Recurrent Urinary Tract Infections and the Microbiome

NCT04831840 | Terminated

• 1 other identifier: 20201198
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Recurrent Urinary Tract Infection

Outcome Measures

Primary Outcomes (2)

• Proportion of uropathogens

  The proportion of uropathogens found on PCR versus urine culture from urine samples.

  Day 1

• Proportion of patients negative for repeat testing

  The proportion of negative patient on repeat testing of urine samples.

  Up to 4 weeks

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients with RUTIs and controls will be enrolled from University of Miami's or Holy Cross Hospital's female pelvic medicine and reconstructive surgery clinics.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (2)

Holy Cross Hospital

Fort Lauderdale, Florida, 33301, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Laura Martin, DO

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 5, 2021
• Study Start: May 26, 2021
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)