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

NCT ID: NCT05643950

Last Updated: 2023-12-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-04-30

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

Conditions

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

Keywords

Catheterisation; T-Control; Urinary catheter; Foley catheter

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control arm (Foley catheter)

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.

Group Type: ACTIVE_COMPARATOR

Foley catheter

Intervention Type: DEVICE

Silicone Foley catheters are transurethral balloon catheters used for the treatment of bladder emptying disorders, as well as for drainage of urine from the urinary tract, continuous fluid irrigation, and/or medication administration. Its use is suitable for a prolonged period of no more than 29 days and is used in Urology, Internal Medicine, Surgery, Obstetrics and Gynaecology Services.

For this study, conventional Foley-type catheters whose use is approved in Spain for routine use will be used. Silicone Foley catheters, usually available in 2- and 3-way, are made of silicone and consist of a body, drainage funnel, inflation funnel, irrigation funnel (if present, only on 3-way catheters) and balloon valve. The product is sterile and single use.

T-Control arm

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.

Group Type: EXPERIMENTAL

T-Control catheter

Intervention Type: DEVICE

The T-control® catheter is a flexible, sterile silicone tube with an inflatable balloon at the distal tip, a polytetrafluroethylene membrane integrated into its body, and a sliding fluid control valve. The valve, built into the catheter, provides additional functions to the catheter, such as turning urine flow on and off after insertion (functions currently provided by accessories such as caps or valves) and controlling urination during the insertion process (function that is not provided by any other device). In this way, accidental loss of urine can be avoided from the first moment of use until its withdrawal. Additionally, it has a safety cap that reduces the possibility of accidental movements of the valve before use or during transport and fixing. The design has been developed in such a way that, once inserted, it facilitates autonomous use even for the elderly or patients with limited manual dexterity. The device is sterile and single use, like any conventional Foley catheter.

Interventions

Foley catheter

Silicone Foley catheters are transurethral balloon catheters used for the treatment of bladder emptying disorders, as well as for drainage of urine from the urinary tract, continuous fluid irrigation, and/or medication administration. Its use is suitable for a prolonged period of no more than 29 days and is used in Urology, Internal Medicine, Surgery, Obstetrics and Gynaecology Services.

For this study, conventional Foley-type catheters whose use is approved in Spain for routine use will be used. Silicone Foley catheters, usually available in 2- and 3-way, are made of silicone and consist of a body, drainage funnel, inflation funnel, irrigation funnel (if present, only on 3-way catheters) and balloon valve. The product is sterile and single use.

Intervention Type: DEVICE

T-Control catheter

The T-control® catheter is a flexible, sterile silicone tube with an inflatable balloon at the distal tip, a polytetrafluroethylene membrane integrated into its body, and a sliding fluid control valve. The valve, built into the catheter, provides additional functions to the catheter, such as turning urine flow on and off after insertion (functions currently provided by accessories such as caps or valves) and controlling urination during the insertion process (function that is not provided by any other device). In this way, accidental loss of urine can be avoided from the first moment of use until its withdrawal. Additionally, it has a safety cap that reduces the possibility of accidental movements of the valve before use or during transport and fixing. The design has been developed in such a way that, once inserted, it facilitates autonomous use even for the elderly or patients with limited manual dexterity. The device is sterile and single use, like any conventional Foley catheter.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Rethink Medical SL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Vera, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Insular de Gran Canaria

Adrián Amador, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital of the Nuestra Señora de Candelaria

Locations

Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria

Las Palmas de Gran Canaria, Las Palmas, Spain

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, , Spain

Countries

Spain

Other Identifiers

2022-002862-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RM-TCONTROL-2022-01

Identifier Type: -

Identifier Source: org_study_id