NCT02585115

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
• Phase: —
• Study type: Observational
• Enrollment: 117 (actual)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Tract Infections

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-10-23
• Last updated: 2016-10-06

Locations

1 site across 1 country: Denmark