Appraisal Consultation Document: Fluid-filled thermal balloon and microwave endometrial ablation techniques for heavy menstrual bleeding


Appraisal Consultation Document

Fluid-filled Thermal Balloon and Microwave Endometrial Ablation Techniques for Heavy Menstrual Bleeding

The Department of Health and the Welsh Assembly for Government have asked the National Institute for Clinical Excellence (NICE or the Institute) to conduct an appraisal of 'endometrial ablation techniques for heavy menstrual bleeding' and provide guidance on their use to the NHS in England and Wales. The Appraisal Committee has had its first meeting to consider both the evidence submitted and the views put forward by the representatives nominated for this appraisal by professional organisations and patient/carer and service user organisations. The Committee has developed preliminary recommendations on the use of thermal balloon and microwave endometrial ablation techniques for heavy menstrual bleeding.

This document has been prepared for consultation with the formal consultees. It summarises the evidence and views that have been considered and sets out the preliminary recommendations developed by the Committee. The Institute is now inviting comments from the formal consultees in the appraisal process (the consultees for this appraisal are listed on the NICE website).

Note that this document does not constitute the Institute's formal guidance on this technology. The recommendations made in Section 1 are preliminary and may change after consultation.

The process the Institute will follow after the consultation period is summarised below. (For further details, see the Guide to the Technology Appraisal Process on the Institute's website).

  • The Appraisal Committee will meet again to consider the original evidence and this Appraisal Consultation Document in the light of the views of the formal consultees.
  • At that meeting, the Committee will also consider comments made on the document by people who are not formal consultees in the appraisal process.
  • After considering feedback from the consultation process, the Committee will prepare the Final Appraisal Determination (FAD) and submit it to the Institute.
  • Subject to any appeal by consultees, the FAD may be used as the basis for the Institute's guidance on the use of the appraised technology in the NHS in England and Wales.

The key dates for this appraisal are:

Closing date for comments: Tuesday 6 May 2003
Second Appraisal Committee meeting: Thursday 15 May 2003

Details of membership of the Appraisal Committee are given in Appendix A and a list of the sources of evidence used in the preparation of this document is given in Appendix B.

Note that this document does not constitute the Institute's formal guidance on these technologies. The recommendations made in Section 1 are preliminary and may change after consultation.


1 Appraisal Committee's preliminary recommendations

Fluid-filled thermal balloon endometrial ablation and microwave endometrial ablation are recommended as treatment options for women with heavy menstrual bleeding for whom surgical intervention is considered appropriate.


For heavy menstrual bleeding, the choice of surgical treatment should be made jointly by the woman and the clinician responsible for treatment. The decision should be made after an informed discussion between the clinician and the woman; this discussion should take into account the desired outcome of the treatment (such as normal menstrual bleeding [eumenorrhoea] or complete cessation of menstrual bleeding [amenorrhoea]), the relative benefits of the available options and the adverse events associated with them, as well as the clinical condition, anatomical suitability and preferences of the woman.


2 Clinical need and practice

Heavy menstrual bleeding (HMB, also known as menorrhagia) is a significant cause of morbidity in premenopausal women in England and Wales. HMB is objectively defined as menstrual blood loss of more than 80 ml per cycle, or menstrual bleeding lasting longer than 7 days, over several consecutive cycles. However, in practice, the diagnosis is based on the woman's subjective assessment of blood loss.


HMB is a common disorder. It is estimated that 1 in 20 women in the UK aged 30-49 years consults her GP each year with HMB, approximately 1.5 million women in England and Wales. Referrals for menstrual disorders account for about 20% of all referrals to specialist gynaecology services, placing a significant burden on secondary healthcare services.


Many women who are referred to secondary care for HMB will eventually undergo hysterectomy. More than 47,000 hysterectomies were done in the NHS in England in 2000-2001. It is estimated that HMB was the presenting complaint in about half of these cases. Furthermore, about half of all women who have a hysterectomy for HMB are believed to have a normal uterus removed.


HMB has adverse implications for quality of life. Women with HMB may have difficulties with daily activities such as work, social activities, hobbies and holidays. Many women report anxiety, depression, embarrassment and problems in their sex lives as a result of HMB. Anaemia is also common amongst women with HMB, and this may further impair quality of life.


