Clinical trial NCT05860231: Comparative Study Between Foley and T-Control® Catheter in Patients With Long-term Catheterization
Official title: Comparative Mixed Study of the Foley Catheter With the T-Control® Catheter in Patients With Long-term Catheterization
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Catheter-Associated Urinary Tract Infection
Catheter Related Complication
Quality of Life
Keywords: Catheterisation
T-Control
Foley catheter
Bladder catheter
Urinary catheter
Lead sponsor: Rethink Medical SL
Sponsor class: INDUSTRY
First posted: 2023-05-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Man or women equal or over 18 years old
* Patients who require a change of bladder catheter.
* Indication of bladder catheterization for 4 weeks.
* Maintained cognitive and physical capacity for self-monitoring of the T-Control ® catheter valve.
* Agree to participate in the study and sign the informed consent.

Exclusion Criteria:

* Symptoms of infection at the time of inclusion in the study.
* Use of current antibiotic treatment or in the 2 weeks prior to inclusion in the study.
* Patients with malformations in the urinary tract
* Immunocompromised patients, diagnosed with cancer or AIDS.
* Urological cancer patients
* Patients who require continuous urine drainage (in the case of patients in the study arm) or hourly urine output measurement.
* Catheter insertion requiring more than one attempt.
* Inability to read and understand Spanish

Primary outcomes:
measure: Patient experience for both types of catheterization
timeFrame: Through study completion, an average of 9 months
measure: Self-perceived general health status using 5 dimensions of 5 levels each, and a VAS ranging from 0 to 100.
timeFrame: Day 28 after inclusion
measure: Quantitively assessed self-perceived catheter-related experience
timeFrame: Day 28 after inclusion
Secondary outcomes:
measure: Rate and magnitude of infections (symptomatic and asymptomatic)
timeFrame: Day 28 after inclusion
measure: Catheter tip-positive culture rate
timeFrame: Day 28 after inclusion
measure: Number of adverse events related to catheterization
timeFrame: Day 28 after inclusion
measure: Indication of antibiotic treatments
timeFrame: Day 28 after inclusion
measure: Total costs of each type of catheterization (cost-effectiveness) per quality-adjusted life year (QALY) of catheterized participants
timeFrame: Through study completion, an average of 9 months
measure: The workload perceived by health professionals participating in the study.
timeFrame: Through study completion, an average of 9 months
measure: Opinion of healthcare professionals of the devices used during the study
timeFrame: Through study completion, an average of 9 months
Other outcomes:
Locations:
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario de Canarias
state: Tenerife
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
affiliation: Hospital Universitario 12 de Octubre
name: José Medina-Polo, Dr.
role: PRINCIPAL_INVESTIGATOR
References: