Guidance
3 Committee considerations
The evidence
3.1 To inform the committee, 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 randomised controlled trial, 4 non-randomised comparative studies, 3 case series and 1 case report, and is presented in table 2 of the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The specialist advisers and the committee considered the key efficacy outcomes to be: patient-reported outcome measures, quality of life, fibroid size, subsequent pregnancy rates and need for further intervention.
3.3 The specialist advisers and the committee considered the key safety outcomes to be: pain, skin burns, vaginal discharge and bleeding, and damage to adjacent structures (including bowel injury).
3.4 One commentary from a patient who had experience of this procedure was received, which was discussed by the committee.
Committee comments
3.5 Most evidence reviewed by the committee came from studies done outside the UK and there was some uncertainty about the generalisability of this evidence to the UK setting.
3.6 There may be additional safety concerns in patients who have had previous abdominal surgery (including caesarean section); in patients who are obese; and in patients who have a retroverted uterus.
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