A Multi-Center Trial of Botox for Severe Urge Urinary Incontinence
Completed · Not applicable · Has a placebo group
Conditions studied: Urinary Incontinence
In brief
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.
Key facts
- Study ID
- NCT00345332
- Run by
- University of Rochester
- People needed
- 31
- Starts
- 2005-10-01
- Expected to finish
- 2011-05-01
- Last updated by the study team
- 2017-07-11
Who can join
Age: 21 and older, up to 90. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of California at Davis — Sacramento, California, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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