Clinical trial NCT05643950: Effectiveness and Cost-effectiveness of the T-Control® Catheter in Patients With Acute Urine Retention
Official title: Evaluation of the Efficacy and Cost-effectiveness of the T-Control® Catheter Versus the Foley Type Catheter in Patients With Acute Urinary Retention. Randomized Controlled Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Urinary Retention
Catheter-Associated Urinary Tract Infection
Catheter Complications
Keywords: Catheterisation
T-Control
Urinary catheter
Foley catheter
Lead sponsor: Rethink Medical SL
Sponsor class: INDUSTRY
First posted: 2022-12-09
Enrollment: 0
Sex: MALE
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The general purpose of this study is to assess the preliminary effectiveness and cost-effectiveness of the T-Control® catheter versus the Foley type catheter in patients with Acute Urine Retention.

Detailed description: Potential participants will be identified by the team of healthcare professionals of the emergency department according to the inclusion and exclusion criteria of the study. If the patient meets the criteria, the emergency department team will be able to refer patients directly to the urology department, where the investigator or research assistant will again check the inclusion and exclusion criteria, will invite the patient or their relative/caregiver (if necessary) to participate in the study and will request their informed consent. The catheter insertion will be carried out by the research staff after the inclusion and randomisation of the participants.

After catheter insertion, participants and their family, friends, or other informal caregivers will receive information about wearing an indwelling urinary catheter and specific information to randomly inserted, standard Foley, or T-Control® catheters. Standard catheter care is permitted during the trial both managed by the participants and participants' caregivers. Additionally, participants will receive an incident diary in which participants can record any type of incident during the bladder catheterisation period. Two weeks after indwelling bladder catheter insertion, participants will be contacted by urology outpatients for a follow-up visit, during which the study catheter will be removed.

Finally, within a maximum period of two weeks after the follow-up visit, the participants will be invited to participate in an interview to assess the quality of life perceived by the participants during the study

Eligibility criteria: Inclusion Criteria:

* Males with Acute Urine Retention
* Equal or over 50 years of age
* Absence of symptoms of infection on the inclusion day
* Not having been previously catheterized on the day of inclusion
* Indication of bladder catheterization for 2 weeks
* Maintained cognitive and physical capacity for self-monitoring the catheter valve
* Signed consent agreement

Exclusion Criteria:

* Current or recent urinary tract infection in the last 2 weeks
* Use of current treatment/antibiotic in the last 2 weeks
* Immunocompromised patients (diagnosed with advance cancer, Acquired Immunodeficiency Syndrome,...)
* Catheter insertion requiring more than 1 attempt
* Overactive bladder
* Patients with bilateral obstructive uropathy

Primary outcomes:
measure: Magnitude of infections
timeFrame: Day 14 after inclusion (follow-up visit)
Secondary outcomes:
measure: Rate of symptomatic and asymptomatic infections
timeFrame: Day 14 after inclusion (follow-up visit)
measure: Self-perceived health-related quality of life (HRQoL)
timeFrame: Day 14 after inclusion (follow-up visit)
measure: Indication of antibiotic treatments
timeFrame: Day 14 after inclusion (follow-up visit)
measure: Determination of the biofilm formed in the catheters
timeFrame: Day 14 after inclusion (follow-up visit)
measure: Number of adverse events related to catheterization
timeFrame: Day 14 after inclusion (follow-up visit)
measure: Total costs of each type of catheterization (cost-effectiveness) per quality-adjusted life year (QALY) of catheterized participants
timeFrame: Close-out of the study
measure: Level of satisfaction and workload of health professionals.
timeFrame: Close-out of the study
measure: Acceptability of the T-Control® device
timeFrame: Day 14 after inclusion (follow-up visit)
Other outcomes:
Locations:
city: Las Palmas De Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria
state: Las Palmas
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de Candelaria
Study officials:
affiliation: Hospital Universitario Insular de Gran Canaria
name: Laura Vera, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of the Nuestra Señora de Candelaria
name: Adrián Amador, Dr.
role: PRINCIPAL_INVESTIGATOR
References: