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Comparative Study Between Foley and T-Control® Catheter in Patients With Long-term Catheterization

RecruitingNAAges 18 Years - anyAllRethink Medical SL
NCT05860231 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a comparative, randomized, controlled pilot study. The main objective of this study is to evaluate the efficacy, comfort, and patient experience in people with long-term bladder catheterization with T-Control® versus patients with a conventional Foley-type catheter.

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📋 Eligibility rules (as published)
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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What it tests

  • Foley catheter
  • T-Control catheter
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Where

2 sites
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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