OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder (COMFORT)

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Biological: onabotulinumtoxinA; Drug: Normal saline

• Study Type: Interventional
• Enrollment (Actual): 254
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Urologic Clinics of North Alabama
  • Alaska
    • Anchorage, Alaska, United States, 99503
      • Alaska Urological Institute dba Alaska Clinical Research Center
  • California
    • Laguna Hills, California, United States, 92653
      • South Orange County Medical Research Center
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • San Diego, California, United States, 92123
      • Genesis Research LLC
  • Colorado
    • Aurora, Colorado, United States, 80045
      • U. Colorado, School of Med.
    • Denver, Colorado, United States, 80220
      • Genitourinary Surgical Consultants
  • Connecticut
    • Norwalk, Connecticut, United States, 06850
      • Urology Associates of Norwalk
  • Florida
    • Lauderdale Lakes, Florida, United States, 33319
      • Sunrise Medical Research
    • Miramar, Florida, United States, 33029
      • Bladder and Prostate Health Investigations, LLC
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research
    • Ocala, Florida, United States, 34474
      • Urology Health Team, PLLC
    • Tallahassee, Florida, United States, 32308
      • Southeastern Research Group, Inc.
  • Georgia
    • Alpharetta, Georgia, United States, 30005
      • Atlanta Medical Research Institute
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Northeast Indiana
    • Indianapolis, Indiana, United States, 46202
      • Urogynecology Associates
    • Newburgh, Indiana, United States, 47630
      • Deaconess Clinic, Inc.
    • Noblesville, Indiana, United States, 46062
      • Urology of Indiana, LLC
  • Louisiana
    • Shreveport, Louisiana, United States, 71106
      • Regional Urology, LLC
  • Maryland
    • Owings Mills, Maryland, United States, 21117
      • Chesapeake Urology Research Associates
  • New York
    • Brooklyn, New York, United States, 11215
      • Brooklyn Urology Research Group
    • Garden City, New York, United States, 11530
      • AccuMed Research
    • New York, New York, United States, 10016
      • Manhattan Medical Research
    • Newburgh, New York, United States, 12550
      • Premier Medical Group of the Hudson Valley
    • Plainview, New York, United States, 11803
      • Advanced Urology Centers of NY A division of IMP
    • Poughkeepsie, New York, United States, 12601
      • Premier Medical Group of the Hudson Valley
    • Syracuse, New York, United States, 13210
      • Associated Medical Professionals of New York, PLLC
  • North Carolina
    • Gastonia, North Carolina, United States, 28054
      • Carolina Urology Partners, PLLC
    • Raleigh, North Carolina, United States, 27612
      • Associated Urologists of North Carolina
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • TriState Urologic Services PSC Inc., dba The Urology Group
    • Cleveland, Ohio, United States, 44106
      • University Hospital Case Medical Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Institute of Pelvic Medicine and Reconstructive Surgery
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Urologic Consultants of Southern Pennsylvania
    • State College, Pennsylvania, United States, 16801
      • Mount Nittany Medical Center Health Services, Inc. dba Mount Nittany Physician Group
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Virginia
    • Richmond, Virginia, United States, 23233
      • Virginia Women's Center
    • Richmond, Virginia, United States, 23235
      • Virginia Urology
    • Virginia Beach, Virginia, United States, 23462
      • Urology of Virginia, PLLC
  • Washington
    • Mountlake Terrace, Washington, United States, 98043
      • Integrity Medical Research, LLC
    • Seattle, Washington, United States, 98104
      • The Polyclinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: OnabotulinumtoxinA; 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).	Biological: onabotulinumtoxinA; OnabotulinumtoxinA (BOTOX®) injected into the detrusor.; Other Names: BOTOX®; botulinum toxin Type A
OTHER: Placebo/OnabotulinumtoxinA; 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).	Biological: onabotulinumtoxinA; OnabotulinumtoxinA (BOTOX®) injected into the detrusor.; Other Names: BOTOX®; botulinum toxin Type A; Drug: Normal saline; Normal saline (placebo) injected into the detrusor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 12
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.	Baseline, Week 12
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.	Baseline, Week 12
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.	Baseline, Week 12

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Tamer Aboushwareb, Allergan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 28, 2013
• Primary Completion (ACTUAL): May 24, 2016
• Study Completion (ACTUAL): January 5, 2017

Study Registration Dates

• First Submitted: September 16, 2013
• First Submitted That Met QC Criteria: September 16, 2013
• First Posted (ESTIMATE): September 18, 2013

Study Record Updates

• Last Update Posted (ACTUAL): November 6, 2017
• Last Update Submitted That Met QC Criteria: October 3, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Bladder, Overactive; Urinary Incontinence; Enuresis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: GMA-OAB-113

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No