UroTainer®: Clinical effect of preventive treatment - catheter flushing with UroTainer®
Saline: Clinical effect of preventive treatment - catheter flushing with saline solution
Study summary
The purpose of the current study is to investigate whether catheter flushing with Uro-Tainer® with citric acid and Uro-Tainer® Polihexanide can: Reduce catheter changes due to incrustation and blockage.
In addition, a list of secondary aims inclusive of cost-effectiveness analysis in collaboration with the Centre for Innovative Medical Technology (CIMT) at OUH.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
Citizen not previously flushed
* A permanent catheter (suprapubic and urethral)
* Male and female \> 18 years of age
* Acute or previous catheter stop because of blocking or incrustations.
* The pilot project does not include clogging due to incrustations
* Voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Ethics Committee (EC) before all evaluations.
Citizen previously flushed with NaCl or UroTainer®
* A permanent catheter (suprapubic and urethral)
* Male and female \> 18 years of age
* Willingness to take a rinse break for a minimum of 4 weeks. In the event of 2 catheter stops during the flushing break, assessed on the basis of an urgent need for catheter flushing with NaCl or catheter change, the citizen can be included.
* The pilot project does not include clogging due to incrustations
* If there is no catheter stop during the rinsing break, the citizen will continue without rinsing until a possible catheter stop.
* Voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Ethics Committee (EC) before all evaluations.
Exclusion Criteria:
* Urothelial cancer
* Bladder and kidney stones requiring treatment
* Age \< 18 years of age
* Pregnant and / or breastfeeding women
* Not able to understand Danish
* Dementia, where relatives can / will not give consent
* Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)
Primary outcome measure(s)
Number of catheter changes during the treatment and follow-up period. — 1 year Number of catheter changes
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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