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

June 27, 2006
June 28, 2006
April 4, 2016
July 11, 2017
July 11, 2017
October 2005
May 2011   (Final data collection date for primary outcome measure)
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.
Bladder diary, number of daily incontinence episodes
Complete list of historical versions of study NCT00345332 on Archive Site
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.
Number of pads used, quality-of-life questionnaires
Not Provided
Not Provided
A Multi-Center Trial of Botox for Severe Urge Urinary Incontinence
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial of Botox for Severe Refractory Urge Urinary Incontinence
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.
A multi-center clinical trial of Botulinum-A Toxin (Botox) for refractory urge incontinence.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Urinary Incontinence
  • Drug: Botox
  • Drug: Placebo
  • Placebo Comparator: 1
    Intervention: Drug: Placebo
  • Experimental: 2
    Intervention: Drug: Botox
Flynn MK, Webster GD, Amundsen CL. The effect of botulinum-A toxin on patients with severe urge urinary incontinence. J Urol. 2004 Dec;172(6 Pt 1):2316-20.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2011
May 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
21 Years to 90 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
University of Rochester
University of Rochester
Not Provided
Principal Investigator: Michael K Flynn, MD University of Rochester
University of Rochester
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP