UroShield for preventing catheter-associated urinary tract infections

Technology

2.1 UroShield is an ultrasound device designed to reduce the risk of catheter-associated urinary tract infection (UTI) by reducing bacterial colonisation and biofilm formation on indwelling urinary catheters. The technology works by generating low intensity 90 kHz ultrasonic surface acoustic waves, which propagate throughout the catheter's length on its inner and outer lumens. The company claims these acoustic waves prevent bacteria attaching and forming a biofilm, and also reduce friction between the catheter and the person's internal tissues. It claims this reduces the pain, discomfort, and spasm associated with indwelling urinary catheters.

2.2 UroShield includes 2 components: a driver, which provides the power, and a single use actuator, which is clipped to the catheter and generates the ultrasonic waves. UroShield can be used with urethral and suprapubic catheters of any material and size ranging from 12 to 22 French gauge. UroShield is worn continuously. The life expectancy of the driver is 2 years while the actuator, according to the instructions for use, should be replaced every 30 days. If the catheter is replaced within 30 days, the actuator can be removed and reattached to the new catheter. UroShield is a CE marked class IIa medical device. UroShield 3.0 is the current version available in the NHS.

Care pathway

2.3 UroShield is an add-on to standard care to prevent catheter-associated UTI. NICE's healthcare-associated infections guideline says that the risk of blockages, encrustations, and catheter-associated infections in long-term urinary catheters should be minimised through patient-specific regimens. These include reviewing the frequency of planned catheter changes, increasing fluid intake, and documenting catheter blockages. Catheters should be changed only when clinically necessary or according to the manufacturer's recommendations. Urinary catheter tools such as a catheter passport, catheter card, and inpatient care plan are used to allow healthcare professionals to document catheter care and share information between care services.

Innovative aspects

2.4 UroShield generates ultrasound acoustic waves that produce microvibrations. The company claims this prevents microbes adhering to the catheter surface. It also claims it may alter the quorum sensing (cell to cell communication) of the microbes, which helps to delay and disrupt the formation of a biofilm and its extracellular matrix. These mechanisms generate the bactericidal effects of the device. The clinical experts all considered UroShield to be novel and innovative.

Intended use

2.5 UroShield is intended to reduce the risk of catheter-associated UTIs in adults with urethral or suprapubic indwelling urinary catheters. It is not intended for use in children. This guidance considers the use of UroShield in hospital and community care. UroShield is not MRI compatible and should be removed from the catheter before entering an MRI suite. It is not intended as a treatment for an active UTI.

Costs

2.6 The costs of UroShield are £349 for the driver and £50 per actuator (excluding VAT).

For more details, see the website for UroShield.