Back to resultsSafety 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)
Primary Purpose
Urinary Incontinence, Multiple Sclerosis, Neurogenic Bladder
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
OnabotulinumtoxinA
Placebo (Normal Saline)
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
OnabotulinumtoxinA
Placebo (Normal Saline)
Arm 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.
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.
Outcomes
Primary Outcome Measures
Change From Baseline in Daily Average Frequency of Urinary Incontinence Episodes
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
Change From Baseline in Maximum Cystometric Capacity (MCC)
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)
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.
Change From Baseline in Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01600716
Brief Title
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 Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 13, 2012 (Actual)
Primary Completion Date
April 4, 2014 (Actual)
Study Completion Date
March 27, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Multiple Sclerosis, Neurogenic Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OnabotulinumtoxinA
Arm Type
Experimental
Arm 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.
Arm Title
Placebo (Normal Saline)
Arm Type
Other
Arm 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.
Intervention Type
Biological
Intervention Name(s)
OnabotulinumtoxinA
Other Intervention Name(s)
BOTOX®, botulinum toxin Type A
Intervention Description
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
Drug
Intervention Name(s)
Placebo (Normal Saline)
Intervention Description
Placebo (normal saline) is administered into the detrusor at Day 1.
Primary Outcome Measure Information:
Title
Change From Baseline in Daily Average Frequency of Urinary Incontinence Episodes
Description
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).
Time Frame
Baseline, Week 6
Secondary Outcome Measure Information:
Title
Change From Baseline in Maximum Cystometric Capacity (MCC)
Description
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.
Time Frame
Baseline, Week 6
Title
Change From Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC)
Description
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.
Time Frame
Baseline, Week 6
Title
Change From Baseline in Incontinence Quality of Life Instrument (I-QOL) Total Summary Score
Description
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.
Time Frame
Baseline, Week 6
Other Pre-specified Outcome Measures:
Title
Duration of Treatment Effect Through Week 52
Description
The duration of treatment effect is the time to patient request for retreatment.
Time Frame
Up to 52 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Mountlake Terrace
State/Province
Washington
Country
United States
City
Liege
Country
Belgium
City
Victoria
State/Province
British Columbia
Country
Canada
City
Kitchener
State/Province
Ontario
Country
Canada
City
Olomouc
Country
Czechia
City
Garches
Country
France
City
Marseille
Country
France
City
Warsaw
Country
Poland
City
Porto
Country
Portugal
City
St. Petersburg
Country
Russian Federation
12. IPD Sharing Statement
Citations:
PubMed Identifier
30030330
Citation
Tullman M, Chartier-Kastler E, Kohan A, Keppenne V, Brucker BM, Egerdie B, Mandle M, Nicandro JP, Jenkins B, Denys P. Low-dose onabotulinumtoxinA improves urinary symptoms in noncatheterizing patients with MS. Neurology. 2018 Aug 14;91(7):e657-e665. doi: 10.1212/WNL.0000000000005991. Epub 2018 Jul 20.
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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)
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