Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Allergan
- Enrollment
- 416
- Locations
- 14
- Primary Endpoint
- Change From Baseline in Number of Weekly Episodes of Urinary Incontinence
Study Overview
Brief Summary
The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis
- •Inadequate response to anticholinergic medication used to treat overactive bladder
Exclusion Criteria
- •History of evidence of pelvic or urologic abnormality
- •Previous or current diagnosis of bladder or prostate cancer
- •Urinary tract infection at time of enrollment
Arms & Interventions
1
botulinum toxin Type A (200U)
Intervention: botulinum toxin Type A (200U) (Biological)
2
botulinum toxin Type A (300U)
Intervention: botulinum toxin Type A (300U) (Biological)
3
placebo; botulinum toxin Type A (200U)
Intervention: Normal Saline (Placebo); botulinum toxin Type A (200U) (Other)
4
placebo; botulinum toxin Type A (300U)
Intervention: Normal Saline (Placebo); botulinum toxin Type A (300U) (Other)
Outcomes
Primary Outcomes
Change From Baseline in Number of Weekly Episodes of Urinary Incontinence
Time Frame: Baseline, Week 6
Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Secondary Outcomes
- Change From Baseline in Maximum Cystometric Capacity (MCC)(Baseline, Week 6)
- Change From Baseline in Maximum Detrusor Pressure (MDP)(Baseline, Week 6)
- Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire(Baseline, Week 6)