TUC Safety Valve to prevent balloon inflation in the urethra during transurethral catheterisation

The technology described in this briefing is TUC Safety Valve. It is suitable for anyone aged over 16 who needs transurethral catheterisation.

The innovative aspects are that it is claimed to be the only device that eradicates the risk of urethral injury from accidentally inflating the catheter retention balloon in the urethra instead of the bladder.

The intended place in therapy would be in addition to an indwelling urinary catheter in men with urinary dysfunction and other conditions that prevent them from emptying their bladder.

The main points from the evidence summarised in this briefing are from 1 observational study including a total of 100 adult men in a tertiary referral teaching hospital. The valve activated 7 times in the study. The study shows that the TUC Safety Valve is effective at stopping accidental catheter inflation in the urethra.

Key uncertainties around the evidence or technology are that there is limited evidence on using the device in a clinical setting, no comparative evidence, and no evidence from the UK. The company plans to address this by collecting prospective audit data on the technology's use in the NHS.

Safety issues identified are that the TUC Safety Valve does not have a CE mark. However this is expected in May 2020.

The cost of the TUC Safety Valve is £15 per unit (excluding VAT). The resource impact will be in addition to standard care. This could be offset by savings from complications avoided by preventing accidental inflation of catheter balloons in the urethra. There is limited published evidence to support this.