Vaccine for Recurrent Urinary Tract Infections in Women
Primary Purpose
Recurrent Urinary Tract Infections in Women
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Immunization with inactivated bacteria
Sponsored by
About this trial
This is an interventional prevention trial for Recurrent Urinary Tract Infections in Women focused on measuring Phase 2, Vaccine, Urinary Tract Infection, Vaginal Mucosal
Eligibility Criteria
Inclusion Criteria: Three or more urinary tract infections in the previous year Exclusion Criteria: Neurogenic bladder Interstitial cystitis Urinary diversion Kidney stones Indwelling catheter
Sites / Locations
- University of Wisconsin Hospital and Clinics
Outcomes
Primary Outcome Measures
Rate of re-infection over the study
Secondary Outcome Measures
Infection-free status at completion of study
Full Information
NCT ID
NCT00261248
First Posted
November 30, 2005
Last Updated
October 1, 2015
Sponsor
University of Wisconsin, Madison
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT00261248
Brief Title
Vaccine for Recurrent Urinary Tract Infections in Women
Official Title
Phase 2 Clinical Trial of Vaginal Mucosal Immunization for Recurrent Urinary Tract Infections
Study Type
Interventional
2. Study Status
Record Verification Date
September 2003
Overall Recruitment Status
Completed
Study Start Date
November 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institutes of Health (NIH)
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is determine whether a vaginal mucosal vaccine given to women with a history of recurrent urinary tract infections can reduce the number of infections occurring in a six-month study period, as compared to placebo treatment.
Detailed Description
Recurrent urinary tract infections (UTIs) affect approximately 10% of women in the United States. Since antibiotic prophylaxis is not always effective, alternate treatments need to be developed. One such treatment would be immunization with a vaccine containing bacteria known to cause these infections. The objective of the study is to immunize susceptible women with inactivated bacteria contained in a vaginal suppository and to monitor the rates of reinfection compared to a group of women treated with placebo suppositories. Each group of patients will receive a total of six suppositories in the first four-months of the six-month study during which all UTIs and side effects will be recorded. The infection rates between vaccine- and placebo-treated women will be statistically analyzed to determine vaccine efficacy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Urinary Tract Infections in Women
Keywords
Phase 2, Vaccine, Urinary Tract Infection, Vaginal Mucosal
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
75 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Immunization with inactivated bacteria
Primary Outcome Measure Information:
Title
Rate of re-infection over the study
Secondary Outcome Measure Information:
Title
Infection-free status at completion of study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Three or more urinary tract infections in the previous year
Exclusion Criteria:
Neurogenic bladder
Interstitial cystitis
Urinary diversion
Kidney stones
Indwelling catheter
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David T Uehling, M.D.
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11171022
Citation
Uehling DT, Hopkins WJ, Beierle LM, Kryger JV, Heisey DM. Vaginal mucosal immunization for recurrent urinary tract infection: extended phase II clinical trial. J Infect Dis. 2001 Mar 1;183 Suppl 1:S81-3. doi: 10.1086/318839. No abstract available.
Results Reference
background
Learn more about this trial
Vaccine for Recurrent Urinary Tract Infections in Women
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