WithdrawnNot Applicable

Effectiveness and Cost-effectiveness of the T-Control® Catheter in Patients With Acute Urine Retention

Stopped: Lack of patient recruitment by centers

Spain0Started 2023-08-01

Plain-language summary

The general purpose of this study is to assess the preliminary effectiveness and cost-effectiveness of the T-Control® catheter versus the Foley type catheter in patients with Acute Urine Retention.

Who can participate

Age range

50 Years – 100 Years

Sex

MALE

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: * Males with Acute Urine Retention * Equal or over 50 years of age * Absence of symptoms of infection on the inclusion day * Not having been previously catheterized on the day of inclusion * Indication of bladder catheterization for 2 weeks * Maintained cognitive and physical capacity for self-monitoring the catheter valve * Signed consent agreement Exclusion Criteria: * Current or recent urinary tract infection in the last 2 weeks * Use of current treatment/antibiotic in the last 2 weeks * Immunocompromised patients (diagnosed with advance cancer, Acquired Immunodeficiency Syndrome,...) * Catheter insertion requiring more than 1 attempt * Overactive bladder * Patients with bilateral obstructive uropathy

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

Magnitude of infections

Timeframe: Day 14 after inclusion (follow-up visit)

Trial details

NCT IDNCT05643950

SponsorRethink Medical SL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12

View on ClinicalTrials.gov More Urinary Retention trials