An observational study in UTI, sponsored by Coloplast A/S. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Coloplast A/S · Observational
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
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.
Coloplast A/S is the lead sponsor of 150 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults using IC as their primary method for bladder emptying.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Collection of urine samples during UTI episodes and Collection of urine samples during a symptom-free baseline period
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.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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