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

NCT05860231 | Suspended

• 1 other identifier: RM-TCONTROL-2022-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Catheterisation; T-Control; Foley catheter; Bladder catheter; Urinary catheter

Outcome Measures

Primary Outcomes (3)

• Patient experience for both types of catheterization

  For data collection, the technique of discussion groups will be used using a semi-structured script, which will serve for the identification of preferences and needs in daily life and for training and information for the use of the devices of catheterised patients. The discussion groups will be audio-recorded, transcribed and moderated by a researcher with experience in this field who does not have a therapeutic relationship with the participants.

  Through study completion, an average of 9 months

• Self-perceived general health status using 5 dimensions of 5 levels each, and a VAS ranging from 0 to 100.

  The following instrument is administered to participants: EuroQol-5 Dimensions-5 Levels. A questionnaire that measures the patient's health status from a physical, psychological and social point of view. It consists of the descriptive system EQ-5D, which comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels ranging from no problems to extreme problems. This decision results in a 1-digit number for each dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. In addition, it also features the EQ Visual Analogue Scale (EQ VAS), which records the patient's self-rated health on a visual analogue scale, where the endpoints are labelled "The best health you can imagine" (100) and "The worst health you can imagine" (0). The VAS can be used as a quantitative measure of health outcomes that reflect the patient's own judgement.

  Day 28 after inclusion

• Quantitively assessed self-perceived catheter-related experience

  Rethink Medical developed a specific instrument created in the context of this project based on the experience of our previous studies. The questionnaire aims to assess the self-perceived quality of life of catheterised patients and includes 29 questions that collect data on the prescription of the bladder catheter and on the accessories used (collection bag, cap or others), questions related to acceptability, usability and satisfaction in relation to the catheter and the accessories used, adverse events and changes in habits associated with the catheterisation and emotions perceived at the beginning and during the use of the bladder catheter. In order to quantitatively assess the answers, the statements will include multiple answer options, single options and answers with scores on a scale of 1 to 10.

  Day 28 after inclusion

Secondary Outcomes (7)

• Rate and magnitude of infections (symptomatic and asymptomatic)

  Day 28 after inclusion

• Catheter tip-positive culture rate

  Day 28 after inclusion

• Number of adverse events related to catheterization

  Day 28 after inclusion

• Indication of antibiotic treatments

  Day 28 after inclusion

• Total costs of each type of catheterization (cost-effectiveness) per quality-adjusted life year (QALY) of catheterized participants

  Through study completion, an average of 9 months

Study Arms (2)

Control arm (Foley catheter)

ACTIVE COMPARATOR

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.

Device: Foley catheter

T-Control arm

EXPERIMENTAL

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.

Device: T-Control catheter

Interventions

Foley catheter 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.

Control arm (Foley catheter)

T-Control catheter 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.

T-Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rethink Medical SL: lead

Study Sites (2)

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Tenerife, 38320, Spain

Location

Study Officials

• José Medina-Polo, Dr.

  Hospital Universitario 12 de Octubre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Data analysis will be blinded to the intervention arm as well as the laboratories that will carry out the analysis of the urine and catheter samples.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 16, 2023
• Study Start: September 1, 2023
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 2 months after publication.
• Access Criteria: Review requests and criteria for reviewing requests will be carried out by the Principal Investigators and Sponsor.

Locations

ES (2)