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

Study Overview
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Brief Summary
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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.

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

Conditions
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Overactive Bladder

Intervention / Treatment
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* Biological: onabotulinumtoxinA
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OnabotulinumtoxinA<br>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<br>* OnabotulinumtoxinA (BOTOX®) injected into the detrusor.<br>* Other names: botulinum toxin Type A;|
| Other: Placebo/OnabotulinumtoxinA<br>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<br>* OnabotulinumtoxinA (BOTOX®) injected into the detrusor.<br>* Other names: botulinum toxin Type A;Drug: Normal saline<br>* Normal saline (placebo) injected into the detrusor.<br>|

What is the study measuring?
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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 |