Urine Sample Biobank for Adults Using Intermittent Catheters

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, non-interventional study that collects urine samples from adult intermittent catheter users who have had recent UTIs and those who have not. Samples will be stored in a research biobank for up to five years after the last patient out, with each participant contributing up to one year of samples or until four complete collections are obtained. Urine collection is done at home or via pickup and does not involve any new medical procedures or devices. Participants complete questionnaires related to UTI episodes and baseline collection. No investigational devices are tested, and standard care remains unchanged throughout the study.

Why it matters

Who can join: the full rules

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

Where it's running

• Coloplast research facility
  Humlebæk, Denmark Recruiting

Study contacts

• Study coordinator: Mette Krogh
• Email: dkmekr@coloplast.com
• Phone: +4549113245

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.