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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Rethink Medical SL
- Locations
- 4
- Primary Endpoint
- Magnitude of infections
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Masking Description
Data analysis will be blinded to the intervention arm as well as the laboratories that will carry out the analysis of the urine and catheter samples.
Eligibility Criteria
- Ages
- 50 Years to 100 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Magnitude of infections
Time Frame: Day 14 after inclusion (follow-up visit)
The magnitude of infection will be obtained from the analysis of urine culture samples taken from participants
Secondary Outcomes
- Self-perceived health-related quality of life (HRQoL)(Day 14 after inclusion (follow-up visit))
- Number of adverse events related to catheterization(Day 14 after inclusion (follow-up visit))
- Total costs of each type of catheterization (cost-effectiveness) per quality-adjusted life year (QALY) of catheterized participants(Close-out of the study)
- Determination of the biofilm formed in the catheters(Day 14 after inclusion (follow-up visit))
- Rate of symptomatic and asymptomatic infections(Day 14 after inclusion (follow-up visit))
- Indication of antibiotic treatments(Day 14 after inclusion (follow-up visit))
- Level of satisfaction and workload of health professionals.(Close-out of the study)
- Acceptability of the T-Control® device(Day 14 after inclusion (follow-up visit))