Urinary Tract InfectionsNCT03522766
Evaluation of Urine Samples and Their Relation to Urinary Tract Infection
An observational study of Urinary Tract Infections, run by Coloplast A/S at 1 site in Denmark.
Trial summary
The aim is to explore the human urine composition and its relation to urine tract infections Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- urine sample
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Mar 2018to 23 Sep 2019
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of danish subjects and will consist of healthy volunteers as well as users of intermittent catheter (neurogenic bladder or enlarged prostate) with and without reoccurring urine tract infections.
Who may be able to join
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- For the 2 patient populations: Use intermittent catheter on a daily basis due to neurogenic bladder or enlarged prostate and have used IC for at least 2 months
- For healthy volunteers without UTIs: No diag-nosed UTIs within the last year
- For healthy volunteers with recurrent UTIs: 3 or more UTIs within the last year or 2 UTIs within the last 6 months (treated with antibiotics)
Who cannot join
- Be treated for urinary tract infection at time of enrolment
- May not take prophylactic treatment for urinary tract infections (antibiotics only)
Trial locations and contacts
1 site in 1 country.
About this study
The aim is to explore the human urine composition and its relation to urine tract infections
- Conditions
- Urinary Tract Infections
- Being tested
- urine sample
- 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.
urine sampleOther
The subjects are asked to give a maximum of 15 urine samples during the study
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers with no urinary tract infections | people who don't experience urinary tract infections Receives: Other: urine sample | |
| Healthy volunteers with urinary tract infections | people who frequently experience urinary tract infections Receives: Other: urine sample | |
| Intermittent catheter users with neurogenic bladder | Not described Receives: Other: urine sample | |
| Intermittent catheter users with enlarged prostate | Not described Receives: Other: urine sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of bacteria present in the urine
The different bacteria isolated present in the urine will be identified
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 posted11 May 2018
- Study start19 Mar 2018
- Primary completion23 Sep 2019
- Study completion23 Sep 2019
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.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lene F Nielsen, PhD, Principal investigator, Coloplast A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522766
- Sponsor's protocol ID
- CP287
- Status last verified
- Jan 2020
- First submitted
- 1 May 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Urine Samples and Their Relation to Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT03522766
- Acronym / sponsor ID
- CP287
- Conditions
- Urinary Tract Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 23 Sep 2019 (actual)
- Study completion
- 23 Sep 2019 (actual)
- First posted
- 11 May 2018 (actual)
- 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 is to explore the human urine composition and its relation to urine tract infections
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers with no urinary tract infections | – | Other: urine samplepeople who don't experience urinary tract infections |
| Healthy volunteers with urinary tract infections | – | Other: urine samplepeople who frequently experience urinary tract infections |
| Intermittent catheter users with neurogenic bladder | – | Other: urine sample |
| Intermittent catheter users with enlarged prostate | – | Other: urine sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of danish subjects and will consist of healthy volunteers as well as users of intermittent catheter (neurogenic bladder or enlarged prostate) with and without reoccurring urine tract infections.
Key inclusion criteria (5 listed)
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- For the 2 patient populations: Use intermittent catheter on a daily basis due to neurogenic bladder or enlarged prostate and have used IC for at least 2 months
- For healthy volunteers without UTIs: No diag-nosed UTIs within the last year
- For healthy volunteers with recurrent UTIs: 3 or more UTIs within the last year or 2 UTIs within the last 6 months (treated with antibiotics)
Key exclusion criteria (2 listed)
- Be treated for urinary tract infection at time of enrolment
- May not take prophylactic treatment for urinary tract infections (antibiotics only)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urine sampleThe subjects are asked to give a maximum of 15 urine samples during the study | Other | Healthy volunteers with no urinary tract infections, Healthy volunteers with urinary tract infections, Intermittent catheter users with enlarged prostate, Intermittent catheter users with neurogenic bladder |
Primary outcome
Type of bacteria present in the urine
Time frame: 1 year
The different bacteria isolated present in the urine will be identified
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 5 Feb 2020.
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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.
Lene F Nielsen, PhD principal investigator
Coloplast A/S
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 Coloplast A/S 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 5 inclusion and 2 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 5 Feb 2020. 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?
Type of bacteria present in the urine (time frame: 1 year). 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 5 Feb 2020.