efficacy of the t-control® catheter compared to the foley-type catheter in patients with long-term catheterization

Conditions: Catheter; Infection (Indwelling Catheter); Quality of Life; Catheter Related Complication

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.

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.

Eligibility criteria:
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.

Keywords: catheterization cauti foley catheter qol