Back to resultsOnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder (COMFORT)
Primary Purpose
Overactive Bladder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
onabotulinumtoxinA
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder
Eligibility Criteria
Inclusion Criteria:
-Patients with symptoms of Overactive Bladder (OAB) (frequency and urgency) with urinary incontinence for at least 6 months prior to screening.
Exclusion Criteria:
- Symptoms of OAB due to a neurological reason
- Use of anticholinergics or other medications or therapies to treat symptoms of OAB within 7 days of screening
- Use of Clean Intermittent Catheterization (CIC) or indwelling catheter to manage urinary incontinence
- Use of botulinum toxin therapy of any serotype for any urological condition
- Use of botulinum toxin therapy of any serotype for any non-urological condition in the 12 weeks prior to screening
- History of any pelvic or urological abnormalities, bladder surgery or disease, other than OAB, that may affect bladder function
- Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, or Amyotrophic Lateral Sclerosis.
Sites / Locations
- Urologic Clinics of North Alabama
- Alaska Urological Institute dba Alaska Clinical Research Center
- South Orange County Medical Research Center
- University of Southern California
- Genesis Research LLC
- U. Colorado, School of Med.
- Genitourinary Surgical Consultants
- Urology Associates of Norwalk
- Sunrise Medical Research
- Bladder and Prostate Health Investigations, LLC
- Renstar Medical Research
- Urology Health Team, PLLC
- Southeastern Research Group, Inc.
- Atlanta Medical Research Institute
- Northeast Indiana
- Urogynecology Associates
- Deaconess Clinic, Inc.
- Urology of Indiana, LLC
- Regional Urology, LLC
- Chesapeake Urology Research Associates
- Brooklyn Urology Research Group
- Accumed Research
- Manhattan Medical Research
- Premier Medical Group of the Hudson Valley
- Advanced Urology Centers of NY A division of IMP
- Premier Medical Group of the Hudson Valley
- Associated Medical Professionals of New York, PLLC
- Carolina Urology Partners, PLLC
- Associated Urologists of North Carolina
- TriState Urologic Services PSC Inc., dba The Urology Group
- University Hospital Case Medical Center
- Institute of Pelvic Medicine and Reconstructive Surgery
- Urologic Consultants of Southern Pennsylvania
- Mount Nittany Medical Center Health Services, Inc. dba Mount Nittany Physician Group
- Vanderbilt University Medical Center
- Virginia Women's Center
- Virginia Urology
- Urology of Virginia, PLLC
- Integrity Medical Research, LLC
- The Polyclinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
OnabotulinumtoxinA
Placebo/OnabotulinumtoxinA
Arm Description
OnabotulinumtoxinA (BOTOX®) 100U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
Placebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
Outcomes
Primary Outcome Measures
Percentage of Participants Who Achieve a 100% Reduction in Urinary Incontinence Episodes
Urinary incontinence is defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes were averaged daily during this period and compared to baseline to determine 100% reduction in episodes.
Change From Baseline in the Daily Average Number of Episodes of Urinary Incontinence
Urinary incontinence is defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes were averaged daily during this period. A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.
Secondary Outcome Measures
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores
The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of participants with urinary incontinence. The questionnaire consists of 7 domains, including emotions, personal relationships, physical limitations, role limitations, severity (coping) measures, sleep/energy and social limitations. Domain scores range from 0 to 100, with a lower score indicating a preferable health status (absence of urinary incontinence impacts). A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates a worsening.
Change From Baseline in the Daily Average Number of Micturition Episodes
The number of micturition episodes (the number of times a patient urinates into the toilet) in Treatment Cycle 1 was recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of micturition episodes were averaged daily during this period A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.
Change From Baseline in the Daily Average Number of Urgency Episodes
The number of daily urgency episodes (the number of times a patient experiences the urgency to urinate) in Treatment Cycle 1 was recorded by the patient in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of urgency episodes were averaged daily during this period A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.
Change From Baseline in the Daily Average Number of Nocturia Episodes
Nocturia episodes were recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of nocturia episodes were averaged daily during this period. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. A negative number change from Baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01945489
Brief Title
OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder
Acronym
COMFORT
Official Title
OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 28, 2013 (Actual)
Primary Completion Date
May 24, 2016 (Actual)
Study Completion Date
January 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared with placebo, in achieving a 100% reduction in urinary incontinence in patients with overactive bladder (OAB) not properly managed with an anticholinergic.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
254 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OnabotulinumtoxinA
Arm Type
Experimental
Arm Description
OnabotulinumtoxinA (BOTOX®) 100U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
Arm Title
Placebo/OnabotulinumtoxinA
Arm Type
Other
Arm Description
Placebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
Intervention Type
Biological
Intervention Name(s)
onabotulinumtoxinA
Other Intervention Name(s)
BOTOX®, botulinum toxin Type A
Intervention Description
OnabotulinumtoxinA (BOTOX®) injected into the detrusor.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Normal saline (placebo) injected into the detrusor.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieve a 100% Reduction in Urinary Incontinence Episodes
Description
Urinary incontinence is defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes were averaged daily during this period and compared to baseline to determine 100% reduction in episodes.
