The Urethrotech UCD (Urethrotech) is a single-use device designed for second-line catheterisation in men after catheterisation has failed or is difficult, such as those with an enlarged prostate.
The device comprises a flexible hydrophilic Nitinol guidewire, which protrudes 50 cm from the tip of a standard 5.3 mm diameter 3-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. 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 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 The guidewire is then withdrawn and disposed of.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 (like any other urinary catheter). The Urethrotech UCD cannot be used for men with known urethral obstructions or injuries, or urorectal fistulae.
The Urethrotech UCD is the only currently available system which incorporates a guidewire within a standard Foley catheter. This is designed to allow the correct positioning of the catheter while avoiding trauma to the urethra, which can be caused by repeated attempts to insert a Foley catheter. This may allow second-line catheterisations to be done by clinical staff other than consultants, and may avoid the need for cystoscopy which needs anaesthetic.
The NICE guideline on lower urinary tract symptoms in men recommends immediate catheterization for men with acute urinary retention. Urinary catheters are also routinely used for some types of surgery. Inserting an ordinary Foley catheter may be difficult, because an enlarged prostate can distort the prostatic urethra or the external urethral sphincter muscle may contract. In 1 study done in Ireland, 6% of urology referrals were because of failed first-line catheterisation attempts in men. Of these referrals, 68% of men had significant urethral trauma because of the failed catheterisation (the number of attempts is not reported; Thomas et al. 2009). Another study done in Ireland showed that the incidence of male traumatic urethral catheterisation was 6.7 per 1,000 catheters inserted, with an average of 3.2 used per patient before referral for second-line catheterisation (Davis et al. 2016).
Second-line catheterisation is done using either cystoscopic or suprapubic catheterisation.
Cystoscopic catheterisation uses a flexible cystoscope, a thin tube with a light and camera on the end, to insert a guidewire and catheter into the bladder using anaesthetic. It is usually necessary to pierce a hole in the tip of the Foley catheter with a needle, to allow insertion of the guidewire.
Suprapubic catheterisation uses ultrasound guidance to insert the catheter directly into the bladder, through a hole in the abdomen, using anaesthetic.
Which method is used depends on clinical preference and local specialist availability. There is commonly a delay between the first failed catheterisation and these second-line methods because of a need for interventional radiology, a theatre or endoscopy suite, or admission for general anaesthetic.
The Urethrotech UCD would be used as an optional intermediate step before cystoscopy and suprapubic catheterisation methods.
The Urethrotech UCD is designed for second-line urethral catheterisation in men. This will most likely be older men with prostatic enlargement. The device may be used in any hospital setting where catheterisation is part of the acute care pathway, such as emergency departments, inpatient wards or intensive care units. It may be used by specialist nurses, nurse practitioners and junior doctors. It could also be used in the community and home settings, within an appropriate training framework, by GPs, community nurses and emergency services.
Each single-use Urethrotech UCD costs £198.98 (excluding VAT). The manufacturer offers a 2-hour training course and a video for £290; this is provided at no cost to clinicians who agree to subsequently train others in using the device.
Assuming that the device takes 5 minutes to insert, the cost of staff time for a band 8a urology nurse practitioner would be £5.16; for a band 6 urology nurse specialist this would be £3.67, and for a specialist trainee registrar this would be £3.33 (PSSRU costs 2016).
A cystoscopic catheterisation procedure costs £694 (excluding VAT) per catheterisation. An outpatient suprapubic catheterisation procedure costs £454 (excluding VAT) per catheterisation (NHS National Tariff 2017/2018). Khan and Abrams (2009) conducted a study within the NHS and estimated costs for suprapubic catheterisation as £2,400 for an inpatient case and £462 for an outpatient case (based on salaries, disposables, anaesthetic and instruments).
The cost per catheterisation with the Urethrotech UCD may be less than that for cystoscopic or suprapubic catheterisation. If it were shown to be as effective as these methods, cost savings may arise from a shorter procedure (about 5 minutes compared with 15 to 20 minutes), avoiding the need for a theatre or endoscopy suite, or even avoiding the need to cancel surgery because of failed pre-surgical catheterisations.
The Urethrotech UCD is currently being used in 1 NHS trust.