Vaccine for Recurrent Urinary Tract Infections in Women

October 1, 2015 updated by: University of Wisconsin, Madison

Phase 2 Clinical Trial of Vaginal Mucosal Immunization for Recurrent Urinary Tract Infections

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Three or more urinary tract infections in the previous year

Exclusion Criteria:

  • Neurogenic bladder
  • Interstitial cystitis
  • Urinary diversion
  • Kidney stones
  • Indwelling catheter

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Rate of re-infection over the study

Secondary Outcome Measures

Outcome Measure
Infection-free status at completion of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: David T Uehling, M.D., University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1996

Study Completion

December 1, 2003

Study Registration Dates

First Submitted

November 30, 2005

First Submitted That Met QC Criteria

November 30, 2005

First Posted (Estimate)

December 2, 2005

Study Record Updates

Last Update Posted (Estimate)

October 5, 2015

Last Update Submitted That Met QC Criteria

October 1, 2015

Last Verified

September 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1996-295
  • DK-30808

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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