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

Launched by RETHINK MEDICAL SL · May 5, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two different types of catheters—T-Control® and the regular Foley catheter—to see which one is better for people who need long-term bladder catheterization. The study aims to compare how effective they are, how comfortable they feel, and how they impact the overall experience of patients. If you or someone you know has been using a bladder catheter for at least four weeks and needs a change, this trial may be a good fit.

To participate, individuals need to be at least 18 years old and capable of understanding how to manage the T-Control® catheter valve. However, people with certain conditions, like active infections or specific types of cancer, are not eligible. Participants will be asked to sign an agreement to take part in the study and will help researchers understand which catheter provides a better quality of life. This trial is currently recruiting and welcomes both men and women to join.

Gender

ALL

Eligibility 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