Vaccine for Recurrent Urinary Tract Infections in Women

This study has been completed.
Sponsor:
Collaborator:
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:


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
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 April 17, 2014