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Clinical Trials/NCT04831840
NCT04831840TerminatedNot Applicable

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

University of Miami2 sites in 1 country32 target enrollmentStarted: May 26, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
32
Locations
2
Primary Endpoint
Proportion of patients negative for repeat testing
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Proportion of patients negative for repeat testing

Time Frame: Up to 4 weeks

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

Proportion of uropathogens

Time Frame: Day 1

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Laura Martin

Assistant Professor

University of Miami

Study Sites (2)

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