Status:
COMPLETED
A Multi-Center Trial of Botox for Severe Urge Urinary Incontinence
Lead Sponsor:
University of Rochester
Conditions:
Urinary Incontinence
Eligibility:
FEMALE
21-90 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00345332
Start Date
October 1 2005
End Date
May 1 2011
Last Update
July 11 2017
Active Locations (3)
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1
University of California at Davis
Sacramento, California, United States, 95817
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
3
Duke University Medical Center
Durham, North Carolina, United States, 27710