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Catheter flush breakthrough? new study tests two solutions to stop blockages

NCT ID NCT05775614

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether flushing catheters with special solutions (Uro-Tainer with citric acid or polihexanide) can reduce blockages and infections compared to standard saline. About 70 adults with permanent catheters who have had blockages before will take part. The goal is to see if these flushes cut down on catheter changes, improve quality of life, and save money.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Uro-Tainer polihexanide and Uro-Tainer citric acid solutions
What this could lead to
If it works, this could offer a simple, cost-effective way to prevent catheter blockages and infections, reducing the need for frequent catheter changes.
What could go wrong
This is a small, early-stage study with only 70 participants, so results may not apply to everyone. The solutions might not work better than standard saline, and some people may experience irritation or discomfort.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Odense University Hospital

    Odense, 5000, Denmark

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