Comparing T-Control and Foley Catheters for Long-Term Bladder Catheter Patients
Official title: Comparative Mixed Study of the Foley Catheter With the T-Control® Catheter in Patients With Long-term Catheterization
Run by Rethink Medical SL · NCT05860231 · Data updated 2026-11-12
This pilot randomized study tests whether the T-Control catheter provides more comfort and a better experience than a standard Foley catheter for people needing a long-term bladder tube.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Rethink Medical SL Industry-sponsored |
| Locations | 2 sites (Santa Cruz de Tenerife, Tenerife and 1 other locations) |
| Status | Recruiting |
| Started | September 1, 2023 |
| Main results expected | March 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | September 4, 2026 |
| Trial ID | NCT05860231 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 or older who require a long-term bladder catheter change and can self-monitor the valve.
✕Probably not a fit
Patients with active infection, recent antibiotic use, or conditions preventing catheter use or self-monitoring may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a two-arm pilot trial comparing T-Control® versus Foley catheters in adults requiring long-term bladder catheterization. Participants will be followed from catheter insertion to removal or change over about four weeks, with quantitative outcomes on efficacy and comfort and qualitative discussions to capture patient experiences. The study is conducted at two Spanish hospitals and includes randomization and standard ethical procedures. A qualitative component will explore patient perspectives to complement the quantitative data. Inclusion criteria require adults needing catheter change and able to self-monitor the valve, while exclusions cover active infection, recent antibiotics, and certain medical conditions.
Why it matters
Potential benefit: If successful, patients may experience greater comfort and a better overall experience with catheter care using the T-Control catheter.
How similar studies have gone: Previous similar approaches have shown promise in improving comfort with alternative catheter designs, but this exact comparison is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Tenerife, Spain Recruiting -
Hospital Universitario 12 de Octubre
Madrid, Spain Recruiting
Study contacts
- Principal investigator: José Medina-Polo, Dr. — Hospital Universitario 12 de Octubre
- Study coordinator: Max Mòdol Vidal, Msc
- Email: mmodol@rethinkmedical.es
- Phone: +34 654489436
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.