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

Catheter Blockage Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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.

This randomised study will be performed in two phases: a pilot and the main study.

There is a need for a randomised study to justify if Uro-Tainer® flushing will have an advantage instead of 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-time catheter maintenance.

Pilot study:

Uro-Tainer® Polihexanide twice a week for 12 weeks and compared to saline flushing in the same regime.

Main study:

• Uro-Tainer® Polihexanide two weekly rinses compared to two weekly rinses with saline for 6 months.

• Uro-Tainer® with citric acid: Two weekly rinses compared to two weekly rinses with saline for 6 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. ;

Related Conditions & MeSH terms

• Catheter Blockage

• NCT number: NCT05775614
• Study type: Interventional
• Source: Odense University Hospital
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 1, 2022
• Completion date: January 1, 2026