Diagnosis of HMB is complex and is usually based on subjective evaluation of blood loss by the affected individuals. The blood loss can be estimated by using pictorial blood-loss assessment charts (PBACs); this method takes into account the number of items of sanitary wear used and the degree of staining of each item. Although the 'gold standard' method of measuring blood loss is the alkaline haematin technique, which requires women to collect their used sanitary wear, this technique is rarely used outside research settings.


The cause of HMB is not known in the majority of cases, in which no pelvic or organic pathology is identified. However, HMB may be due to structural organic causes such as fibroids, adenomyosis, polyps, infections, precancerous conditions or haematological disorders.


Treatment of HMB aims to reduce menstrual loss and hence to improve the quality of life of the individuals. First-line treatment is drug therapy. The most commonly used drugs are tranexamic acid (an antifibrinolytic drug), mefenamic acid (a non?steroidal anti-inflammatory drug) and combined oral contraceptives. The Royal College of Obstetricians and Gynaecologists' (RCOG) guidelines recommend that drug treatment should be given for at least three cycles before considering another treatment option. Another alternative that may be considered before surgical intervention is a progesterone (levonorgestrel)-releasing intrauterine device.


Surgical treatment is usually offered to patients who do not respond to drug treatment. Hysterectomy (removing the uterus as a whole or in part) is the only treatment for HMB that guarantees amenorrhoea (complete cessation of menstrual periods), but it is associated with peri- and postoperative complications. One in 30 women suffers from perioperative adverse events, and at least 1 in 10 women experiences postoperative complications including incontinence and other urinary problems, fatigue, infection, pelvic pain, hot flushes, dry vagina and sexual problems. The procedure has a mortality rate of 0.4-1.1 per 1000 operations. Hysterectomy is costly and it has significant resource implications because it requires general anaesthesia, long operating theatre times and up to 7 days hospital stay after the operation. Full recovery may take 1-3 months.


First-generation endometrial ablation (EA) techniques were introduced almost 20 years ago as alternatives to hysterectomy. These techniques aim to reduce the menstrual bleeding by destroying (ablating) the whole thickness of the innermost layer of the uterus (the endometrium) and some of the underlying muscular layer (the myometrium) by using electrical, thermal or laser energy. EA techniques do not guarantee amenorrhoea, but are less invasive and require fewer resources than hysterectomy. Preoperative medical therapy is given to suppress endometrial growth because ablation is more likely to be successful if the endometrium is thin. All organic and structural causes of HMB should be excluded before considering EA, by any means, as a treatment option.


The most widely used first-generation EA techniques are transcervical resection of endometrium (TCRE) using a loop diathermy electrode, and roller-ball ablation (RB) using an electrode with a movable ball or cylinder. All first-generation EA techniques require direct visualisation of the endometrium using a hysteroscope. The success rates of these techniques depend heavily on the skills and experience of the operator.


Possible perioperative adverse effects with the first?generation EA techniques include electrosurgical burns, uterine perforation, haemorrhage, gas embolism, infection and fluid overload (which may cause congestive cardiac failure, hypertension, haemolysis, coma and death). The incidences of complications following first?generation EA ablation techniques were reported by the MISTLETOE study (of more than 10,000 women) in England and Wales and the Scottish Audit of Hysteroscopic Surgery (of around 1000 women). The rate of emergency hysterectomy was 6.6 per 1000 procedures in the MISTLETOE study and 2.0 per 1000 procedures in the Scottish Audit, and blunt uterine perforation was reported in 14.7 per 1000 procedures and 11.2 per 1000 procedures respectively. Combining the two audits, the mortality from the first-generation EA methods was shown to be 0.26 per 1000 procedures.


3 The technologies

The second-generation EA techniques have been introduced with the aim of providing simpler, quicker and more effective treatment options for HMB compared with first-generation EA techniques and hysterectomy. These techniques are much less dependent on the skill of the surgeon than are the first-generation techniques, but they rely heavily on the devices themselves to ensure safety and efficacy. The second-generation EA techniques include fluid-filled thermal balloon EA (TBEA), radiofrequency (thermoregulated) balloon EA, hydrothermal EA, 3D bipolar radiofrequency EA, microwave EA (MEA), diode laser hyperthermy, cryoablation and photodynamic therapy. The most frequently used second-generation EA techniques in UK clinical practice are fluid-filled TBEA and MEA. Often, these techniques do not require direct visualisation of the uterine cavity, and can be carried out under either local or general anaesthesia.


