Comparative Study Between Foley and T-Control® Catheter in Patients With Long-term Catheterization

Quality of Life Clinical Trial

Official title: Comparative Mixed Study of the Foley Catheter With the T-Control® Catheter in Patients With Long-term Catheterization

Status Recruiting

Clinical Trial Summary

This is a comparative, randomized, controlled pilot study. The main objective of this study is to evaluate the efficacy, comfort, and patient experience in people with long-term bladder catheterization with T-Control® versus patients with a conventional Foley-type catheter.

Clinical Trial Description

This is a mixed study, in which, on the one hand, a pilot, randomized, two-arm comparative study will be carried out to compare the T-Control® catheter versus the Foley-type catheter in patients with long-term catheterization, monitoring the patient from the insertion of the catheter until its removal or change (4 weeks). On the other hand, a study will be carried out with qualitative methodology, through discussion groups to explore the experience of the patients who participated in the part of the study with quantitative methodology.

The sample of patients will be recruited in the urology service of Hospital 12 de Octubre. The identification of patients eligible to participate will be carried out by members of the urology service staff. During the inclusion period, all those patients who require a long-term bladder catheter change will be invited to participate, who will be interviewed at an initial visit, where the inclusion and exclusion criteria will be checked, the patients will receive information about the study, they will decide whether or not they want to participate, they will sign and deliver the written informed consent and they will be randomly included in the study in one of the two arms, study group (patients catheterized with T-Control®) and control group (patients catheterized with conventional Foley). Both inclusion and randomization will be performed by the investigator responsible for catheter insertion. During this initial visit, patients who decide to participate and meet the criteria will receive an incident diary to keep and record follow-up, and the catheter will be inserted.

Four weeks after bladder catheter insertion, patients will be called for a follow-up visit, during which the study catheter will be removed or replaced.

If the patient is selected for the discussion group, during this follow-up visit they will be informed of the date and place where the qualitative study will be carried out. The discussion groups will be moderated by a researcher with experience in this field who does not have a therapeutic relationship with the participants. ;

Related Conditions & MeSH terms

• Catheter Related Complication
• Catheter-Associated Urinary Tract Infection
• Quality of Life
• Urinary Tract Infections

• NCT number: NCT05860231
• Study type: Interventional
• Source: Rethink Medical SL
• Contact: Manuel Luque
• Phone: +34 646307642
• Email: mluque@rethinkmedical.es
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Completion date: December 1, 2024