Urine Research Biobank
ConditionUTI
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorColoplast A/S
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 population
Adults using IC as their primary method for bladder emptying.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
urinesample collection
Other interventionCollection of urine samples during UTI episodes and Collection of urine samples during a symptom-free baseline period
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov