UTINCT07769606
Urine Research Biobank
An observational study of UTI, run by Coloplast A/S at 1 site in Denmark.
Trial summary
This is an non-interventional exploratory study collecting urine samples from adult intermittent catheter users with and without UTIs. No investigational device is tested, and subjects' standard care remains unchanged. Urine samples will be stored in a research biobank until completion of the project Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- UTI
- What is being tested?
- urinesample collection
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Aug 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Adults using IC as their primary method for bladder emptying.
Who may be able to join
- Has given written informed consent
- Is at least 18 years old
- Has full legal capacity
- Is able (assessed by investigator) and willing to adhere to study procedures during study duration.
- Has used Intermittent Catheterization (IC) as primary method for bladder emptying for at least a year at time of enrolment.
- Has had at least 2 but fewer than 6 self-reported or clinically confirmed Urinary tract Infections in the last year prior to inclusion
Who cannot join
- Is participating or plan to participate in any other clinical study with direct relation to the lower urinary tract
- Has previously participated in this study
- Is currently using prophylactic antibiotic
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Coloplast research facility
Humlebæk, 3050
Lene Feldskov Nielsen, +4549111888, dklfn@coloplast.com
About this study
Official title: Establishment of a Urine Research Biobank to Explore Basic Urine Characteristics From Adult Intermittent Catheter Users
This is an non-interventional exploratory study collecting urine samples from adult intermittent catheter users with and without UTIs. No investigational device is tested, and subjects' standard care remains unchanged. Urine samples will be stored in a research biobank until completion of the project
Read the detailed description
This is a prospective non-interventional, exploratory study designed to collect urine samples from adult users of IC with and without UTIs. No investigational device is being tested, and no changes to standard care are introduced.
All urine samples collected will be stored in the research biobank for no longer than 5 years after last patient out (LPO).The total duration for each subject will be approximately one year from V1 or until subject have 4 full urine sample collections. During this period, urine samples will be collected by the subject at home, picked up from their residence, and transported to the research site. Subjects are required to complete a questionnaire in connection with both UTI episodes- and the baseline sample collection.
- Conditions
- UTI
- Being tested
- urinesample collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urinesample collectionOther
Collection of urine samples during UTI episodes and Collection of urine samples during a symptom-free baseline period
What is being measured
The primary outcome is the main question the study is designed to answer.
Total bacterial count from the 1st urine sample collected the day that the subject experienced symptoms of a UTI and the mean total bacterial count based on up to 3 samples from corresponding baseline
Measured: 4 collections of UTI and Baseline urine samples or participation from enrollemnt and 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start14 Aug 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UTIStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769606
- Sponsor's protocol ID
- CP388
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 18 Aug 2026
- 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 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Urine Research Biobank to Explore Basic Urine Characteristics From Adult Intermittent Catheter Users
- ClinicalTrials.gov ID
- NCT07769606
- Acronym / sponsor ID
- CP388
- Conditions
- UTI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Aug 2026 (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.
This is an non-interventional exploratory study collecting urine samples from adult intermittent catheter users with and without UTIs. No investigational device is tested, and subjects' standard care remains unchanged. Urine samples will be stored in a research biobank until completion of the project
Detailed description
This is a prospective non-interventional, exploratory study designed to collect urine samples from adult users of IC with and without UTIs. No investigational device is being tested, and no changes to standard care are introduced.
All urine samples collected will be stored in the research biobank for no longer than 5 years after last patient out (LPO).The total duration for each subject will be approximately one year from V1 or until subject have 4 full urine sample collections. During this period, urine samples will be collected by the subject at home, picked up from their residence, and transported to the research site. Subjects are required to complete a questionnaire in connection with both UTI episodes- and the baseline sample collection.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults using IC as their primary method for bladder emptying.
Key inclusion criteria (6 listed)
- Has given written informed consent
- Is at least 18 years old
- Has full legal capacity
- Is able (assessed by investigator) and willing to adhere to study procedures during study duration.
- Has used Intermittent Catheterization (IC) as primary method for bladder emptying for at least a year at time of enrolment.
Key exclusion criteria (3 listed)
- Is participating or plan to participate in any other clinical study with direct relation to the lower urinary tract
- Has previously participated in this study
- Is currently using prophylactic antibiotic
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 |
|---|---|---|
| urinesample collectionCollection of urine samples during UTI episodes and Collection of urine samples during a symptom-free baseline period | Other | – |
Primary outcome
Total bacterial count from the 1st urine sample collected the day that the subject experienced symptoms of a UTI and the mean total bacterial count based on up to 3 samples from corresponding baseline
Time frame: 4 collections of UTI and Baseline urine samples or participation from enrollemnt and 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
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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.
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 UTI, 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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 18 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mette Krogh (+4549113245, dkmekr@coloplast.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total bacterial count from the 1st urine sample collected the day that the subject experienced symptoms of a UTI and the mean total bacterial count based on up to 3 samples from corresponding baseline (time frame: 4 collections of UTI and Baseline urine samples or participation from enrollemnt and 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 18 Aug 2026.