TBEA destroys the inner layers of the uterus by transferring heat from heated liquid within a balloon that is inserted into the uterine cavity. The two devices available in the UK, Cavaterm and Thermachoice, both involve an electronic controller, a single-use latex or silicone balloon catheter housing a heating element and two thermocouples, and an umbilical cable. TBEA cannot be used on women with large or irregular uterine cavities because the balloon must be in direct contact with the uterine wall to cause ablation. Cavaterm is contraindicated for women whose uterine cavity is more than 10 cm long (from the internal os to the fundus), and Thermachoice for women whose uterine cavity is more than 12 cm long, and for those who have a latex allergy. The use of endometrial thinning agents before TBEA is not recommended.


The MEA technique uses microwaves (at a fixed frequency of 9.2 GHz) to destroy the uterine glandular lining, using a hand?held applicator (microwave probe), which is inserted into the uterine cavity. The Microsulis MEA system consists of a system console that houses a control module with an embedded computer, a microwave generator, and a power supply. Additional components are a hand-held applicator, a pneumatic footswitch, coaxial and data cables, a printer (optional), a power cord, and a portable trolley.


The MEA applicator must be cleaned and sterilised before each use. MEA can be used in women whose uterine cavity is irregular in shape as a result of mild to moderate fibroids or polyps. MEA is contraindicated where there has been previous uterine surgery and where previous classic (vertical) Caesarean section has left a scar where the uterine wall is less than 8 mm thick.


Although TBEA and MEA devices have been improved over time, equipment failures are still not uncommon. Adverse events for second?generation EA techniques include uterine infection, perforation, visceral burn, bleeding, haematometra, laceration, intra-abdominal injury and cyclical pain. Women who do not respond to initial EA may require further ablations or, eventually, hysterectomy.


The Cavaterm and Thermachoice control unit/generators cost £3990 and £6000 respectively, and the disposable balloon catheters cost £280 and £350 respectively. The Microsulis MEA system costs around £40,000 (with an additional £5000 per annum for the maintenance contract). However, most centres in the UK have a 'placement arrangement' with Microsulis, under which centres pay £375 per treatment.


4 Evidence and interpretation
  The Appraisal Committee considered evidence from a number of sources (see Appendix B).
4.1 Clinical effectiveness

A total of thirteen publications relating to seven trials were identified by literature searches. One of the trials compared MEA with TCRE/RB, and six compared TBEA with TCRE, with RB, or with both. Two of these trials had a non?randomised, controlled design, and the rest were randomised controlled trials (RCTs). In addition, one manufacturer provided the translation of a small trial, published in German, that compared TBEA with RB, and another unpublished RCT comparing TBEA with TCRE - this was submitted in confidence. Another manufacturer also provided details of an RCT, comparing MEA with RB, that it conducted as part of its submission to the US Food and Drug Administration (FDA). In summary, ten trials (two MEA and eight TBEA trials) were included in this review.

  Microwave endometrial ablation (MEA)

Amenorrhoea was reported as a clinical outcome in two MEA trials. In one trial, amenorrhoea at 12 months was reported for a median of 40% of women undergoing MEA compared with 40% undergoing RB. At 36 months follow up, the median amenorrhoea rates were 47% versus 41% respectively (p = 0.19). The other trial reported similar median values for amenorrhoea at 12 months (55% in MEA versus 46% in RB, p = 0.106).


One trial reported that at 12 months 87% of women who had undergone MEA and 83% of women who had undergone RB had normal bleeding levels, defined as a PBAC score of less than 76. The difference was not statistically significant (p = 0.359). Another trial that compared MEA with TCRE/RB reported a median bleeding score of three in both groups at 12 months, which fell at 24 months to one for the MEA group and zero for the TCRE group. This bleeding score is the sum of the daily scores reported by the women, who were asked to grade the heaviness of their period on a five-point scale for each day of their period. The differences were not statistically significant.


