A Multi-Center Trial of Botox for Severe Urge Urinary Incontinence
Information source: University of Rochester
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urinary Incontinence
Intervention: Botox (Drug); Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Rochester Official(s) and/or principal investigator(s):
Michael K Flynn, MD, Principal Investigator, Affiliation: University of Rochester
Overall contact:
Mare Perevich, RN, Phone: 585-273-2996, Email: mare_perevich@urmc.rochester.edu
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.
Clinical Details
Official title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial of Botox for Severe Refractory Urge Urinary Incontinence
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Bladder diary, number of daily incontinence episodes
Secondary outcome: Number of pads used, quality-of-life questionnaires
Eligibility
Minimum age: 21 Years.
Maximum age: 90 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Female subjects 21-90 years of age
- subjects has urinary incontinence on 3 day blader diary
- subject has severe incontinence
- urine dipstick or urine colture 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, cyctitis or other correctable etiology for
UUI
- 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
Locations and Contacts
Mare Perevich, RN, Phone: 585-273-2996, Email: mare_perevich@urmc.rochester.edu
University of California at Davis, Sacramento, California 95817, United States; Terminated
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States; Terminated
Duke University Medical Center, Durham, North Carolina 27710, United States; Recruiting
Jean Maynor, RN, Phone: 919-684-4647, Email: jean.maynor@duke.edu
Cindy Amundsen, MD, Principal Investigator
Additional Information
Starting date: October 2005
Last updated: June 10, 2009
|
