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

NCT ID: NCT05775614

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2028-01-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Uro-Tainer® catheter flushing

Uro-Tainer® catheter flushing two times weekly for 3 months.

Group Type: EXPERIMENTAL

UroTainer®

Intervention Type: DEVICE

Clinical effect of preventive treatment - catheter flushing with UroTainer®

Saline catheter flushing

Saline solution catheter flushing two times weekly for 3 months.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DEVICE

Clinical effect of preventive treatment - catheter flushing with saline solution

Interventions

UroTainer®

Clinical effect of preventive treatment - catheter flushing with UroTainer®

Intervention Type: DEVICE

Saline

Clinical effect of preventive treatment - catheter flushing with saline solution

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Karin Andersen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karin Andersen

Role: PRINCIPAL_INVESTIGATOR

University of Southern Denmark

Locations

Odense University Hospital

Odense, , Denmark

Countries

Denmark

Other Identifiers

UROBIQ

Identifier Type: -

Identifier Source: org_study_id