SuspendedNot Applicable

Efficacy of the T-Control® Catheter Compared to the Foley-type Catheter in Patients With Long-term Catheterization

Stopped: Study was stopped due to issues with investigational device impacting its functionality and user handling. The sponsor decided to implement necessary design and/or material modifications to improve performance and safety before resuming recruitment.

Portugal, Spain300 participantsStarted 2024-02-10

Plain-language summary

The goal of this clinical trial is to learn if the new urinary catheter T-Control® allows a reduction in infections associated with urinary catheters and a better quality of life of urinary catheter patients compared to the conventional Foley-type catheter (the currently used in clinical practice). It will also learn about the safety profile of the T-Control® catheter and its cost-effectiveness. The main questions it aims to answer are: Does the T-Control® catheter lower the number of infections of the patients who need long-term catheterization? Does he T-Control® catheter implies a better perceived quality of life of long-term catheterization patients? Participants will: Be catheterized with T-Control® or Foley catheter. Visit the clinic after 4 weeks for checkups, fullfill questionnaires and tests. Keep a diary of their symptoms and adverse events related to the catheter.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of Catheter-Associated Urinary Tract Infections (symptomatic and asymptomatic)

Timeframe: 4 weeks

Magnitude of Catheter-Associated Urinary Tract Infections (symptomatic and asymptomatic)

Timeframe: 4 weeks

Trial details

NCT IDNCT06474845

SponsorRethink Medical SL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-01

View on ClinicalTrials.gov More Catheter; Infection (Indwelling Catheter) trials