Clinical trial NCT05775614: UROtainer for Bladder Catheter Maintenance, Infection Prevention and Quality of Life
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Catheter Blockage
Keywords: Catheter maintenance
UroTainer
prophylactic
catheter flushing
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 arms with randomization 1:1

1. Uro-Tainer® Polihexanide two weekly rinses compared to two weekly rinses with saline for 6 months.
2. Uro-Tainer® with citric acid: Two weekly rinses compared to two weekly rinses with saline for 6 months.
Primary purpose: PREVENTION

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.

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.

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)

Primary outcomes:
measure: Number of catheter changes during the treatment and follow-up period.
timeFrame: 1 year
Secondary outcomes:
measure: UTI events
timeFrame: 1 year
measure: Urine culture
timeFrame: 1 year
measure: Odour
timeFrame: 1 year
measure: Quality of life by SF-36
timeFrame: 1 year
measure: Quality of life by ICIQ-LTCqol
timeFrame: 1 year
measure: Cost effectiveness analyses 1
timeFrame: 1 year
measure: Cost effectiveness analyses 2
timeFrame: 1 year
measure: Cost effectiveness analyses 3
timeFrame: 1 year
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: University of Southern Denmark
name: Karin Andersen
role: PRINCIPAL_INVESTIGATOR
References: