Back to resultsA Multi-Center Trial of Botox for Severe Urge Urinary Incontinence
Primary Purpose
Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Botox
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence
Eligibility Criteria
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
Sites / Locations
- University of California at Davis
- Beth Israel Deaconess Medical Center
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
1
2
Arm Description
Placebo
Botox
Outcomes
Primary Outcome Measures
Incontinent Episodes Per Day
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
Number of Incontinence Pads Used Per Day
The number of incontinence pads used per day per day was recorded by each participant in a diary.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00345332
Brief Title
A Multi-Center Trial of Botox for Severe Urge Urinary Incontinence
Official Title
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial of Botox for Severe Refractory Urge Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Rochester
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
A multi-center clinical trial of Botulinum-A Toxin (Botox) for refractory urge incontinence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
2
Arm Type
Experimental
Arm Description
Botox
Intervention Type
Drug
Intervention Name(s)
Botox
Intervention Description
Injected
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Injected
Primary Outcome Measure Information:
Title
Incontinent Episodes Per Day
Description
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.
Time Frame
week 13
Secondary Outcome Measure Information:
Title
Number of Incontinence Pads Used Per Day
Description
The number of incontinence pads used per day per day was recorded by each participant in a diary.
Time Frame
week 13
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael K Flynn, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California at Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15538257
Citation
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. doi: 10.1097/01.ju.0000143889.00681.3f.
Results Reference
result
Learn more about this trial
A Multi-Center Trial of Botox for Severe Urge Urinary Incontinence
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