UTI
Conditions
Brief 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
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.
Interventions
OTHERurinesample collection
Collection of urine samples during UTI episodes and Collection of urine samples during a symptom-free baseline period
Sponsors
Coloplast A/S
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 4 collections of UTI and Baseline urine samples or participation from enrollemnt and 1 year. |
Countries
Denmark
Contacts
CONTACTMette Krogh
Outcome results
None listed