Recurrent Urinary Tract Infections and the Microbiome

Terminated

• Conditions: Recurrent Urinary Tract Infection

• Registration Number: NCT04831840
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-02
• Study First Submitted QC: 2021-04-02
• Study First Posted: 2021-04-05
• Study Start: 2021-05-26
• Primary Completion: 2023-11-20
• Study Completion: 2023-11-20
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-18
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 32

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients negative for repeat testing	Up to 4 weeks	The proportion of negative patient on repeat testing of urine samples.
Proportion of uropathogens	Day 1	The proportion of uropathogens found on PCR versus urine culture from urine samples.

Trial Locations

Locations (2)

Holy Cross Hospital; 🇺🇸 Fort Lauderdale, Florida, United States

University of Miami; 🇺🇸 Miami, Florida, United States