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Catheter BlockageUROBIQNCT05775614

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

A study testing UroTainer® and Saline in people with Catheter Blockage, run by Odense University Hospital at 1 site in Denmark.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Catheter Blockage
What is being tested?
UroTainer® and Saline
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteDenmark
Study dates
1 May 2022to 1 Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Denmark1 site

  • Odense University Hospital

    Odense, 5000

Other trials in Denmark

About this study

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

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.

Read the 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.
Being tested
UroTainer®, Saline
Keywords
Catheter maintenance, UroTainer, prophylactic, catheter flushing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UroTainer®Device

    Clinical effect of preventive treatment - catheter flushing with UroTainer®

  • SalineDevice

    Clinical effect of preventive treatment - catheter flushing with saline solution

Study groups in NCT05775614
Study groupRoleWhat they receive
Uro-Tainer® catheter flushingExperimentalUro-Tainer® catheter flushing two times weekly for 3 months.
Receives: Device: UroTainer®
Saline catheter flushingPlacebo comparatorSaline solution catheter flushing two times weekly for 3 months.
Receives: Device: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Number of catheter changes

    Measured: 1 year

Secondary outcomes (8)

  1. UTI events (Urinary tract infection event)

    The number of prescriptions

    Measured: 1 year

  2. Urine culture

    Urine culture performed if UTI is suspected

    Measured: 1 year

  3. Odour

    Odour nuisance is to be assessed on a 5-point scale. A high score is a worse outcome.

    1. No odour
    2. Discreet odour nuisance after catheter care
    3. Odour that is noticed once in a while. Noticed by the participant and relatives
    4. Odour that is present all the time around the participant
    5. Solid odour that is felt in all rooms. "It hangs" on the participant

    Measured: 1 year

  4. Quality of life by SF-36

    SF-36 (Health Survey Short Form 36)

    The SF-36 consists of 36 items - that are grouped into 8 subscales or domains:

    Physical functioning (10 items); Role limitations due to physical health (4 items); Role limitations due to emotional problems (4 items); Energy/fatigue; Emotional well-being; Social functioning (2 items); Pain (2 items); General health. Aggregate scores for each domain range from 0 to 100, compiled as a percentage - where the higher the score, the more favourable the health state.

    Measured: 1 year

  5. Quality of life by ICIQ-LTCqol

    Living with a long term catheter (ICIQ-LTCqol 12/12 ) The questionnaire consists of three scales yielding two summary measures catheter function and concern score, lifestyle impact and unscored items. Possible scores range from 1 to 530, with lower scores representing better catheter function, concern score and life impact.

    Measured: 1 year

  6. Cost effectiveness analyses 1

    Costs of used catheters in DDK pr participant

    Measured: 1 year

  7. Cost effectiveness analyses 2

    Costs of used solutions for the maintenance of indwelling urethral and suprapubic catheters in DKK pr participant

    Measured: 1 year

  8. Cost effectiveness analyses 3

    Costs of used time of the health care professionals used for catheter maintenance and control in primary care in DKK pr participant

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2023
  2. Study start1 May 2022
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05775614
Sponsor's protocol ID
UROBIQ
Acronym
UROBIQ
Status last verified
Sep 2025
First submitted
17 Dec 2022
Last updated
18 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing UroTainer® and Saline in people with Catheter Blockage, run by Odense University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of catheter changes during the treatment and follow-up period. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05775614.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.

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