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

This study has been completed.
Sponsor:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00345332
First received: June 27, 2006
Last updated: August 2, 2011
Last verified: September 2010
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014