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

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.

Conditions

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

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

• Rethink Medical SL

  lead INDUSTRY

Principal Investigators

• Laura Vera, Dr. · Hospital Universitario Insular de Gran Canaria

• Adrián Amador, Dr. · University Hospital of the Nuestra Señora de Candelaria

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

100 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-01

Primary Completion

2023-12-31

Completion

2024-04-30

Countries

• Spain

Study Locations