Diagnostic Accuracy of Point of Care Test of First Voided Urine Compared to Midstream Voided Urine in Primary Care

Is a First Void Urine Sample as Accurate as a Midstream Urine Sample in Diagnosing Urinary Tract Infections With a Point-Of-Care-Test Method in Adult, Symptomatic, Non-pregnant Women in General Practice?

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02585115

Enrollment

117

Registered

2015-10-23

Start date

2015-10-31

Completion date

2016-07-31

Last updated

2016-10-06

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

Conditions

Urinary Tract Infections

Brief summary

The aim of this study is to determine if sampling technique of urine affects diagnostic modalities in primary care. Furthermore it aims to determine if there is difference in the accuracy of the point-of-care test, when the urine sample is stored at room-temperature and analyzed later in the day.

Detailed description

125 patients with one or more symptoms of urinary tract infections, contacting their GP, are asked to make 2 urine samples from the same void. The patient is asked to void firstly in one cup, approximately 10-20 ml., then stop voiding. Then the patient is asked to void the rest into a second cup. This way there is collected both a first-void and a midstream-void from the same patient and the same void. All the samples are analyzes using urine-dipstick, microscopy and point of care test urine culture. The urine of the midstream void is sent to a Microbiology lab for analyzes as well. Furthermore the test are analyzes again after 1 and 4 hours.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Symptoms of urinary tract infection

Exclusion criteria

* Men * Pregnancy * Children * Unable to understand the verbal and written guide

Design outcomes

Primary

Measure	Time frame
Difference in accuracy of POC urine culture on first-void urine compared to mid-stream urine wtih mid-stream urine microbiological culture as a reference	1 year
Difference in accuracy from 0 hours to 4 hours of the POCT Flexicult ID in the most precise of the above techniques.	1 year

Secondary

Measure	Time frame
Proportion of false-positive cultures after 1 hours at room temperature with first-void urine compared to mid-stream urine when using a urin-dipstick	1 year
Proportion of false-positive cultures after 1 hours at room temperature with first-void urine compared to mid-stream urine when using microscopy	1 year
Proportion of false-positive cultures after 0 hours at room temperature with first-void urine compared to mid-stream urine when using a urin-dipstick	1 year
Proportion of false-positive cultures after 4 hours at room temperature with first-void urine compared to mid-stream urine when using microscopy	1 year
Proportion of false-positive cultures after 4 hours at room temperature with first-void urine compared to mid-stream urine when using a urin-dipstick	1 year
Proportion of false-positive cultures after 0 hours at room temperature with first-void urine compared to mid-stream urine when using microscopy	1 year

Countries

Denmark

Outcome results