Magnetic resonance image-guided focused ultrasound for uterine fibroids (interventional procedures consultation)
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional Procedure Consultation Document
Magnetic resonance image-guided focused ultrasound for uterine fibroids
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.
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.
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
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).
|1.3||Further research on the procedure and publication of long-term outcomes would be useful. The Institute may review the procedure upon publication of further evidence.|
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.
|2.1.3||Treatment depends on whether the fibroids are causing any symptoms, and on the woman's desire to become pregnant. Asymptomatic fibroids (often discovered incidentally) require no treatment other than monitoring. Depending on size, number and location, symptomatic fibroids can be removed surgically by hysterectomy or myomectomy. Uterine artery embolisation may also be a treatment option for some women.|
|2.2||Outline of the procedure|
|2.2.1||MRI-guided focused ultrasound is carried out with continuous image guidance and monitoring, usually under intravenous sedation. A catheter is inserted to keep the bladder empty during the procedure. Imaging is used to identify the fibroid(s), and a low-power sonication (ultrasound) is delivered into the centre of the fibroid. Once the correct positioning is confirmed, higher power consecutive sonications are delivered to the target area to ablate the fibroid tissue. A thermal mapping sequence is used during the procedure to depict the extent of the heated tissue. After treatment, imaging is again used to evaluate the area of the fibroid ablated.|
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.
|2.3.3||All three studies reported that a percentage of women (12% [6/49], 26% [11/42] and 28% [23/82]) required alternative treatments following the procedure, such as hysterectomy.|
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).
|2.4.2||The Specialist Advisers listed the potential complications as skin burns and reversible neural damage. They also commented that thermal damage to adjoining structures was a theoretical concern.|
|2.5||It was noted that there was no evidence on the efficacy of the procedure as treatment for sub-fertility associated with uterine fibroids.|
|3.1||This guidance requires that clinicians undertaking the procedure make special arrangements for audit. The Institute has identified relevant audit criteria and is developing an audit tool (which is for use at local discretion), which will be available when the guidance is published.|
|3.2||The Institute has published interventional procedures guidance on microwave endometrial ablation (www.nice.org.uk/ipg007guidance), balloon thermal endometrial ablation (www.nice.org.uk/ipg006guidance), photodynamic endometrial ablation (www.nice.org.uk/ipg047guidance), free fluid thermal endometrial ablation (www.nice.org.uk/ipg051guidance) and impedance-controlled bipolar radiofrequency ablation for menorrhagia (www.nice.org.uk/ipg104guidance).|
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).
Chairman, Interventional Procedures Advisory Committee
|Appendix:||Sources of evidence|
The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.
This page was last updated: 30 March 2010