Recurrent Urinary Tract Infections and the Microbiome

Is PCR Amplification More Sensitive Than Urine Cultures in Diagnosing Urinary Tract Infections in Patients With Recurrent Bladder Infections?

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04831840

Enrollment

Registered

2021-04-05

Start date

2021-05-26

Completion date

2023-11-20

Last updated

2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Urinary Tract Infection

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results