A Multi-Center Trial of Botox for Severe Urge Urinary Incontinence

This study has been completed.

First Received on June 27, 2006. Last Updated on August 2, 2011 History of Changes

Sponsor:	University of Rochester
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00345332

Purpose

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.

Condition	Intervention
Urinary Incontinence	Drug: Botox Drug: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial of Botox for Severe Refractory Urge Urinary Incontinence

Resource links provided by NLM:

MedlinePlus related topics: Botox Urinary Incontinence Urine and Urination

Drug Information available for: Botulinum toxin A

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:

Bladder diary, number of daily incontinence episodes [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of pads used, quality-of-life questionnaires [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	October 2005
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Placebo	Drug: Placebo Injected
Experimental: 2 Botox	Drug: Botox Injected

Eligibility

Ages Eligible for Study:	21 Years to 90 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345332

Locations

United States, California
University of California at Davis
Sacramento, California, United States, 95817
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

University of Rochester

Investigators

Principal Investigator:

Michael K Flynn, MD

University of Rochester

More Information

No publications provided

Responsible Party:	Michael K. Flynn, MD, University of Rochester
ClinicalTrials.gov Identifier:	NCT00345332 History of Changes
Other Study ID Numbers:	12299
Study First Received:	June 27, 2006
Last Updated:	August 2, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Urinary Incontinence
Urinary Incontinence, Urge
Urination Disorders

Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012