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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
254
OnabotulinumtoxinA (BOTOX®) injected into the detrusor.
Normal saline (placebo) injected into the detrusor.
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.
Time frame: 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.
Time frame: Baseline, Week 12
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.
Time frame: 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.
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Urologic Clinics of North Alabama
Huntsville, Alabama, 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
University of Southern California
Los Angeles, California, United States
Genesis Research LLC
San Diego, California, United States
U. Colorado, School of Med.
Aurora, Colorado, United States
Genitourinary Surgical Consultants
Denver, Colorado, United States
Urology Associates of Norwalk
Norwalk, Connecticut, United States
Sunrise Medical Research
Lauderdale Lakes, Florida, United States
Bladder and Prostate Health Investigations, LLC
Miramar, Florida, United States
...and 30 more locations
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 12