Synergo for non-muscle-invasive bladder cancer

Technology

2.1 Synergo treats non-muscle-invasive bladder cancer (NMIBC) using a radiofrequency-induced thermo-chemotherapeutic effect (RITE). It heats the superficial layers of the bladder wall using controlled radiofrequency radiation (non-ionising microwave radiation), and flushes the bladder with a chemotherapy drug at the same time. This is referred to as thermochemotherapy. The drug solution is continuously pumped out of the bladder, cooled, and recirculated to prevent overheating. A miniature antenna in the catheter directs radiofrequency radiation at the bladder wall tissue, at a depth that does not generate heat on the outer surface of the bladder, to avoid injuring surrounding organs. Synergo aims to improve the delivery and efficacy of chemotherapy with the aim of reducing tumour recurrence and disease progression. It is another treatment option for NMIBC in addition to BCG therapy and radical cystectomy.

2.2 The technology 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 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. Synergo is CE marked as a class IIb medical device.

Care pathway

2.3 NICE has not made recommendations on the position in the NHS clinical pathway for bladder cancer of device-assisted chemotherapy treatments like Synergo.

2.4 Expert advice suggests the technology is being used in the NHS as an alternative to further intravesical treatment or cystectomy in high-risk NMIBC if:

Innovative aspects

2.5 The innovative aspects are the use of radiofrequency radiation (non-ionising microwave radiation) to deliver controlled electromagnetic energy directly to the walls of the bladder, along with instillations of the bladder with chemotherapy. This microwave-induced hyperthermia is designed to make the chemotherapy more effective.

Intended use

2.6 Synergo is intended for intermediate-risk or high-risk NMIBC. People have Synergo as outpatients in specialist centres. There is no need for general anaesthesia during treatment, but local anaesthetic lubricating gel may be used to insert the treatment catheter. Synergo is administered by healthcare professionals such as bladder cancer nurse specialists or consultant urologists trained in using Synergo, in secondary and tertiary care settings.

Costs

2.7 The total annual cost of Synergo therapy is £11,650 per patient (based on 12 treatment sessions). This includes the following costs:

For more details, see the website for Synergo.