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Vaccine for Recurrent Urinary Tract Infections in Women

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00261248
First received: November 30, 2005
Last updated: NA
Last verified: September 2003
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Recurrent Urinary Tract Infections in Women
 Biological: Immunization with inactivated bacteria
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Phase 2 Clinical Trial of Vaginal Mucosal Immunization for Recurrent Urinary Tract Infections

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Rate of re-infection over the study

Secondary Outcome Measures:
  • Infection-free status at completion of study

Estimated Enrollment: 75
Study Start Date: November 1996
Estimated Study Completion Date: December 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00261248

Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Institutes of Health (NIH)
Investigators
Principal Investigator: David T Uehling, M.D. University of Wisconsin, Madison
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00261248     History of Changes
Other Study ID Numbers: 1996-295, DK-30808
Study First Received: November 30, 2005
Last Updated: November 30, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:
Phase 2
Vaccine
Urinary Tract Infection
Vaginal Mucosal

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on May 22, 2013