OnabotulinumtoxinA	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.
Placebo (Normal Saline)	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.
Placebo (Normal Saline)	OnabotulinumtoxinA	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Daily Average Frequency of Urinary Incontinence Episodes	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 Outcome Measures

Name	Time	Method
Change From Baseline in Incontinence Quality of Life Instrument (I-QOL) Total Summary Score	Baseline, Week 6	The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL, and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0=worst QOL and 100=best QOL). A positive change from baseline represents an improvement and a negative change from baseline represents a worsening.
Change From Baseline in Maximum Cystometric Capacity (MCC)	Baseline, Week 6	MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in the maximum volume of urine the bladder holds and a negative number change from baseline represents a worsening (decrease) in the maximum volume of urine the bladder holds.
Change From Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC)	Baseline, Week 6	Maximum detrusor pressure represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. A negative number change from baseline indicates an improvement in pressure and a positive number change from baseline indicates a worsening in pressure.