1.1 Current evidence on the safety of ultrasound-guided high‑intensity transcutaneous focused ultrasound for symptomatic uterine fibroids shows there are well-recognised complications including skin burns. The evidence on efficacy is limited in quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research.
1.2 Clinicians wishing to do ultrasound-guided high‑intensity transcutaneous focused ultrasound for symptomatic uterine fibroids should:
Inform the clinical governance leads in their NHS trusts.
Ensure that patients understand the procedure's safety and efficacy, as well as any uncertainties about these and provide them with clear written information to support shared decision making. In addition, the use of NICE's information for the public is recommended.
Audit and review clinical outcomes of all patients having ultrasound-guided high intensity transcutaneous focused ultrasound for symptomatic uterine fibroids. NICE has identified relevant audit criteria and has developed an audit tool (which is for use at local discretion).
1.3 During the consent process clinicians should tell patients that their symptoms may not be fully relieved and may return, and that further procedures may be needed. They should also tell patients about the risk of skin burns. Patients considering pregnancy should be told that the effects of the procedure on fertility and future pregnancy are uncertain.
1.4 Patient selection should be done by a multidisciplinary team including a gynaecologist and an appropriate imaging specialist.
1.5 The procedure should only be done in specialised centres by clinicians with specific training in this technique.
1.6 NICE encourages further research and prospective data collection. Studies comparing ultrasound-guided high-intensity focused ultrasound with other therapies such as uterine artery embolisation and MRI-guided high‑intensity transcutaneous focused ultrasound would be useful. Studies should report patient selection (including size, location and number of fibroids), patient-reported outcome measures, long-term outcomes and subsequent pregnancy rates.