ClinicalTrials.gg
CompletedNCT02585115Updated Oct 6, 2016

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

An observational study in Urinary Tract Infections, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-06.

Sponsored by University of Copenhagen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
117
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Urinary Tract Infections
03

In context

Urinary Tract Infections

779 studies on the registry are indexed under Urinary Tract Infections; 132 are open to participants now.

This study's enrollment of 117 is below the median of 200 across 193 observational studies indexed under Urinary Tract Infections.

Browse Urinary Tract Infections studies →

Lead sponsor

University of Copenhagen is the lead sponsor of 465 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Non-pregnant adult women with symptoms of UTI all included in General Practice.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Symptoms of urinary tract infection

Exclusion criteria

Exclusion Criteria:

  • Men
  • Pregnancy
  • Children
  • Unable to understand the verbal and written guide
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
117 participants (actual)
Patient registry
No

Groups and cohorts

  • Non-pregnant women with symptoms

    Non-pregnant women with one or more symptoms of UTI. All women will make a paired urine sample (first void and midstream void) of the same urine sample.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 year

  2. Difference in accuracy from 0 hours to 4 hours of the POCT Flexicult ID in the most precise of the above techniques.

    Time frame: 1 year

Secondary outcomes

  1. 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

    Time frame: 1 year

  2. Proportion of false-positive cultures after 0 hours at room temperature with first-void urine compared to mid-stream urine when using microscopy

    Time frame: 1 year

  3. 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

    Time frame: 1 year

  4. Proportion of false-positive cultures after 1 hours at room temperature with first-void urine compared to mid-stream urine when using microscopy

    Time frame: 1 year

  5. 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

    Time frame: 1 year

  6. Proportion of false-positive cultures after 4 hours at room temperature with first-void urine compared to mid-stream urine when using microscopy

    Time frame: 1 year

07

Study locations

1 site
  • Vesterbro Lægehus
    Copenhagen, 1756, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02585115
Responsible party
Pernille Brunsgaard (Medical Student, University of Copenhagen) — Principal investigator
First posted
Oct 23, 2015
Start date
Oct 2015
Primary completion
Jul 2016
Completion
Jul 2016
Last update
Oct 6, 2016

Study contacts

Pernille Brunsgaard, med.stud.
principal investigator · Research Unit of General Practice, Odense

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion