OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder
COMFORT
1 other identifier
interventional
254
1 country
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2013
Typical duration for phase_4
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2013
CompletedFirst Posted
Study publicly available on registry
September 18, 2013
CompletedStudy Start
First participant enrolled
October 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 5, 2017
CompletedResults Posted
Study results publicly available
November 6, 2017
CompletedNovember 6, 2017
September 1, 2017
2.6 years
September 16, 2013
July 25, 2017
October 3, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Baseline, Week 12
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.
Baseline, Week 12
Secondary Outcomes (4)
Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores
Baseline, Week 12
Change From Baseline in the Daily Average Number of Micturition Episodes
Baseline, Week 12
Change From Baseline in the Daily Average Number of Urgency Episodes
Baseline, Week 12
Change From Baseline in the Daily Average Number of Nocturia Episodes
Baseline, Week 12
Study Arms (2)
OnabotulinumtoxinA
EXPERIMENTALOnabotulinumtoxinA (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/OnabotulinumtoxinA
OTHERPlacebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
Interventions
OnabotulinumtoxinA (BOTOX®) injected into the detrusor.
Eligibility Criteria
You may qualify if:
- Patients with symptoms of Overactive Bladder (OAB) (frequency and urgency) with urinary incontinence for at least 6 months prior to screening.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (40)
Urologic Clinics of North Alabama
Huntsville, Alabama, 35801, United States
Alaska Urological Institute dba Alaska Clinical Research Center
Anchorage, Alaska, 99503, United States
South Orange County Medical Research Center
Laguna Hills, California, 92653, United States
University of Southern California
Los Angeles, California, 90033, United States
Genesis Research LLC
San Diego, California, 92123, United States
U. Colorado, School of Med.
Aurora, Colorado, 80045, United States
Genitourinary Surgical Consultants
Denver, Colorado, 80220, United States
Urology Associates of Norwalk
Norwalk, Connecticut, 06850, United States
Sunrise Medical Research
Lauderdale Lakes, Florida, 33319, United States
Bladder and Prostate Health Investigations, LLC
Miramar, Florida, 33029, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Urology Health Team, PLLC
Ocala, Florida, 34474, United States
Southeastern Research Group, Inc.
Tallahassee, Florida, 32308, United States
Atlanta Medical Research Institute
Alpharetta, Georgia, 30005, United States
Northeast Indiana
Fort Wayne, Indiana, 46825, United States
Urogynecology Associates
Indianapolis, Indiana, 46202, United States
Deaconess Clinic, Inc.
Newburgh, Indiana, 47630, United States
Urology of Indiana, LLC
Noblesville, Indiana, 46062, United States
Regional Urology, LLC
Shreveport, Louisiana, 71106, United States
Chesapeake Urology Research Associates
Owings Mills, Maryland, 21117, United States
Brooklyn Urology Research Group
Brooklyn, New York, 11215, United States
Accumed Research
Garden City, New York, 11530, United States
Manhattan Medical Research
New York, New York, 10016, United States
Premier Medical Group of the Hudson Valley
Newburgh, New York, 12550, United States
Advanced Urology Centers of NY A division of IMP
Plainview, New York, 11803, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, 12601, United States
Associated Medical Professionals of New York, PLLC
Syracuse, New York, 13210, United States
Carolina Urology Partners, PLLC
Gastonia, North Carolina, 28054, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, 27612, United States
TriState Urologic Services PSC Inc., dba The Urology Group
Cincinnati, Ohio, 45212, United States
University Hospital Case Medical Center
Cleveland, Ohio, 44106, United States
Institute of Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, 18103, United States
Urologic Consultants of Southern Pennsylvania
Bala-Cynwyd, Pennsylvania, 19004, United States
Mount Nittany Medical Center Health Services, Inc. dba Mount Nittany Physician Group
State College, Pennsylvania, 16801, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Virginia Women's Center
Richmond, Virginia, 23233, United States
Virginia Urology
Richmond, Virginia, 23235, United States
Urology of Virginia, PLLC
Virginia Beach, Virginia, 23462, United States
Integrity Medical Research, LLC
Mountlake Terrace, Washington, 98043, United States
The Polyclinic
Seattle, Washington, 98104, United States
Related Publications (1)
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.
PMID: 32665528DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President Medical Affairs
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Tamer Aboushwareb
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2013
First Posted
September 18, 2013
Study Start
October 28, 2013
Primary Completion
May 24, 2016
Study Completion
January 5, 2017
Last Updated
November 6, 2017
Results First Posted
November 6, 2017
Record last verified: 2017-09