UROtainer for Bladder Catheter Maintenance, Infection Pre... | NCT05775614

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

NCT05775614

Sponsor

Odense University Hospital

Status

Enrolling by invitation

Last Update Posted

Sep 18, 2025Actual

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Catheter Blockage

Interventions

UroTainer®
Saline

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2022Actual

Primary Completion Date

Jan 1, 2027Estimated

Completion Date

Jan 1, 2028Estimated

First Submitted Date

Dec 17, 2022

First Submission Date that Met QC Criteria

Mar 7, 2023

First Posted Date

Mar 20, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2025

Last Update Posted Date

Sep 18, 2025Actual

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
UroTainer®	Device	Clinical effect of preventive treatment - catheter flushing with UroTainer®	Uro-Tainer® catheter flushing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of catheter changes during the treatment and follow-up period.	Number of catheter changes	1 year

Secondary Outcomes

Measure	Description	Time Frame
UTI events (Urinary tract infection event)	The number of prescriptions	1 year
Urine culture	Urine culture performed if UTI is suspected

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided