NCT00345332CompletedNot Applicable
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial of Botox for Severe Refractory Urge Urinary Incontinence
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Rochester
- Enrollment
- 31
- Locations
- 3
- Primary Endpoint
- Incontinent Episodes Per Day
Study Overview
Brief Summary
The purpose of the study is to determine how effective Botox is in reducing the amount of urine leaked and which dose of Botox is more effective and safe in those who have urinary urge incontinence.
Detailed Description
A multi-center clinical trial of Botulinum-A Toxin (Botox) for refractory urge incontinence.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 90 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Female subjects 21-90 years of age
- •subjects has urinary incontinence on 3 day bladder diary
- •subject has severe incontinence
- •urine dipstick or urine culture negative for urinary tract infection
- •cystometrogram without stress urinary leakage
- •must have failed at least one anti-cholinergic medication
- •negative urine pregnancy test on day of administration of study medication
Exclusion Criteria
- •history of carcinoma of the bladder
- •presence of foreign body in the bladder, cystitis or other correctable etiology for Urge Urinary Incontinance
- •gross fecal incontinence
- •known allergy to sulfa or ciprofloxacin or to lidocaine
- •any medical condition that may put the subject at increased risk with exposure to Botox
- •females who are pregnant, breast-feeding, or planning a pregnancy during the study or who are of child-bearing potential
- •known allergy to any of the components in the study medication
- •prior documented resistance to Botox
- •evidence of recent alcohol or drug abuse
- •concurrent participation in another investigational drug or device study within 30 days
Arms & Interventions
1
Placebo Comparator
Placebo
Intervention: Placebo (Drug)
2
Experimental
Botox
Intervention: Botox (Drug)
Outcomes
Primary Outcomes
Incontinent Episodes Per Day
Time Frame: week 13
The number of incontinence episodes per day was recorded by each participant in a diary. All incontinence episodes were counted when calculating episodes per day at each time point.
Secondary Outcomes
- Number of Incontinence Pads Used Per Day(week 13)
Investigators
Study Sites (3)
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