3.1 NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 9 sources, which was discussed by the committee. The evidence included 1 systematic review, 2 cohort studies (6 publications), 1 case series and 1 case report. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The professional experts and the committee considered the key efficacy outcomes to be: quality of life, fibroid-related symptom score, fibroid volume, reintervention rates and future pregnancy.
3.3 The professional experts and the committee considered the key safety outcomes to be: haemorrhage, infection, uterine perforation and hospital readmission.
3.4 Patient commentary was sought but none was received.
3.5 There is some evidence of efficacy but there were no high-quality comparative studies with sufficient numbers of patients to make a definitive evaluation. Fibroids are a common condition. These considerations underpinned the committee's request for more data collection including disease-specific quality of life measures and rarer complications.
3.6 The committee was informed that the procedure may be an option for people who want to maintain their fertility but the evidence for successful pregnancy after the procedure is limited to case reports.
3.7 All the evidence reviewed was in women aged under 50.
3.8 All the evidence reviewed was on fibroid types 1, 2, 3 and 4, and 2 to 5 (transmural), using the International Federation of Gynecology and Obstetrics (FIGO) classification system.
3.9 The committee was informed that there is a limit to the size of fibroid that can be treated using this procedure.