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

NCT ID: NCT02585115

Last Updated: 2016-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

117 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-07-31

Brief Summary

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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

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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.

Conditions

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Urinary Tract Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Symptoms of urinary tract infection

Exclusion Criteria

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

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Pernille Brunsgaard

Medical Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pernille Brunsgaard, med.stud.

Role: PRINCIPAL_INVESTIGATOR

Research Unit of General Practice, Odense

Locations

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Vesterbro Lægehus

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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UCCAREWP4Samples

Identifier Type: -

Identifier Source: org_study_id

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