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Can a redesigned catheter make long-term bladder care less of a burden?

NCT ID NCT05860231

Symptom relief 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 study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 pilot study tests whether a new catheter called T-Control improves comfort, quality of life, and infection rates compared with the standard Foley catheter in adults who need bladder drainage for at least four weeks. Researchers will randomly assign 50 participants to receive either device and will gather feedback through questionnaires and discussion groups. The study also tracks urinary tract infections by analyzing urine samples. The goal is to see if the T-Control design offers a better daily experience for people facing long-term catheterization.

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 device designed for long-term bladder drainage, compared with a standard Foley catheter
What this could lead to
If it works, this could point toward a more comfortable and safer option for people who need long-term bladder catheters, potentially reducing infections and improving daily life.
What could go wrong
This is a small pilot study with 50 participants, so results may not apply broadly. The new catheter might not prove better than the standard one, and any device carries risks like infection 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 50 people

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

Started

Sep 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

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: * Man or women equal or over 18 years old * Patients who require a change of bladder catheter. * Indication of bladder catheterization for 4 weeks. * Maintained cognitive and physical capacity for self-monitoring of the T-Control ® catheter valve. * Agree to participate in the study and sign the informed consent. Exclusion Criteria: * Symptoms of infection at the time of inclusion in the study. * Use of current antibiotic treatment or in the 2 weeks prior to inclusion in the study. * Patients with malformations in the urinary tract * Immunocompromised patients, diagnosed with cancer or AIDS. * Urological cancer patients * Patients who require continuous urine drainage (in the case of patients in the study arm) or hourly urine output measurement. * Catheter insertion requiring more than one attempt. * Inability to read and understand Spanish

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As listed by the trial registrant

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

Catheter related complication Catheter-associated urinary tract infection Quality of life

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario de Canarias

    RECRUITING

    Santa Cruz de Tenerife, Tenerife, 38320, Spain

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