Effectiveness and Cost-effectiveness of the T-Control® Catheter in Patients With Acute Urine Retention

ReThink Medical

Status: Withdrawn

Conditions: Urinary Retention; Catheter-Associated Urinary Tract Infection; Catheter Complications

Treatments: Device: Foley catheter; Device: T-Control catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT05643950

2022-002862-34 (EudraCT Number)

RM-TCONTROL-2022-01

Details and patient eligibility

About

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.

Full 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

Sex: Male

Ages: 50 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Control arm (Foley catheter)

Active Comparator group

Description:

When randomly allocated to this arm, a conventional Foley-type catheter will be inserted during all the study period (2 weeks). At day 14 after inclusion, the patient will be called for a follow-up visit to remove the catheter.

Treatment:

Device: Foley catheter

T-Control arm

Experimental group

Description:

When randomly allocated to this arm, the T-Control catheter will be inserted during all the study period (2 weeks). At day 14 after inclusion, the patient will be called for a follow-up visit to remove the catheter.

Treatment:

Device: T-Control catheter