NCT05775614

UROtainer for Bladder Catheter Maintenance, Infection Prevention and Quality of Life

Study of Uro-Tainer® Polihexanide and Uro-Tainer® With Citric Acid on Catheter Blockage, Infection Prevention, Cost-effectiveness and Quality of Life (UROBIQ): a Prospective Randomized Single-blinded Clinical Study

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. There is a need for a randomised study to justify if Uro-Tainer® flushing will have an advantage over the cheaper and normally used Saline flushing. Standard therapies vary depending on the blockage type and severity. Saline Solution can be used daily for a shorter period and 1-2 times a week for long-term catheter maintenance. Study: * Uro-Tainer® Polihexanide two weekly rinses compared to two weekly rinses with saline for 3 months. * Uro-Tainer® with citric acid: Two weekly rinses compared to two weekly rinses with saline for 3 months. Clinical benefits: * Less catheter blockage -\> less need for catheter replacement outside the regular schedule -\> Fewer infections and better QoL * It is expected that cost-effectiveness analysis will show a better economic outcome for the society * No unknown adverse effects are expected * The risk of participation in this study is very small compared to the expected effect of fewer catheter replacements, fewer infections and better QoL which justifies the selection of clinical endpoints.

Conditions

• Catheter Blockage

Interventions

Type	Name	Description
DEVICE	UroTainer®	Clinical effect of preventive treatment - catheter flushing with UroTainer®
DEVICE	Saline	Clinical effect of preventive treatment - catheter flushing with saline solution

Timeline

• Start date: 2022-05-01
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2023-03-20
• Last updated: 2025-09-18

Locations

1 site across 1 country: Denmark