Efficacy of the T-Control® Catheter Compared to the Foley-type Catheter in Patients With Long-term Catheterization
NCT Number: NCT06474845
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Catheter; Infection (Indwelling Catheter)|Quality of Life|Catheter Related Complication
Interventions: DEVICE: T-Control® catheter|DEVICE: Foley-type catheter
Sponsor: Rethink Medical SL
Collaborators: Evidenze Health España (CRO)|Centro para el Desarrollo Tecnológico y la Innovación (CDTI), Spain
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2025-06

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). 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.

Primary Outcome Measures: 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., 4 weeks|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, 4 weeks
Secondary Outcome Measures: 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)., 4 weeks|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., 4 weeks|Adverse events, Number of adverse events realated to catheterization, 4 weeks|Antibiotic treatments, Number of antibiotic treatments administered along with the dose and treatment time, 4 weeks|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), 4 weeks|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, 9 months