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

Phase 4

Completed

Conditions: Overactive Bladder

Interventions: Biological: onabotulinumtoxinA
Drug: Normal saline

Registration Number: NCT01945489

Lead Sponsor: Allergan

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 254

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo/OnabotulinumtoxinA	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).
OnabotulinumtoxinA	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).
Placebo/OnabotulinumtoxinA	Normal saline	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).

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Daily Average Number of Episodes of Urinary Incontinence	Baseline, Week 12	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.
Percentage of Participants Who Achieve a 100% Reduction in Urinary Incontinence Episodes	Baseline, Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Daily Average Number of Nocturia Episodes	Baseline, Week 12	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.
Change From Baseline in the Daily Average Number of Urgency Episodes	Baseline, Week 12	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 King's Health Questionnaire (KHQ) Domain Scores	Baseline, Week 12	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	Baseline, Week 12	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.

Trial Locations

Locations (39): Genesis Research LLC
🇺🇸
San Diego, California, United States
Deaconess Clinic, Inc.
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Newburgh, Indiana, United States
Urology Associates of Norwalk
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Norwalk, Connecticut, United States
Urologic Clinics of North Alabama
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Huntsville, Alabama, United States
Urology Health Team, PLLC
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Ocala, Florida, United States
Northeast Indiana
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Fort Wayne, Indiana, United States
Atlanta Medical Research Institute
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Alpharetta, Georgia, United States
Bladder and Prostate Health Investigations, LLC
🇺🇸
Miramar, Florida, United States
Regional Urology, LLC
🇺🇸
Shreveport, Louisiana, United States
Alaska Urological Institute dba Alaska Clinical Research Center
🇺🇸
Anchorage, Alaska, United States
South Orange County Medical Research Center
🇺🇸
Laguna Hills, California, United States
Sunrise Medical Research
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Lauderdale Lakes, Florida, United States
Chesapeake Urology Research Associates
🇺🇸
Owings Mills, Maryland, United States
Accumed Research
🇺🇸
Garden City, New York, United States
University of Southern California
🇺🇸
Los Angeles, California, United States
Southeastern Research Group, Inc.
🇺🇸
Tallahassee, Florida, United States
Associated Medical Professionals of New York, PLLC
🇺🇸
Syracuse, New York, United States
Urogynecology Associates
🇺🇸
Indianapolis, Indiana, United States
TriState Urologic Services PSC Inc., dba The Urology Group
🇺🇸
Cincinnati, Ohio, United States
Vanderbilt University Medical Center
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Nashville, Tennessee, United States
U. Colorado, School of Med.
🇺🇸
Aurora, Colorado, United States
Renstar Medical Research
🇺🇸
Ocala, Florida, United States
Urology of Indiana, LLC
🇺🇸
Noblesville, Indiana, United States
Brooklyn Urology Research Group
🇺🇸
Brooklyn, New York, United States
Advanced Urology Centers of NY A division of IMP
🇺🇸
Plainview, New York, United States
Manhattan Medical Research
🇺🇸
New York, New York, United States
Premier Medical Group of the Hudson Valley
🇺🇸
Poughkeepsie, New York, United States
Carolina Urology Partners, PLLC
🇺🇸
Gastonia, North Carolina, United States
University Hospital Case Medical Center
🇺🇸
Cleveland, Ohio, United States
Associated Urologists of North Carolina
🇺🇸
Raleigh, North Carolina, United States
Institute of Pelvic Medicine and Reconstructive Surgery
🇺🇸
Allentown, Pennsylvania, United States
Urologic Consultants of Southern Pennsylvania
🇺🇸
Bala-Cynwyd, Pennsylvania, United States
Mount Nittany Medical Center Health Services, Inc. dba Mount Nittany Physician Group
🇺🇸
State College, Pennsylvania, United States
Virginia Women's Center
🇺🇸
Richmond, Virginia, United States
Urology of Virginia, PLLC
🇺🇸
Virginia Beach, Virginia, United States
Integrity Medical Research, LLC
🇺🇸
Mountlake Terrace, Washington, United States
Virginia Urology
🇺🇸
Richmond, Virginia, United States
The Polyclinic
🇺🇸
Seattle, Washington, United States
Genitourinary Surgical Consultants
🇺🇸
Denver, Colorado, United States