Summary

Summary

  • The technology described in this briefing is Synergo. Synergo uses radiofrequency-induced thermo-chemotherapeutic effect (RITE) to give chemotherapy (mitomycin C, MMC). It is a treatment for non-muscle-invasive bladder cancer.

  • The innovative aspects are that it uses radiofrequency radiation (non-ionising microwave radiation) to deliver controlled electromagnetic energy directly to the walls of the bladder. It then infuses chemotherapy into the bladder via a catheter inserted through the urethra.

  • The intended place in therapy would be as an add-on intervention for treating non-muscle-invasive bladder cancer.

  • The main points from the evidence summarised in this briefing are from 3 trials and 3 observational studies including a total of 829 people with non-muscle-invasive bladder cancer. Results from 2 trials showed that there was no significant difference in disease-free survival when the group of people who had RITE given by Synergo was compared with the control group. The results of an earlier trial showed significantly higher survival rate in people who had device-assisted intravesical thermo-chemotherapy compared with those who had chemotherapy alone.

  • Key uncertainties around the evidence are that limited evidence from randomised controlled trials for the technology is available. This is because 2 trials were terminated prematurely. The evidence would benefit from well-controlled comparative studies to capture treatment clinical benefits.

  • Safety issues identified in NICE's interventional procedures guidance on intravesical microwave hyperthermia and chemotherapy for non-muscle-invasive bladder cancer include thermal bladder damage. The company noted adverse events including haematuria, pain or heat sensation during treatment and posterior bladder wall thermal reaction.

  • The cost of the Synergo System is £9,500 (excluding VAT) per year on lease. As an add-on intervention, the resource impact of using Synergo would result in additional costs to standard care. The cost of mitomycin for 40 mg of powder and solvent for intravesical solution vials is £135 (BNF for mitomycin). The cost of standard care for people with high-risk non-muscle-invasive bladder cancer using a white-light-guided transurethral resection of bladder tumour is £1,500 per person.