UROtainer for Bladder Catheter Maintenance, Infection Prevention and Quality of Life (NCT05775614) | Clinical Trial Compass
By InvitationNot Applicable
UROtainer for Bladder Catheter Maintenance, Infection Prevention and Quality of Life
Denmark70 participantsStarted 2022-05-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 rel…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of catheter changes during the treatment and follow-up period.