Clinical trial NCT06474845: Efficacy of the T-Control® Catheter Compared to the Foley-type Catheter in Patients With Long-term Catheterization
Official title: Multicentre International Randomized Clinical Study to Assess the Efficacy of the T-Control® Catheter vs. a Conventional Foley-type Catheter
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Catheter; Infection (Indwelling Catheter)
Quality of Life
Catheter Related Complication
Keywords: Catheterization
CAUTI
Foley catheter
QoL
Lead sponsor: Rethink Medical SL
Sponsor class: INDUSTRY
Collaborators: name: Evidenze Health España (CRO)
name: Centro para el Desarrollo Tecnológico y la Innovación (CDTI), Spain
First posted: 2024-06-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparative, randomized, controlled, multicentric clinical study with two arms
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Rate of Catheter-Associated Urinary Tract Infections (symptomatic and asymptomatic)
timeFrame: 4 weeks
measure: Magnitude of Catheter-Associated Urinary Tract Infections (symptomatic and asymptomatic)
timeFrame: 4 weeks
Secondary outcomes:
measure: Health Related Quality of Life (HRQoL)
timeFrame: 4 weeks
measure: Catheter Related Quality of Life
timeFrame: 4 weeks
measure: Adverse events
timeFrame: 4 weeks
measure: Antibiotic treatments
timeFrame: 4 weeks
measure: Cost-effectiveness
timeFrame: 4 weeks
measure: Satisfaction of health professionals
timeFrame: 9 months
Other outcomes:
Locations:
city: Amadora
country: Portugal
facility: Prof. Doutor Fernando Fonseca Hospital
city: Lisboa
country: Portugal
facility: Egas Moniz Hospital
city: Lisboa
country: Portugal
facility: Unidade Local de Saúde de Santa Maria - Centro de Investigação Clínica
city: Málaga
country: Spain
facility: Regional University Hospital of Malaga
state: Andalucía/Spain
city: Valencia
country: Spain
facility: La Fe University and Polytechnic Hospital
state: Comunitat Valenciana
city: Móstoles
country: Spain
facility: Rey Juan Carlos University Hospital
state: Madrid/Spain
Study officials:
affiliation: Hospital Universitario 12 de Octubre
name: Jose Medina-Polo, Dr.
role: STUDY_CHAIR
affiliation: La Fe University and Polytechnic Hospital
name: Salvador Arlandis Guzmán, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Carlos Haya Regional University Hospital
name: Raúl Vozmediano Chicharro, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rey Juan Carlos University Hospital
name: David Carracedo Calvo, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Egas Moniz
name: Jose Carlos Santos, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Prof. Doutor Fernando Fonseca Hospital
name: Alberto Marques Silva, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Unidade Local de Saúde de Santa Maria - Centro de Investigação Clínica
name: José Manuel Palma dos Reis, Dr.
role: PRINCIPAL_INVESTIGATOR
References: