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

NCT ID: NCT05860231

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2026-06-01

Brief 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.

Detailed Description

This is a mixed study, in which, on the one hand, a pilot, randomized, two-arm comparative study will be carried out to compare the T-Control® catheter versus the Foley-type catheter in patients with long-term catheterization, monitoring the patient from the insertion of the catheter until its removal or change (4 weeks). On the other hand, a study will be carried out with qualitative methodology, through discussion groups to explore the experience of the patients who participated in the part of the study with quantitative methodology.

The sample of patients will be recruited in the urology service of Hospital 12 de Octubre. The identification of patients eligible to participate will be carried out by members of the urology service staff. During the inclusion period, all those patients who require a long-term bladder catheter change will be invited to participate, who will be interviewed at an initial visit, where the inclusion and exclusion criteria will be checked, the patients will receive information about the study, they will decide whether or not they want to participate, they will sign and deliver the written informed consent and they will be randomly included in the study in one of the two arms, study group (patients catheterized with T-Control®) and control group (patients catheterized with conventional Foley). Both inclusion and randomization will be performed by the investigator responsible for catheter insertion. During this initial visit, patients who decide to participate and meet the criteria will receive an incident diary to keep and record follow-up, and the catheter will be inserted.

Four weeks after bladder catheter insertion, patients will be called for a follow-up visit, during which the study catheter will be removed or replaced.

If the patient is selected for the discussion group, during this follow-up visit they will be informed of the date and place where the qualitative study will be carried out. The discussion groups will be moderated by a researcher with experience in this field who does not have a therapeutic relationship with the participants.

Conditions

Catheter-Associated Urinary Tract Infection; Catheter Related Complication; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control arm (Foley catheter)

When randomly allocated to this arm, a conventional Foley-type catheter will be inserted during all the study period (4 weeks). At day 28 after inclusion, the patient will be called for a follow-up visit to remove the catheter.

Group Type: ACTIVE_COMPARATOR

Foley catheter

Intervention Type: DEVICE

Silicone Foley catheters are transurethral balloon catheters used for the treatment of bladder emptying disorders, as well as for drainage of urine from the urinary tract, continuous fluid irrigation, and/or medication administration. Its use is suitable for a prolonged period of no more than 29 days and is used in Urology, Internal Medicine, Surgery, Obstetrics and Gynaecology Services.

For this study, conventional Foley-type catheters whose use is approved in Spain for routine use will be used. Silicone Foley catheters, usually available in 2- and 3-way, are made of silicone and consist of a body, drainage funnel, inflation funnel, irrigation funnel (if present, only on 3-way catheters) and balloon valve. The product is sterile and single use.

T-Control arm

When randomly allocated to this arm, the T-Control catheter will be inserted during all the study period (4 weeks). At day 28 after inclusion, the patient will be called for a follow-up visit to remove the catheter.

Group Type: EXPERIMENTAL

T-Control catheter

Intervention Type: DEVICE

The T-control® catheter is a flexible, sterile silicone tube with an inflatable balloon at the distal tip, a polytetrafluroethylene membrane integrated into its body, and a sliding fluid control valve. The valve, built into the catheter, provides additional functions to the catheter, such as turning urine flow on and off after insertion (functions currently provided by accessories such as caps or valves) and controlling urination during the insertion process (function that is not provided by any other device). In this way, accidental loss of urine can be avoided from the first moment of use until its withdrawal. Additionally, it has a safety cap that reduces the possibility of accidental movements of the valve before use or during transport and fixing. The design has been developed in such a way that, once inserted, it facilitates autonomous use even for the elderly or patients with limited manual dexterity. The device is sterile and single use, like any conventional Foley catheter.

Interventions

Foley catheter

Silicone Foley catheters are transurethral balloon catheters used for the treatment of bladder emptying disorders, as well as for drainage of urine from the urinary tract, continuous fluid irrigation, and/or medication administration. Its use is suitable for a prolonged period of no more than 29 days and is used in Urology, Internal Medicine, Surgery, Obstetrics and Gynaecology Services.

For this study, conventional Foley-type catheters whose use is approved in Spain for routine use will be used. Silicone Foley catheters, usually available in 2- and 3-way, are made of silicone and consist of a body, drainage funnel, inflation funnel, irrigation funnel (if present, only on 3-way catheters) and balloon valve. The product is sterile and single use.

Intervention Type: DEVICE

T-Control catheter

The T-control® catheter is a flexible, sterile silicone tube with an inflatable balloon at the distal tip, a polytetrafluroethylene membrane integrated into its body, and a sliding fluid control valve. The valve, built into the catheter, provides additional functions to the catheter, such as turning urine flow on and off after insertion (functions currently provided by accessories such as caps or valves) and controlling urination during the insertion process (function that is not provided by any other device). In this way, accidental loss of urine can be avoided from the first moment of use until its withdrawal. Additionally, it has a safety cap that reduces the possibility of accidental movements of the valve before use or during transport and fixing. The design has been developed in such a way that, once inserted, it facilitates autonomous use even for the elderly or patients with limited manual dexterity. The device is sterile and single use, like any conventional Foley catheter.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rethink Medical SL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

José Medina-Polo, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario 12 de Octubre

Locations

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Tenerife, Spain

Countries

Spain

Other Identifiers

RM-TCONTROL-2022-02

Identifier Type: -

Identifier Source: org_study_id