Comparative Study Between Foley and T-Control® Catheter in Patients With Long-term Catheterization (NCT05860231) | Clinical Trial Compass
SuspendedNot Applicable
Comparative Study Between Foley and T-Control® 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.
Spain50 participantsStarted 2023-09-01
Plain-language summary
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.
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:
* 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
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
1
Patient experience for both types of catheterization
Timeframe: Through study completion, an average of 9 months
2
Self-perceived general health status using 5 dimensions of 5 levels each, and a VAS ranging from 0 to 100.