Device is only system that integrates a guidewire into a standard Foley catheter
The Urethrotech urethral catheterisation device is the subject of a new Medtech Innovation Briefing
A new-style catheterisation system is the subject of the latest Medtech Innovation Briefing from the National Institute for Health and Care Excellence (NICE).
The briefings aim to support NHS and social care commissioners and staff who are considering using new medical devices and other medical or diagnostic technologies.
The information provided includes a description of the technology, how it’s used, and its potential role in the treatment pathway.
They also include a review of relevant published evidence and the likely costs of using the technology, but they are not NICE guidance and do not make any recommendations on the value of using the technologies. Whether or not to use the products described is entirely the choice of local staff.
However, they will help to avoid the need for organisations to produce similar information, so saving staff time, effort and resources.
The latest briefing explores the potential uses for the Urethrotech urethral catheterisation device (UCD).
The device comprises a flexible hydrophilic Nitinol guidewire, which protrudes 50cm from the tip of a standard 5.3mm diameter three-way Foley catheter.
The user lubricates the soft tip of the guidewire with sterile water before inserting it through the urethra and into the bladder.
The guidewire is designed to allow the catheter to be navigated around an enlarged prostate and the soft tip is designed to avoid urethral trauma and will turn back if the wire is pushed against an obstruction or a non-negotiable false passage.
When the guidewire enters the bladder, it curls up on itself as the catheter is advanced. The catheter is then passed over the guidewire when it reaches the tip of the penis. When the catheter reaches the bladder, urine should flow freely through the main catheter urine drainage channel. This indicates that the catheter is correctly positioned and that the balloon at the end may be safely inflated so that the catheter stays in place. The guidewire is then withdrawn and disposed of.
The catheter can remain in place for up to 30 days, after which it must be replaced.
Designed to be used for difficult or failed catheterisations in men; it is the only currently-available system which integrates a guidewire into a standard Foley catheter.
The intended place in therapy would be instead of cystoscopy and supra-pubic catheterisation methods after standard catheterisation has failed, or when it is difficult, such as in men with an enlarged prostate.
What’s more, the device could potentially be used in any healthcare setting by appropriately-trained staff.
The briefing looks at evidence summarised in two conference abstracts reporting prospective non-comparative studies including a total of 157 patients in a UK setting.
They show that the Urethrotech UCD can be a useful urethral catheterisation method in men, and reported no adverse events.
But uncertainties remain as the evidence base is still developing.
“Although the available non-comparative studies reported technical success with the device, most men in the studies had the Urethrotech UCD as a first-line catheterisation method. The current studies are available only as abstracts and so they present limited detail”, says the briefing.
The cost of the Urethrotech UCD is £198.98 per unit and training costs are an additional £290 per person, which is waived if the clinician subsequently trains others.
The resource impact may be less than standard care if the Urethrotech UCD avoids the need for more-complex and costly cystoscopy and suprapubic catheterisations as second-line procedures.
To read the full briefing, click here.