Vaccine for Recurrent Urinary Tract Infections in Women

This study has been completed.
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: November 30, 2005
Last updated: October 1, 2015
Last verified: September 2003
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.

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00261248

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)
Principal Investigator: David T Uehling, M.D. University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison Identifier: NCT00261248     History of Changes
Other Study ID Numbers: 1996-295, DK-30808
Study First Received: November 30, 2005
Last Updated: October 1, 2015
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Communicable Diseases
Urinary Tract Infections
Urologic Diseases processed this record on November 27, 2015