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

June 27, 2006
August 2, 2011
October 2005
May 2011   (final data collection date for primary outcome measure)
Bladder diary, number of daily incontinence episodes [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Bladder diary, number of daily incontinence episodes
Complete list of historical versions of study NCT00345332 on ClinicalTrials.gov Archive Site
Number of pads used, quality-of-life questionnaires [ Time Frame: Monthly ] [ Designated as safety issue: No ]
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Urinary Incontinence
  • Drug: Botox
    Injected
  • Drug: Placebo
    Injected
  • Placebo Comparator: 1
    Placebo
    Intervention: Drug: Placebo
  • Experimental: 2
    Botox
    Intervention: Drug: Botox
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
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 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
Female
21 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00345332
12299
Yes
Michael K. Flynn, MD, University of Rochester
University of Rochester
Not Provided
Principal Investigator: Michael K Flynn, MD University of Rochester
University of Rochester
September 2010

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