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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
300
Patients will be catheterized with T-Control® for 4 weeks
Patients will be catheterized with a conventional Foley-type catheter for 4 weeks
Prof. Doutor Fernando Fonseca Hospital
Amadora, Portugal
Egas Moniz Hospital
Lisbon, Portugal
Unidade Local de Saúde de Santa Maria - Centro de Investigação Clínica
Lisbon, Portugal
Regional University Hospital of Malaga
Málaga, Andalucía/Spain, Spain
Rey Juan Carlos University Hospital
Móstoles, Madrid/Spain, Spain
La Fe University and Polytechnic Hospital
Valencia, Valencia, Spain
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.
Time frame: 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
Time frame: 4 weeks
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).
Time frame: 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.
Time frame: 4 weeks
Adverse events
Number of adverse events realated to catheterization
Time frame: 4 weeks
Antibiotic treatments
Number of antibiotic treatments administered along with the dose and treatment time
Time frame: 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)
Time frame: 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
Time frame: 9 months
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