Time Frame
Baseline, Week 12
Title
Change From Baseline in the Daily Average Number of Episodes of Urinary Incontinence
Description
Urinary incontinence is defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes were averaged daily during this period. A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores
Description
The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of participants with urinary incontinence. The questionnaire consists of 7 domains, including emotions, personal relationships, physical limitations, role limitations, severity (coping) measures, sleep/energy and social limitations. Domain scores range from 0 to 100, with a lower score indicating a preferable health status (absence of urinary incontinence impacts). A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates a worsening.
Time Frame
Baseline, Week 12
Title
Change From Baseline in the Daily Average Number of Micturition Episodes
Description
The number of micturition episodes (the number of times a patient urinates into the toilet) in Treatment Cycle 1 was recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of micturition episodes were averaged daily during this period A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.
Time Frame
Baseline, Week 12
Title
Change From Baseline in the Daily Average Number of Urgency Episodes
Description
The number of daily urgency episodes (the number of times a patient experiences the urgency to urinate) in Treatment Cycle 1 was recorded by the patient in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of urgency episodes were averaged daily during this period A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.
Time Frame
Baseline, Week 12
Title
Change From Baseline in the Daily Average Number of Nocturia Episodes
Description
Nocturia episodes were recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of nocturia episodes were averaged daily during this period. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. A negative number change from Baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Time Frame
Baseline, Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-Patients with symptoms of Overactive Bladder (OAB) (frequency and urgency) with urinary incontinence for at least 6 months prior to screening.
Exclusion Criteria:
Symptoms of OAB due to a neurological reason
Use of anticholinergics or other medications or therapies to treat symptoms of OAB within 7 days of screening
Use of Clean Intermittent Catheterization (CIC) or indwelling catheter to manage urinary incontinence
Use of botulinum toxin therapy of any serotype for any urological condition
Use of botulinum toxin therapy of any serotype for any non-urological condition in the 12 weeks prior to screening
History of any pelvic or urological abnormalities, bladder surgery or disease, other than OAB, that may affect bladder function
Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, or Amyotrophic Lateral Sclerosis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamer Aboushwareb
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Urologic Clinics of North Alabama
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Alaska Urological Institute dba Alaska Clinical Research Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99503
Country
United States
Facility Name
South Orange County Medical Research Center
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Genesis Research LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
U. Colorado, School of Med.
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Genitourinary Surgical Consultants
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Urology Associates of Norwalk
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06850
Country
United States
Facility Name
Sunrise Medical Research
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Bladder and Prostate Health Investigations, LLC
City
Miramar
State/Province
Florida
ZIP/Postal Code
33029
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Urology Health Team, PLLC
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Southeastern Research Group, Inc.
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Atlanta Medical Research Institute
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Northeast Indiana
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
Urogynecology Associates
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Deaconess Clinic, Inc.
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
Urology of Indiana, LLC
City
Noblesville
State/Province
Indiana
ZIP/Postal Code
46062
Country
United States
Facility Name
Regional Urology, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Owings Mills
State/Province
Maryland
ZIP/Postal Code
21117
Country
United States
Facility Name
Brooklyn Urology Research Group
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Accumed Research
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Manhattan Medical Research
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Premier Medical Group of the Hudson Valley
City
Newburgh
State/Province
New York
ZIP/Postal Code
12550
Country
United States
Facility Name
Advanced Urology Centers of NY A division of IMP
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
Country
United States
Facility Name
Premier Medical Group of the Hudson Valley
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Associated Medical Professionals of New York, PLLC
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Carolina Urology Partners, PLLC
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Associated Urologists of North Carolina
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
TriState Urologic Services PSC Inc., dba The Urology Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
University Hospital Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Institute of Pelvic Medicine and Reconstructive Surgery
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Urologic Consultants of Southern Pennsylvania
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Mount Nittany Medical Center Health Services, Inc. dba Mount Nittany Physician Group
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Virginia Women's Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
Facility Name
Virginia Urology
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Urology of Virginia, PLLC
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
Integrity Medical Research, LLC
City
Mountlake Terrace
State/Province
Washington
ZIP/Postal Code
98043
Country
United States
Facility Name
The Polyclinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32665528
Citation
McCammon K, Gousse A, Kohan A, Glazier D, Gruenenfelder J, Bai Z, Patel A, Hale D. Early and Consistent Improvements in Urinary Symptoms and Quality of Life With OnabotulinumtoxinA in Patients With Overactive Bladder and Urinary Incontinence: Results From a Randomized, Placebo-controlled, Phase IV Clinical Trial. Female Pelvic Med Reconstr Surg. 2021 Jul 1;27(7):450-456. doi: 10.1097/SPV.0000000000000914.
Results Reference
derived
Learn more about this trial
OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder
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