Advice
The technology
The technology
The TUC (transurethral catheter) Safety Valve (Class Medical) is a single-use device consisting of a proximal female luer lock, a flow restrictor, pressure value and a distal male luer slip.
It's designed to be used with a Foley catheter during transurethral catheterisation, to prevent the retaining balloon inflating if it is still in the urethra rather than the bladder.
Once the urinary catheter is inserted, the TUC Safety Valve's female luer lock is fitted to the syringe and the male luer slip to the balloon inflation port of the catheter. The catheter retaining balloon is then inflated as normal, allowing 10 to 15 seconds longer because the device causes it to take longer to inflate.
If the balloon is accidentally placed in the urethra, the pressure valve is activated. Any fluid pushed into the catheter at that point leaks out of the TUC Safety Valve and balloon inflation stops, indicating that the balloon is not inside the bladder. At this point the balloon should be deflated, fluid drawn back into the syringe, and the catheter repositioned in the bladder. When it is correctly positioned in the bladder, the TUC Safety Valve deactivates, allowing fluid to pass and the balloon to inflate.
If the valve is activated, it's important to make sure the syringe has the correct volume of saline or fluid to allow the recommended inflation of the catheter balloon as instructed by the manufacturer. Once the balloon is inflated in the bladder, the TUC Safety Valve and syringe should be immediately disconnected. Failure to do so may result in the catheter balloon deflating and the catheter migrating or getting lost.
Innovations
The device is claimed to be the only one on the market that prevents accidental inflation of the catheter in the urethra. It could improve standard care by avoiding urethra trauma and complications from it such as urethral bleeding, urethral stricture disease, and, in some cases, death.
Current care pathway
Transurethral catheterisation is commonly used for bladder drainage and urine collection in a range of conditions.
Men with acute urinary retention should be immediately catheterised. Urinary catheters are also routinely used for some types of surgery.
Bladder catheterisation (intermittent or indwelling urethral or suprapubic) should also be considered for women who have persistent urinary retention that is causing incontinence, symptomatic infections or renal dysfunction, if it cannot be corrected any other way. Intermittent urethral catheterisation in women with urinary retention who can be taught to self-catheterise or who have a carer who can perform the technique.
The following publications have been identified as relevant to this care pathway:
Population, setting and intended user
The technology would be used for anyone who needs transurethral catheterisation, usually someone who has difficulty passing urine. Transurethral catheterisation is a common procedure done in hospitals and in the community by doctors and nurses. The company estimates the qualifying population for the technology would be more than 500,000 men a year.
Costs
Resource consequences
A study by Davis et al. (2016) done at 2 tertiary referral hospitals in Dublin over 6 months in 2015 found 37 incidences of traumatic catheterisation, a rate of 6.7 per 1,000 catheters inserted. Thirty (81%) had complications as a result which they costed at 335,377 Euros, around 61 Euros per catheter inserted, or 122 Euros for those inserted into male patients (information provided by the company based on all complications occurring in men, who were half of the total population; this information is not in the published paper so could not be confirmed). This figure did not include costs from long-term complications, repeated urological interventions and follow-up appointments, and so was considered conservative.
A separate study, Davis et al. (2020), provided longer-term follow-up data on these patients (mean 37 months) and found that 29 (78%) developed urethral stricture disease in this period. One death was directly related to severe progressive urosepsis provoked by the inflation of the catheter balloon in the urethra. The cost of these complications is not provided, and it's possible that some patients could have had undiagnosed urethral stricture disease before their traumatic catheterisation. It is not clear if these rates, costs and findings would apply directly to the NHS.
The device is not currently in use in the NHS. It is a simple, easy to use device that requires no new, or changes to existing, infrastructure. Training requirements are minimal.