Urinary Tract InfectionsNCT02585115
Diagnostic Accuracy of Point of Care Test of First Voided Urine Compared to Midstream Voided Urine in Primary Care
An observational study of Urinary Tract Infections, run by University of Copenhagen at 1 site in Denmark.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Tract Infections
- How many people
- 117 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2015to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Non-pregnant adult women with symptoms of UTI all included in General Practice.
Who may be able to join
- Symptoms of urinary tract infection
Who cannot join
- Men
- Pregnancy
- Children
- Unable to understand the verbal and written guide
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Urinary Tract Infections
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Difference in accuracy from 0 hours to 4 hours of the POCT Flexicult ID in the most precise of the above techniques.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pernille Brunsgaard, University of Copenhagen
- Investigators
- Pernille Brunsgaard, med.stud., Principal investigator, Research Unit of General Practice, Odense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585115
- Sponsor's protocol ID
- UCCAREWP4Samples
- Status last verified
- Oct 2016
- First submitted
- 5 Oct 2015
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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?
- ClinicalTrials.gov ID
- NCT02585115
- Acronym / sponsor ID
- UCCAREWP4Samples
- Conditions
- Urinary Tract Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 23 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-pregnant adult women with symptoms of UTI all included in General Practice.
Key inclusion criteria (1 listed)
- Symptoms of urinary tract infection
Key exclusion criteria (4 listed)
- Men
- Pregnancy
- Children
- Unable to understand the verbal and written guide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
6 secondary outcomes
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pernille Brunsgaard, med.stud. principal investigator
Research Unit of General Practice, Odense
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2016.