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

Comparative Mixed Study of the Foley Catheter With the T-Control® Catheter in Patients With Long-term Catheterization

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Catheter Related Complication; Catheter-Associated Urinary Tract Infection
• Intervention / Treatment: Device: Foley catheter; Device: T-Control 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manuel Luque; Phone Number: +34 646307642; Email: mluque@rethinkmedical.es
• Study Contact Backup: Name: Santiago Pérez García, PhD; Phone Number: 4689 +34 917792689; Email: idi.hdoc@salud.madrid.org

Study Locations

• Spain
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre
    • Contact: Santiago Pérez García, PhD; Phone Number: 4689 +34 917792689; Email: idi.hdoc@salud.madrid.org
    • Principal Investigator: José Medina Polo, Dr
  • Tenerife
    • Santa Cruz De Tenerife, Tenerife, Spain, 38320
      • Recruiting
      • Hospital Universitario de Canarias
      • Contact: Manuel Luque, RN; Phone Number: +34646 30 76 42; Email: mluque@rethinkmedical.es
      • Principal Investigator: Bárbara Yolanda Padilla Fernández, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate and magnitude of infections (symptomatic and asymptomatic)	The number of urinary tract infections will be obtained from the analysis of urine samples taken from patients. The research staff will take two samples from each patient, one at the time of inclusion in the study and another at the follow-up visit, four weeks after the insertion of the probe, coinciding with the change of the catheter. The presence of pathogenic microorganisms in quantities greater than or equal to 1,000 CFU/ml will determine the presence of infection, while, in the absence of symptoms of infection, a determination of microorganisms greater than or equal to 100,000 CFU/ml will indicate asymptomatic infection.	Day 28 after inclusion
Catheter tip-positive culture rate	A 1 cm catheter between the fixation balloon of the bladder catheter will be sectioned in a sterile manner, sent in a sterile container to the microbiology laboratory to analyze and identify the type of microorganisms.	Day 28 after inclusion
Number of adverse events related to catheterization	The type and number of adverse events will be recorded: accidental disconnection of the catheter, obstruction, pain, loss of urine per catheter, haematuria and accidental spills caused by the professional during the moment of insertion.	Day 28 after inclusion
Indication of antibiotic treatments	The antibiotic that has been administered associated with the use of the catheter will be recorded.	Day 28 after inclusion
Total costs of each type of catheterization (cost-effectiveness) per quality-adjusted life year (QALY) of catheterized participants	The costs derived from the catheterization, such as the consumption of consumable materials and resources, diagnostic tests (urine cultures and catheter cultures and biofilm analysis) will be collected. The budgetary impact derived from the incorporation of T-Control® into the service portfolio of Spanish hospitals will be included. The main outcome measure will be the incremental cost per quality-adjusted life year (QALY) gained, a generic health measure that combines information on life expectancy with the patient's quality of life, the latter measured through the EuroQoL-5 Dimensions-5 Levels instrument. The perspective of the analysis will be that of the hospital, in which only direct healthcare costs will be included.	Through study completion, an average of 9 months
The workload perceived by health professionals participating in the study.	The following instrument is administered to health professionals: National Aeronautics and Space Administration - Task Load Index. This questionnaire is a subjective, multidimensional evaluation tool that qualifies the perceived workload to evaluate the effectiveness of a task, system or equipment or other aspects of performance. The questionnaire evaluates 6 dimensions (mental, physical and temporal demand, performance, effort and frustration) allowing to rate them in a 1 (lowest) to 10 (highest) scale.	Through study completion, an average of 9 months
Opinion of healthcare professionals of the devices used during the study	The following instrument is administered to health professionals: Health professional satisfaction questionnaire. A questionnaire specifically developed by Rethink Medical to quantitatively measure preferences, problems and advantages encountered with the devices used. This questionnaire includes a first section with 12 statements regarding the catheter insertion process, the health professionals will rate these statements for both devices used during the clinical trial in a 1 to 5 scale depending if they agree (5) or not (1) with the statements. The second section is intended for health professionals to make a comparison between both devices through 11 statements for which they will have to indicate which device best fits these statements according to their opinion, being able to choose only one device for each statement. Finally, the questionnaire consists of a free section in which health professionals can write any comments or suggestions).	Through study completion, an average of 9 months

Collaborators and Investigators

• Sponsor: Rethink Medical SL
• Investigators: Principal Investigator: José Medina-Polo, Dr., Hospital Universitario 12 de Octubre

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Urinary catheter; Catheterisation; T-Control; Foley catheter; Bladder catheter
• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Tract Infections
• Other Study ID Numbers: RM-TCONTROL-2022-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The requests for participant-level data and/or statistical code can be made in writing to info@rethinkmedical.es. The final trial dataset generated and/or analysed during the study may be available on reasonable request to the research coordinator and Sponsor.
• IPD Sharing Time Frame: Starting 2 months after publication.
• IPD Sharing Access Criteria: Review requests and criteria for reviewing requests will be carried out by the Principal Investigators and Sponsor.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No