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Catheter; Infection (Indwelling Catheter)NCT06474845

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

A study testing Foley-type catheter in people with Catheter; Infection (Indwelling Catheter) and Quality of Life, run by Rethink Medical SL at 6 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Foley-type catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
6 sitesin 2 countries
Study dates
10 Feb 2024to 1 Sep 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Portugal3 sites

  • Prof. Doutor Fernando Fonseca Hospital

    Amadora, 2720-276

  • Egas Moniz Hospital

    Lisbon, 1349-019

  • Unidade Local de Saúde de Santa Maria - Centro de Investigação Clínica

    Lisbon, 1649-028

Other trials in Portugal

Spain3 sites

  • Regional University Hospital of Malaga

    Málaga, Andalucía/Spain, 29010

  • Rey Juan Carlos University Hospital

    Móstoles, Madrid/Spain, 28933

  • La Fe University and Polytechnic Hospital

    Valencia, Valencia, 46026

Other trials in Spain

About this study

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

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?

Read more

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.

Read the 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.

Being tested
T-Control® catheter, Foley-type catheter
Keywords
Catheterization, CAUTI, Foley catheter, QoL
Medical subject headings
Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • T-Control® catheterDevice

    Patients will be catheterized with T-Control® for 4 weeks

  • Foley-type catheterDevice

    Patients will be catheterized with a conventional Foley-type catheter for 4 weeks

Study groups in NCT06474845
Study groupRoleWhat they receive
Experimental arm (T-Control®)ExperimentalPatients catheterized with a catheter with a control valve for intermittent drainage
Receives: Device: T-Control® catheter
Control arm (Foley)Active comparatorPatients catheterized with a conventional urinary catheter with continuous drainage
Receives: Device: Foley-type catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Catheter-Associated Urinary Tract Infections (symptomatic and asymptomatic)

    Number of infections divided by number of patients. 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.

    Measured: 4 weeks

  2. Magnitude of Catheter-Associated Urinary Tract Infections (symptomatic and asymptomatic)

    Amount of pathogenic microorganisms present in urine (in CFU/ml) divided by number of patients

    Measured: 4 weeks

Secondary outcomes (6)

  1. Health Related Quality of Life (HRQoL)

    The EuroQ-5Dimensions-5Levels questionnaire will be administered to assess the HRQoL. The questionnaire comprises five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) with 5 levels each (no problems, mild problems, moderate problems, severe problems and extreme problems/disability). The response results in a 1-digit number that expresses the selected level for that dimension. The digits of the five dimensions can be combined into a 5-digit number that describes the health status of the patient. The minimum value is 11111, indicating the worse outcome, whereas the maximum value is 55555, indicating the better outcome. In addition, it also features the EuroQoL Visual Analog Scale (EQ VAS), which records the patient's self-rated health on a vertical visual analog scale from 0 to 100, where the endpoints are labelled "The best health you can imagine" (100) and "The worst health you can imagine" (0).

    Measured: 4 weeks

  2. Catheter Related Quality of Life

    A specific questionnaire to measure the self-perceived quality of life of catheterized patients will be administered. It includes questions that collect data on the type of the bladder catheter and on the accessories used (collection bag, plug or others), questions related to the impact of the catheter in lifestyle and change of habits, functionality and usability in relation to the catheter and the accessories used, adverse events, and emotions perceived due to the use of the bladder catheter.

    In order to quantitatively evaluate the responses, the statements will include response options with scores on a scale of 1 to 5 or 1 to 10. The maximum score is 200, indicating the worst perceived quality of life, whereas 26 is the minimum score, indicating the better perceived quality of life.

    Measured: 4 weeks

  3. Adverse events

    Number of adverse events realated to catheterization

    Measured: 4 weeks

  4. Antibiotic treatments

    Number of antibiotic treatments administered along with the dose and treatment time

    Measured: 4 weeks

  5. Cost-effectiveness

    Incremental cost-effectiveness ratio (ICER) will be used, which results from dividing the difference in costs between alternatives by the difference in effectiveness (incremental cost per QALY gained)

    Measured: 4 weeks

  6. Satisfaction of health professionals

    The degree of satisfaction of the members of the research team involved in the use of the catheters will be evaluated through an ad hoc questionnaire

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2024
  2. Study start10 Feb 2024
  3. Primary completion1 May 2026
  4. Study completion1 Sep 2026

Why it stopped: Study was terminated due to lack of funding.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Comparative, randomized, controlled, multicentric clinical study with two arms
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06474845
Sponsor's protocol ID
RM-TCONTROL-2024-05
Status last verified
Sep 2026
First submitted
18 Jun 2024
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in a publication will be available from the Sponsor upon reasonable request.

Questions about this trial

What is this clinical trial studying?

A study testing Foley-type catheter in people with Catheter; Infection (Indwelling Catheter) and Quality of Life, run by Rethink Medical SL at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Portugal, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Study was terminated due to lack of funding.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Catheter-Associated Urinary Tract Infections (symptomatic and asymptomatic) (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06474845.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

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