This procedure involves the use of ultrasound energy to destroy non-cancerous growths that occur in the womb known as uterine fibroids.

The National Institute for Health and Clinical Excellence is examining magnetic resonance image-guided focused ultrasound for uterine fibroids and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about magnetic resonance image-guided focused ultrasound for uterine fibroids.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

• comments on the preliminary recommendations
  
• the identification of factual inaccuracies
  
• additional relevant evidence.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
  
• The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

For further details, see the Interventional Procedures Programme manual, which is available from the Institute's website (www.nice.org.uk/ipprogrammemanual).

Closing date for comments: 27 February 2007
Target date for publication of guidance: May 2007

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

Current evidence on the safety and efficacy of magnetic resonance image (MRI)-guided focused ultrasound for uterine fibroids does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research.

Clinicians wishing to use MRI-guided focused ultrasound for uterine fibroids should take the following actions.

? Inform the clinical governance leads in their Trusts.

? Ensure that patients understand the uncertainty about the procedure's safety and efficacy and provide them with clear written information. In addition, use of the Institute's information for patients ('Understanding NICE guidance') is recommended (available from www.nice.org.uk/IPGXXXpublicinfo). [[details to be completed at publication]]

? Audit and review clinical outcomes of all patients having MRI-guided focused ultrasound for uterine fibroids (see section 3.1).

Uterine fibroids, also known as uterine leiomyomas or uterine myomas, are benign nodules of smooth muscle cells and fibrous tissue that develop within the wall of the uterus.

Uterine fibroids are common, occurring in approximately one third of all women. In most cases they are asymptomatic, but fibroids can cause symptoms such as abnormal uterine bleeding, a feeling of pelvic pressure, or pain; they may also be associated with reproductive problems such as infertility and miscarriage.

The evidence of efficacy is based on three case series. In two of the studies the primary endpoint was a 10-point reduction in symptom severity as measured by the Uterine Fibroid Symptom Quality of Life questionnaire (UFS-QOL). In one of these studies, which included 109 women, 71% achieved this outcome at 6 months, and 51% (42/82) at 12 months.

In the third case series (n = 42) menstrual bleeding duration and intensity were the primary outcome measures. Following the procedure, mean menstrual bleeding duration was reduced from 6.1 days to 4.9 days with an increase in the time interval between tampon/pad changes from 1.7 hours to 2.25 hours at a minimum follow-up of 6 months.

The Specialist Advisers stated that symptomatic response was a key efficacy outcome. One Adviser stated that there was limited reduction in fibroid volume following the procedure. Another Adviser commented that not all fibroids were suitable for this procedure.

The evidence on safety is based on three case series and one case report. In a study of 109 women, 5% reported skin burns following the procedure, with one woman developing skin ulceration. Skin burns were also reported in three of 49 (6%) women in a case series: these were small in two of the women, but a full thickness burn in one. In two studies there was one report each (1/109; 1/42) of a patient developing pain in the distribution of the sciatic nerve, which in both cases resolved within 12 months. Other complications reported included mild diarrhoea, fatigue and backache. For more details, refer to the sources of evidence (see appendix).

Fluid-filled thermal balloon and microwave endometrial ablation techniques for heavy menstrual bleeding have been appraised as part of the Institute's technology appraisal work programme and full guidance was issued in April 2004 (www.nice.org.uk/page.aspx?o=113372). The Institute has issued clinical practice guidelines on heavy menstrual bleeding (cg044).

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

• 'Interventional procedure overview of magnetic resonance image-guided focused ultrasound for uterine fibroids', November 2006 .