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

ReThink Medical

Status: Suspended

Conditions: Quality of Life; Catheter Related Complication; Catheter; Infection (Indwelling Catheter)

Treatments: Device: Foley-type catheter; Device: T-Control® catheter

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06474845

RM-TCONTROL-2024-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men or women aged ≥18 years
• Patients who require change of bladder catheter.
• Patients with indication of bladder catheterization for at least 4 weeks.
• Patients who maintain cognitive and physical ability for self-monitoring of the catheter valve.
• Patients who sign ICF prior to the performance of any study-specific procedure.

Exclusion criteria

• Use of current antibiotic treatment or in the 2 weeks prior to the study inclusion.
• Patients undergoing chemotherapy, radiotherapy, immunosuppressants or retroviral treatment.
• Patients with bilateral obstructive supravesical uropathy.
• Inability to read and understand the language of the Hospital's country.
• Patients who are participating in a clinical trial or intends to participate during the course of this study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Experimental arm (T-Control®)

Experimental group

Description:

Patients catheterized with a catheter with a control valve for intermittent drainage

Treatment:

Device: T-Control® catheter

Control arm (Foley)

Active Comparator group

Description:

Patients catheterized with a conventional urinary catheter with continuous drainage

Treatment:

Device: Foley-type catheter