Cost-effectiveness of a novel urethral catheter safety device in preventing catheterization injuries in the UK.

Intraurethral catheter balloon inflation is a substantial contributor to significant catheter-related urethral injury. A novel safety valve has been designed to prevent these balloon-inflation injuries. The purpose of this evaluation was to assess the cost-effectiveness of urethral catheterisation with the safety valve added to a Foley catheter versus the current standard of care (Foley catheter alone). The analysis was conducted from the UK public payer perspective on a hypothetical cohort of adults requiring transurethral catheterization. A decision tree was used to capture outcomes in the first 30 days following transurethral catheterization, followed by a Markov model to estimate outcomes over a person's remaining lifetime. Clinical outcomes included catheter balloon injuries [CBIs], associated short-term complications, urethral stricture disease, life years and QALYs. Health-economic outcomes included total costs, incremental cost-effectiveness ratio, net monetary benefit (NMB) and net health benefit. Over a person's lifetime, the safety valve was predicted to reduce CBIs by 0.04 per person and CBI-related short-term complications by 0.03 per person, and nearly halve total costs. The safety valve was dominant, resulting in 0.02 QALYs gained and relative cost savings of £93.19 per person. Probabilistic sensitivity analysis indicated that the safety valve would be cost-saving in 97% of simulations run versus standard of care. The addition of a novel safety valve aiming to prevent CBIs during transurethral catheterization to current standard of care was estimated to bring both clinical benefits and cost savings.