Vaccine for Recurrent Urinary Tract Infections in Women - Full Text View

Sponsors and Collaborators:	University of Wisconsin, Madison National Institutes of Health (NIH)
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00261248

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 II

MedlinePlus related topics: Urinary Tract Infections

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 2 Clinical Trial of Vaginal Mucosal Immunization for Recurrent Urinary Tract Infections

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:

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. No abstract available.

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

Keywords provided by University of Wisconsin, Madison:

Phase 2
Vaccine
Urinary Tract Infection
Vaginal Mucosal

Study placed in the following topic categories:

Urologic Diseases
Urinary Tract Infections
Recurrence

Additional relevant MeSH terms:

Communicable Diseases
Disease Attributes
Pathologic Processes
Infection

ClinicalTrials.gov processed this record on January 14, 2009