The technology

Synergo is a technology known as radiofrequency-induced thermo-chemotherapeutic effect (RITE). It is designed to improve how chemotherapy is given to treat non-muscle-invasive bladder cancer. The treatment is based on controlled radiofrequency radiation (non-ionising microwave radiation) of the bladder tissue, along with instillations of the bladder with chemotherapy (thermo-chemotherapy). Synergo circulates and continuously cools the chemotherapy and flushes the bladder. At the same time a miniature antenna in the catheter emits radiofrequency radiation. The radiofrequency energy is directed at the bladder wall tissue, at a depth which goes past the superficial layer of the blood vessels but does not generate heat past the bladder. This avoids injuries to surrounding organs.

Synergo is an intravesical irrigation system combined with an energy-delivering unit. The system has a radiofrequency generator that delivers radiofrequency energy at 915 MHz (the lower limit of microwave electromagnetism). It also includes a drug circulating unit, and a microprocessor with application-specific software. The drug solution is continuously pumped out of the bladder and re-instilled after being cooled by the device. The user interface consists of a computer, monitor with touch screen, and barcode reader. The software monitors and records treatment parameters in real time during the treatment session. The patient is treated as an outpatient and there is no need for anaesthesia during treatment.

Expert advice suggests that people with high-risk non-muscle-invasive bladder cancer whose disease has not responded to Bacille Calmette‑Guérin (BCG) treatment (a form of immunotherapy), or are intolerant to BCG treatment, would be most likely to benefit from this technology.

The company noted adverse events reported include haematuria; dysuria; nocturia; pain or heat sensation during treatment; bladder spasm; urinary frequency or urgency; urethral stricture; posterior bladder wall thermal reaction. No safety issues have been reported.

Innovations

Synergo uses microwaves and infuses chemotherapy into the bladder via a catheter inserted through the urethra. The hyperthermia range is between 41°C and 44°C. This is controlled by 5 thermocouples integrated in a specially designed size 18 French treatment catheter.

Current care pathway

People diagnosed with bladder cancer would have papillary tumours removed in a transurethral resection of bladder tumour (TURBT). The pathology and the person's history indicate if they have low, intermediate or high risk. Treatment for people with a confirmed diagnosis of non-muscle-invasive bladder cancer are guided by risk classification.

Treatment includes using intravesical mitomycin C for people with intermediate-risk non-muscle-invasive bladder cancer. People should have another TURBT as soon as possible, and no later than 6 weeks after the first resection if the first TURBT shows high‑risk non‑muscle‑invasive bladder cancer. People with high-risk non-muscle-invasive bladder cancer are offered intravesical BCG or radical cystectomy.

NICE's guideline on bladder cancer: diagnosis and management is relevant to this care pathway.

NICE interventional procedures guidance on intravesical microwave hyperthermia and chemotherapy for non-muscle-invasive bladder cancer recommends this procedure should only be used with special arrangements for clinical governance, consent, and audit or research.

Population, setting and intended user

Synergo is intended to give the intravesical mitomycin C solution with local microwave-induced hyperthermia when treating people with intermediate and high-risk non-muscle-invasive bladder cancer.

The company states that Synergo could be used:

  • as first-line treatment for intermediate and high-risk non-muscle-invasive bladder cancer if BCG immunotherapy is not available

  • as second-line treatment for intermediate and high-risk non-muscle-invasive bladder cancer patients if previous treatment has failed

  • in people with high-risk non-muscle-invasive bladder cancer who cannot have or do not want to have a cystectomy

  • in people with intermediate or high-risk non-muscle-invasive bladder cancer who are either intolerant to, or cannot have, BCG immunotherapy.

The system could be set up in outpatient clinics. It is most likely to be used by healthcare professionals such as bladder cancer nurse specialists in secondary and tertiary care in the NHS.

Costs

Technology costs

The Synergo system costs £9,500 (excluding VAT) per year on lease. Synergo applicators (disposable, single use) cost £7,350 per box of 15 units (excluding VAT). This results in a cost of £490 (excluding VAT) per treatment, which is the cost for consumables only.

Costs of standard care

The cost of delivering a single 40-mg dose of intravesical mitomycin C in an operating theatre will be £295 per person. This will include an administration cost of £160 (National tariff 2020/21) and £135 for the cost of mitomycin 40 mg powder and solvent for intravesical solution vials (BNF for mitomycin).

The cost of standard care for people with high-risk non-muscle-invasive bladder cancer using a white-light-guided TURBT is £1,500 per person (National tariff 2020/21). BCG is generally used for high-risk tumours and first-line treatment for carcinoma in situ, and the average total BCG treatment cost was $1,936 (equivalent to £1,490) per person (Sievert et al. 2009).

Resource consequences

Synergo has been used in 3 hospitals in the UK.

Costs include provision of the system and staff training. This includes additional refresher training or new user training when needed. Training consists of bespoke professional education on using the technology in a clinical setting. This usually takes 1 day, and a certificate is issued for completed training.

Minimal changes in facilities or infrastructure are needed because chemotherapy is routinely given in hospitals.

If adopted, the technology would be used in addition to chemotherapy. However, it could be resource releasing by improving cancer survival rates and reducing recurrence of bladder cancer.