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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00345332
Recruitment Status : Completed
First Posted : June 28, 2006
Results First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Information provided by (Responsible Party):
University of Rochester

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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Drug: Botox Drug: Placebo Not Applicable

Detailed Description:
A multi-center clinical trial of Botulinum-A Toxin (Botox) for refractory urge incontinence.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : October 2005
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1
Drug: Placebo
Experimental: 2
Drug: Botox

Primary Outcome Measures :
  1. Incontinent Episodes Per Day [ Time Frame: week 13 ]
    The number of incontinence episodes per day was recorded by each participant in a diary. All incontinence episodes were counted when calculating episodes per day at each time point.

Secondary Outcome Measures :
  1. Number of Incontinence Pads Used Per Day [ Time Frame: week 13 ]
    The number of incontinence pads used per day per day was recorded by each participant in a diary.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00345332

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
Principal Investigator: Michael K Flynn, MD University of Rochester

Publications of Results:
Responsible Party: University of Rochester Identifier: NCT00345332     History of Changes
Other Study ID Numbers: 12299
First Posted: June 28, 2006    Key Record Dates
Results First Posted: July 11, 2017
Last Update Posted: July 11, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents