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Can a smarter catheter cut infection risk?

NCT ID NCT06474845

Disease control Sponsor: Rethink Medical SL Source: ClinicalTrials.gov ↗

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This trial compares a new urinary catheter, called T-Control, with the standard Foley catheter in adults who need long-term catheterization for at least four weeks. Researchers want to see whether the T-Control design reduces urinary tract infections and improves quality of life. Participants will use one of the two catheters, keep a symptom diary, and return for checkups and questionnaires after four weeks.

What this could mean

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

Active substance
T-Control catheter, a new urinary catheter design
What this could lead to
If it works, the T-Control catheter could lower infection rates and improve daily comfort for people who need long-term urinary catheters.
What could go wrong
This is a small early-stage study with only 12 participants, so results may not apply broadly. The new catheter could also cause its own complications, such as blockage 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

12 people

The number who actually took part.

Started

Feb 2024

Finished

Sep 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Men or women aged ≥18 years * Patients who require change of bladder catheter. * Patients with indication of bladder catheterization for at least 4 weeks. * Patients who maintain cognitive and physical ability for self-monitoring of the catheter valve. * Patients who sign ICF prior to the performance of any study-specific procedure. Exclusion Criteria: * Use of current antibiotic treatment or in the 2 weeks prior to the study inclusion. * Patients undergoing chemotherapy, radiotherapy, immunosuppressants or retroviral treatment. * Patients with bilateral obstructive supravesical uropathy. * Inability to read and understand the language of the Hospital's country. * Patients who are participating in a clinical trial or intends to participate during the course of this study.

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Conditions

The condition(s) this trial relates to.

Infections

As listed by the trial registrant

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

Catheter related complication Catheter; infection (indwelling catheter) Quality of life

Contacts and locations

Locations

  • Egas Moniz Hospital

    Lisbon, 1349-019, Portugal

  • La Fe University and Polytechnic Hospital

    Valencia, Valencia, 46026, Spain

  • Prof. Doutor Fernando Fonseca Hospital

    Amadora, 2720-276, Portugal

  • Regional University Hospital of Malaga

    Málaga, Andalucía/Spain, 29010, Spain

  • Rey Juan Carlos University Hospital

    Móstoles, Madrid/Spain, 28933, Spain

  • Unidade Local de Saúde de Santa Maria - Centro de Investigação Clínica

    Lisbon, 1649-028, Portugal

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