Sonata system for diagnostic imaging and treatment of symptomatic uterine fibroids

The technology described in this briefing is the Sonata system. It is used for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids. Fibroids are benign tumours that develop within the uterine wall and are one of the most common gynaecological problems in the UK. NICE's interventional procedures guidance on transcervical ultrasound-guided radiofrequency ablation for symptomatic uterine fibroids recommends the procedure should only be used with special arrangements for clinical governance, consent and audit or research.

The innovative aspects are that it is an incisionless treatment option that combines a high‑resolution intrauterine ultrasound probe with a radiofrequency ablation handpiece in a single delivery system.

The intended place in therapy would be in place of more invasive surgery such as hysterectomy, myomectomy, or procedures such as uterine artery embolisation in people with symptomatic uterine fibroids.

The main points from the evidence summarised in this briefing are from 6 studies. This includes 1 systematic review and meta‑analysis, 3 prospective single‑arm cohort studies, a pooled subgroup analysis from 2 of these prospective studies and 1 retrospective single‑arm cohort study. The studies included a total of 1,320 people with uterine fibroids (of whom 234 had treatment with the Sonata system). They show that Sonata may provide effective treatment of uterine fibroids, and that most people were satisfied with treatment. Sonata was not compared with any other treatment.

Key uncertainties around the evidence or technology are that there is no long-term clinical outcomes data directly comparing the technology with standard care. Also, the efficacy of the technology in people who want to have children in the future is uncertain.

The cost per procedure with the Sonata system is estimated by the company as £2,795 for an outpatient procedure or £3,403 for a day‑case surgery (excluding VAT). The average cost of standard care, assumed to be myomectomy (open or laparoscopic) or hysterectomy, is estimated as £3,664 (based on NHS reference costs 2018/19).