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

October 5, 2016 updated by: Pernille Brunsgaard, University of Copenhagen

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?

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

117

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 1756
        • Vesterbro Lægehus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Symptoms of urinary tract infection

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 1 year
1 year
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
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: 1 year
1 year
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
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
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Investigators

  • Principal Investigator: Pernille Brunsgaard, med.stud., Research Unit of General Practice, Odense

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

October 5, 2015

First Submitted That Met QC Criteria

October 21, 2015

First Posted (Estimate)

October 23, 2015

Study Record Updates

Last Update Posted (Estimate)

October 6, 2016

Last Update Submitted That Met QC Criteria

October 5, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCCAREWP4Samples

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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