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

NCT05775614 | Enrolling By Invitation DMC

• 1 other identifier: UROBIQ
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheter Blockage

Keywords

Catheter maintenance; UroTainer; prophylactic; catheter flushing

Outcome Measures

Primary Outcomes (1)

• Number of catheter changes during the treatment and follow-up period.

  Number of catheter changes

  1 year

Secondary Outcomes (8)

• UTI events (Urinary tract infection event)

  1 year

• Urine culture

  1 year

• Odour

  1 year

• Quality of life by SF-36

  1 year

• Quality of life by ICIQ-LTCqol

  1 year

Study Arms (2)

Uro-Tainer® catheter flushing

EXPERIMENTAL

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

Device: UroTainer®

Saline catheter flushing

PLACEBO COMPARATOR

Saline solution catheter flushing two times weekly for 3 months.

Device: Saline

Interventions

UroTainer® DEVICE

Clinical effect of preventive treatment - catheter flushing with UroTainer®

Uro-Tainer® catheter flushing

Saline DEVICE

Clinical effect of preventive treatment - catheter flushing with saline solution

Saline catheter flushing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Study Officials

• Karin Andersen

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 2 arms with randomization 1:1 1. Uro-Tainer® Polihexanide two weekly rinses compared to two weekly rinses with saline for 3 months. 2. Uro-Tainer® with citric acid: Two weekly rinses compared to two weekly rinses with saline for 3 months.

Study Record Dates

• First Submitted: December 17, 2022
• First Posted: March 20, 2023
• Study Start: May 1, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)