OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder
Overview
- Phase
- Phase 4
- Intervention
- onabotulinumtoxinA
- Conditions
- Overactive Bladder
- Sponsor
- Allergan
- Enrollment
- 254
- Locations
- 39
- Primary Endpoint
- Change From Baseline in the Daily Average Number of Episodes of Urinary Incontinence
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
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).
Intervention: onabotulinumtoxinA
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).
Intervention: onabotulinumtoxinA
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).
Intervention: Normal saline
Outcomes
Primary Outcomes
Change From Baseline in the Daily Average Number of Episodes of Urinary Incontinence
Time Frame: 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
Time Frame: 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 Outcomes
- Change From Baseline in the Daily Average Number of Nocturia Episodes(Baseline, Week 12)
- Change From Baseline in the Daily Average Number of Urgency Episodes(Baseline, Week 12)
- Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores(Baseline, Week 12)
- Change From Baseline in the Daily Average Number of Micturition Episodes(Baseline, Week 12)