A Research Study for Patients With Overactive Bladder
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Overactive Bladder
- Sponsor
- Allergan
- Enrollment
- 313
- Primary Endpoint
- Change in Number of Urinary Urge Incontinence Episodes
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to investigate whether injections of botulinum toxin Type A into the bladder are safe and effective in treating overactive bladder.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Must be between 18-85 years old
- •Must have been diagnosed by his/her doctor with overactive bladder at least 6 months ago
- •Must weigh at least 50 kg (110 lbs)
- •Must be willing and able to record information regarding bladder function into a diary (provided)
- •Must be willing and able to complete the entire course of the study
Exclusion Criteria
- •Cannot currently be catheterizing as a way to control incontinence
- •Must not have used botulinum toxin type A or any other botulinum toxin previously for any condition
Arms & Interventions
Placebo
Placebo (normal saline) injected into detrusor on Day 1
Intervention: Placebo
BOTOX 50 U
botulinum toxin Type A 50 U injected into detrusor on Day 1
Intervention: botulinum toxin Type A
BOTOX 100 U
botulinum toxin Type A 100 U injected into detrusor on Day 1
Intervention: botulinum toxin Type A
BOTOX 150 U
botulinum toxin Type A 150 U injected into detrusor on Day 1
Intervention: botulinum toxin Type A
BOTOX 200 U
botulinum toxin Type A 200 U injected into detrusor on Day 1
Intervention: botulinum toxin Type A
BOTOX 300 U
botulinum toxin Type A 300 U injected into detrusor on Day 1
Intervention: botulinum toxin Type A
Outcomes
Primary Outcomes
Change in Number of Urinary Urge Incontinence Episodes
Time Frame: Baseline, Week 2, Week 6, Week 12
Mean number of urinary urge incontinence episodes measured over a 7-day diary prior to week 12. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate.
Secondary Outcomes
- Change in Number of Nocturia Episodes(Baseline, Week 12)
- Incontinence Quality of Life Instrument (I-QOL)(Baseline, Week 2, Week 6, Week 12)
- Change in Number of Micturitions(Baseline, Week 2, Week 6, Week 12)
- Maximum Cystometric Capacity (MCC) by Urodynamic Measurements(Baseline, Week 12)