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

Overactive Bladder Clinical Trial

— COMFORT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01945489
• Other study ID #: GMA-OAB-113
• Status: Completed
• Phase: Phase 4
• First received: September 16, 2013
• Last updated: October 3, 2017
• Start date: October 28, 2013
• Est. completion date: January 5, 2017

Study information

• Verified date: September 2017
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: January 5, 2017
• Est. primary completion date: May 24, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Incontinence

Intervention

Biological:
• onabotulinumtoxinA
OnabotulinumtoxinA (BOTOX®) injected into the detrusor.

Drug:
• Normal saline
Normal saline (placebo) injected into the detrusor.

Locations

Country	Name	City	State
United States	Institute of Pelvic Medicine and Reconstructive Surgery	Allentown	Pennsylvania
United States	Atlanta Medical Research Institute	Alpharetta	Georgia
United States	Alaska Urological Institute dba Alaska Clinical Research Center	Anchorage	Alaska
United States	U. Colorado, School of Med.	Aurora	Colorado
United States	Urologic Consultants of Southern Pennsylvania	Bala-Cynwyd	Pennsylvania
United States	Brooklyn Urology Research Group	Brooklyn	New York
United States	TriState Urologic Services PSC Inc., dba The Urology Group	Cincinnati	Ohio
United States	University Hospital Case Medical Center	Cleveland	Ohio
United States	Genitourinary Surgical Consultants	Denver	Colorado
United States	Northeast Indiana	Fort Wayne	Indiana
United States	Accumed Research	Garden City	New York
United States	Carolina Urology Partners, PLLC	Gastonia	North Carolina
United States	Urologic Clinics of North Alabama	Huntsville	Alabama
United States	Urogynecology Associates	Indianapolis	Indiana
United States	South Orange County Medical Research Center	Laguna Hills	California
United States	Sunrise Medical Research	Lauderdale Lakes	Florida
United States	University of Southern California	Los Angeles	California
United States	Bladder and Prostate Health Investigations, LLC	Miramar	Florida
United States	Integrity Medical Research, LLC	Mountlake Terrace	Washington
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Manhattan Medical Research	New York	New York
United States	Deaconess Clinic, Inc.	Newburgh	Indiana
United States	Premier Medical Group of the Hudson Valley	Newburgh	New York
United States	Urology of Indiana, LLC	Noblesville	Indiana
United States	Urology Associates of Norwalk	Norwalk	Connecticut
United States	Renstar Medical Research	Ocala	Florida
United States	Urology Health Team, PLLC	Ocala	Florida
United States	Chesapeake Urology Research Associates	Owings Mills	Maryland
United States	Advanced Urology Centers of NY A division of IMP	Plainview	New York
United States	Premier Medical Group of the Hudson Valley	Poughkeepsie	New York
United States	Associated Urologists of North Carolina	Raleigh	North Carolina
United States	Virginia Urology	Richmond	Virginia
United States	Virginia Women's Center	Richmond	Virginia
United States	Genesis Research LLC	San Diego	California
United States	The Polyclinic	Seattle	Washington
United States	Regional Urology, LLC	Shreveport	Louisiana
United States	Mount Nittany Medical Center Health Services, Inc. dba Mount Nittany Physician Group	State College	Pennsylvania
United States	Associated Medical Professionals of New York, PLLC	Syracuse	New York
United States	Southeastern Research Group, Inc.	Tallahassee	Florida
United States	Urology of Virginia, PLLC	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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