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?
1 other identifier
observational
117
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 5, 2015
CompletedFirst Posted
Study publicly available on registry
October 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedOctober 6, 2016
October 1, 2016
9 months
October 5, 2015
October 5, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
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
1 year
Difference in accuracy from 0 hours to 4 hours of the POCT Flexicult ID in the most precise of the above techniques.
1 year
Secondary Outcomes (6)
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
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
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
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
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
1 year
- +1 more secondary outcomes
Study Arms (1)
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.
Eligibility Criteria
Non-pregnant adult women with symptoms of UTI all included in General Practice.
You may qualify if:
- Symptoms of urinary tract infection
You may not qualify if:
- Men
- Pregnancy
- Children
- Unable to understand the verbal and written guide
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vesterbro Lægehus
Copenhagen, 1756, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pernille Brunsgaard, med.stud.
Research Unit of General Practice, Odense
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Student
Study Record Dates
First Submitted
October 5, 2015
First Posted
October 23, 2015
Study Start
October 1, 2015
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
October 6, 2016
Record last verified: 2016-10