Catheter; Infection (Indwelling Catheter), Catheter Related Complication, Quality of Life
Conditions
Keywords
Catheterization, CAUTI, Foley catheter, QoL
Brief 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.
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.
Interventions
DEVICET-Control® catheter
Patients will be catheterized with T-Control® for 4 weeks
DEVICEFoley-type catheter
Patients will be catheterized with a conventional Foley-type catheter for 4 weeks
Sponsors
Rethink Medical SL
Evidenze CRO
Centro para el Desarrollo Tecnológico y la Innovación (CDTI), Spain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the intervention, it is not possible to blind the patient or the healthcare professional; however, the professional who analyses the data will be unaware of the type of catheter used for each patient.
Intervention model description
Comparative, randomized, controlled, multicentric clinical study with two arms
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Catheter-Associated Urinary Tract Infections (symptomatic and asymptomatic) | 4 weeks | 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. |
| Magnitude of Catheter-Associated Urinary Tract Infections (symptomatic and asymptomatic) | 4 weeks | Amount of pathogenic microorganisms present in urine (in CFU/ml) divided by number of patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Related Quality of Life (HRQoL) | 4 weeks | 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). |
| Catheter Related Quality of Life | 4 weeks | 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. |
| Adverse events | 4 weeks | Number of adverse events realated to catheterization |
| Antibiotic treatments | 4 weeks | Number of antibiotic treatments administered along with the dose and treatment time |
| Cost-effectiveness | 4 weeks | 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) |
| Satisfaction of health professionals | 9 months | 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 |
Countries
Portugal, Spain
Contacts
STUDY_CHAIRJose Medina-Polo, Dr.
Hospital Universitario 12 de Octubre
PRINCIPAL_INVESTIGATORSalvador Arlandis Guzmán, Dr.
La Fe University and Polytechnic Hospital
PRINCIPAL_INVESTIGATORRaúl Vozmediano Chicharro, Dr.
Carlos Haya Regional University Hospital
PRINCIPAL_INVESTIGATORDavid Carracedo Calvo, Dr.
Rey Juan Carlos University Hospital
PRINCIPAL_INVESTIGATORJose Carlos Santos, Dr.
Hospital Egas Moniz
PRINCIPAL_INVESTIGATORAlberto Marques Silva, Dr.
Prof. Doutor Fernando Fonseca Hospital
PRINCIPAL_INVESTIGATORJosé Manuel Palma dos Reis, Dr.
Unidade Local de Saúde de Santa Maria - Centro de Investigação Clínica
Outcome results
None listed