NCT06474845

Efficacy of the T-Control® Catheter Compared to the Foley-type Catheter in Patients With Long-term Catheterization

Multicentre International Randomized Clinical Study to Assess the Efficacy of the T-Control® Catheter vs. a Conventional Foley-type Catheter

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Rethink Medical SL · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if the new urinary catheter T-Control® allows a reduction in infections associated with urinary catheters and a better quality of life of urinary catheter patients compared to the conventional Foley-type catheter (the currently used in clinical practice). It will also learn about the safety profile of the T-Control® catheter and its cost-effectiveness. The main questions it aims to answer are: Does the T-Control® catheter lower the number of infections of the patients who need long-term catheterization? Does he T-Control® catheter implies a better perceived quality of life of long-term catheterization patients? Participants will: Be catheterized with T-Control® or Foley catheter. Visit the clinic after 4 weeks for checkups, fullfill questionnaires and tests. Keep a diary of their symptoms and adverse events related to the catheter.

Detailed description

This is a comparative, randomized, controlled, multicentric clinical study with two arms in which the T-control® catheter is compared with a conventional Foley-type catheter. The main objective of this study is to determine the efficacy of T-Control® compared to the conventional Foley-type catheter, by comparing the number of CAUTIs (both symptomatic and asymptomatic) in patients with long-term catheterization. While the secondary objectives are: to determine the Health-related QoL (HRQoL) and analyze the self-perceived QoL of catheterized patients, as well as the acceptability of the T-Control® device, patient's satisfaction and patients' experience framed in the trajectory of the disease; to compare the safety profile between T-Control® and the conventional Foley-type catheter and the antibiotics used; to determine the cost-effectiveness of T-Control® versus the conventional Foley-type catheter, from the perspective of the hospital; and to measure the level of satisfaction of healthcare professionals with the different types of urinary catheters. Follow-up includes both the time of the catheter insertion until its removal or change, lasting 4 weeks. All the parameters collected during the follow-up visit refer to the 4 weeks during which the patient has had the catheter inserted.

Conditions

• Catheter; Infection (Indwelling Catheter)
• Quality of Life
• Catheter Related Complication

Interventions

Type	Name	Description
DEVICE	T-Control® catheter	Patients will be catheterized with T-Control® for 4 weeks
DEVICE	Foley-type catheter	Patients will be catheterized with a conventional Foley-type catheter for 4 weeks

Timeline

• Start date: 2024-02-10
• Primary completion: 2026-05-01
• Completion: 2026-08-01
• First posted: 2024-06-26
• Last updated: 2025-05-16

Locations

6 sites across 2 countries: Portugal, Spain