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Urinary Tract InfectionNCT00068120

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

An observational study of Urinary Tract Infection, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for
Urinary Tract Infection
How many people
200 participants
Where
1 siteUnited States
Study dates
Start not givento not given
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • Women only
  • Healthy volunteers accepted
  • Adult
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Washington, Hall Health Primary Care Center

    Seattle, Washington, 98195

Other trials in United States

About this study

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.

Read more

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.

Keywords
Urinary tract infection
Medical subject headings
Urinary Tract Infections

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2003 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00068120
Sponsor's protocol ID
ORWHSCOR-dk64540 (compltd)
Status last verified
Jan 2010
First submitted
8 Sep 2003
Last updated
14 Jan 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Urinary Tract Infection, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2010.

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