ORWH:SCOR - Sex/Gender Factors Affecting Women's Health

January 12, 2010 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

This project is the clinical project of a Specialized Center of Research (SCOR) proposal which is designed to further our understanding of urinary tract infection (UTI) in women. Acute uncomplicated urinary tract infections (UTIs) occur in an estimated 7-11 million women each year, and the annual costs of caring for these women are thought to approach $1.6 billion. Approximately 20-30% of women suffer from frequent recurrent infections. UTIs in young women result in substantial symptoms, time lost from work, and medical costs. An improved understanding of the mechanisms underlying UTIs could result in new approaches to their prevention and reduced numbers of women with infections and the amount of antibiotics use.

In this project we seek a better understanding of the causes of UTI. Most experts believe that vaginal colonization with UTI-causing bacteria from the rectal flora precedes colonization of the urethra (the tube from the bladder for urination) and bladder and subsequent UTI, but the relationships between these events has not been established. Moreover, recent information from studies in mice strongly suggest that persistent bladder infection follows an initial bladder infection.

In this project, we will prospectively follow a large group of women with recurrent UTI to determine: 1) the relationships in time between vaginal colonization with a UTI-causing bacteriuria, asymptomatic bacteriuria (bacteria in the bladder but without any UTI symptoms) and symptomatic UTI, and 2) the presence of persistent bacteria in the bladder following the symptomatic UTI at entry into the study and whether such bacteria are related to later UTIs that are caused by the same bacteria that caused the UTI at entry into the study. We will thus be able to determine the relative importance of vaginal colonization vs. persistent infection of the bladder as the origin of the bacteria causing recurrent UTI.

UTI-causing bacteria cultured from women with symptomatic UTI and asymptomatic bacteriuria will undergo studies by Dr. Scott Hultgren's group at Washington University in Project 1 to identify unique genes that may help us understand why some bacteria cause symptoms and others do not. The effect of bacteria causing UTI in these women on host response will also be determined by studies by Dr. Jeff Gordon's laboratory at Washington University in Project 3.

A better understanding of the molecular and epidemiologic basis of UTI is critical in developing the best possible prevention and management strategies.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

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
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington, Hall Health Primary Care Center

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 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

  • Healthy women with bladder infection who have a history of at least one previous UTI in the past 12 months.
  • Women must be able to provide written informed consent.
  • They must not be pregnant or planning on becoming pregnant in the next 3 months, have no chronic illness, have no known anatomic or functional abnormalities of the urinary tract and not have any symptoms suggestive of kidney infection.

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

  • Time Perspectives: Prospective

Collaborators and Investigators

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

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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 Registration Dates

First Submitted

September 8, 2003

First Submitted That Met QC Criteria

September 8, 2003

First Posted (Estimate)

September 9, 2003

Study Record Updates

Last Update Posted (Estimate)

January 14, 2010

Last Update Submitted That Met QC Criteria

January 12, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORWHSCOR-dk64540 (compltd)

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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