Clinical trial NCT02585115: Diagnostic Accuracy of Point of Care Test of First Voided Urine Compared to Midstream Voided Urine in Primary Care
Official title: 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?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infections
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2015-10-23
Enrollment: 117
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-pregnant adult women with symptoms of UTI all included in General Practice.

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.

Eligibility criteria: Inclusion Criteria:

* Symptoms of urinary tract infection

Exclusion Criteria:

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

Primary outcomes:
measure: 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
timeFrame: 1 year
measure: Difference in accuracy from 0 hours to 4 hours of the POCT Flexicult ID in the most precise of the above techniques.
timeFrame: 1 year
Secondary outcomes:
measure: 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
timeFrame: 1 year
measure: Proportion of false-positive cultures after 0 hours at room temperature with first-void urine compared to mid-stream urine when using microscopy
timeFrame: 1 year
measure: 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
timeFrame: 1 year
measure: Proportion of false-positive cultures after 1 hours at room temperature with first-void urine compared to mid-stream urine when using microscopy
timeFrame: 1 year
measure: 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
timeFrame: 1 year
measure: Proportion of false-positive cultures after 4 hours at room temperature with first-void urine compared to mid-stream urine when using microscopy
timeFrame: 1 year
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Vesterbro Lægehus
Study officials:
affiliation: Research Unit of General Practice, Odense
name: Pernille Brunsgaard, med.stud.
role: PRINCIPAL_INVESTIGATOR
References: