Recurrent Urinary Tract Infections and the Microbiome

NCT ID: NCT04831840

Last Updated: 2024-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-26

Study Completion Date

2023-11-20

Brief Summary

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The primary objective is to determine if polymerase chain reaction (PCR) (UTIP™) is more sensitive in identifying urinary tract infections (UTI's) than standard urine cultures.

Detailed Description

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Conditions

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Recurrent Urinary Tract Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Female participants with recurrent urinary tract infections (RUTI).

Patients with RUTIs (Group A) will provide two urine samples. One urine sample is a clean catch and the other is a catheterized specimen. Both will be sent for analysis. A perineal swab will also be collect and analyzed for each patient.

No interventions assigned to this group

Female control patients without RUTIs

Patients without RUTIs (Group B) will provide two urine samples. One urine sample is a clean catch and the other is a catheterized specimen. Both will be sent for analysis. A perineal swab will also be collect and analyzed for each patient.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 18 y/o-90 y/o
* Able to consent
* Female
* Group A only: Recurrent UTI (2 UTIs in 6 months)
* Group B only: No history of recurrent UTIs

Exclusion Criteria

* Pregnant
* Pelvic radiation
* Urinary retention (\>200 ml residual)
* Greater than Stage 2 prolapse
* Renal calculi
* Immunosuppressed
* Neurologic disorder with significant bladder impairment
* No current UTI via dip stick
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Laura Martin

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laura Martin, DO

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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Holy Cross Hospital

Fort Lauderdale, Florida, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20201198

Identifier Type: -

Identifier Source: org_study_id

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