Only one trial, which compared MEA with TCRE/RB, reported bleeding patterns in terms of the length and severity of bleeding. At 12 months 6% of the MEA group and 5% of the TCRE/RB group had more than 3 days of heavy bleeding (2% MEA, 5% TCRE/RB at 24 months) and 11% of women in the TBEA group required at least double their usual sanitary protection compared with 12% in the TCRE/RB group (7% TBEA, 13% TCRE/RB at 24 months). The differences between the groups were not statistically significant.


Two MEA trials reported patient satisfaction. In one trial, 69% of both MEA and TCRE/RB groups were totally or generally satisfied at 12 months, and 74% of those undergoing MEA and 64% of those undergoing TCRE/RB were totally or generally satisfied at 24 months. The differences between groups were not statistically significant, but the study was underpowered to detect whether this observed clinically important difference of 10% could have arisen by chance. Another trial, which compared MEA with RB, reported that 98% of women undergoing MEA were very satisfied or satisfied at 12 months compared with 99% of those undergoing RB ablation.


One trial used the SF-36 questionnaire to examine the impact of MEA and TCRE on quality of life. Following treatment, compared with baseline, six of the eight items improved significantly in the MEA group, and seven items improved significantly in the TCRE group.


Although the duration of procedures was defined inconsistently in the trials, MEA procedures took less time than TCRE and/or RB. In one trial, the mean operating time was 11.4 minutes for MEA and 15.0 minutes for TCRE/RB (p < 0.001). The other trial reported 'anaesthesia times' of 39.3 minutes for MEA and 47.1 minutes for RB, and 'treatment times' of 3.5 minutes for MEA and 20.3 minutes for RB. These differences were all statistically significant at the p < 0.01 level.


One trial reported that 8% of women in the MEA group had undergone further ablation or hysterectomy at 12 months (6% hysterectomy, 1% TCRE and 1% other ablation), and 8% of women in the TCRE plus RB group had undergone hysterectomy but none of this group had undergone further ablation. The difference was not statistically significant. Another trial reported that 1 out of 209 women in MEA group and 1 out of 106 women in RB group had undergone hysterectomy after 12 months, and none required further ablation.

  Thermal balloon endometrial ablation (TBEA)

Amenorrhoea was reported as a clinical outcome in five TBEA trials. Amenorrhoea at 12 months was reported to range between 10% and 40% for TBEA, and between 17% and 30% for TCRE/RB. Only in one trial were the differences statistically significant (14% for TBEA versus 22% for RB, p < 0.05). At 36 months, 13% of women undergoing TBEA and 21% of women undergoing RB had amenorrhoea, and at 60 months 10% of women undergoing TBEA and 14% of those undergoing RB had amenorrhoea. These results are for intention-to-treat populations.


Four TBEA trials reported changes in PBAC score. One trial, which compared TBEA with RB, reported that at 12 months 73% of the TBEA and 70% of the RB group had normal bleeding levels, defined as a PBAC score of less than 100. Another trial reported that 71% of the TBEA and 79% of the RB group had normal bleeding levels at 12 months, defined by a more stringent criterion (that is, a PBAC score of less than 76). This second study reported mean PBAC scores of 41.1 in the TBEA group and 40.2 in the RB group (mean score reductions of 343.2 and 345.5, respectively). Another trial did not report actual PBAC scores, but stated that these were significantly better for the TBEA group compared with the RB group at 24 months (p = 0.01), although not at 6 or 12 months. This trial measured treatment success as a postoperative PBAC score of less than 185, and 78% of women in the TBEA group and 76% of women in the TCRE group achieved this at 24 months. Results from the fourth trial were submitted to the Institute in confidence.


At 24 months, between 5 and 8% of patients who had undergone TBEA, and between 9 and 15% of those who had undergone TCRE or RB were still experiencing HMB. At 60 months, these figures were 2% for the TBEA group and 1% for the TCRE or RB group. No trial reported statistically significant differences between the groups for recurrent HMB.


Six TBEA trials reported patient satisfaction. Of those, five reported non-significant differences in patient satisfaction between TBEA and TCRE and/or RB groups. The proportion of women who were 'satisfied' and 'very satisfied' with the treatment ranged between 79% and 100% in TBEA groups, and between 54% and 100% in TCRE and/or RB groups at 12 months. The trial with the longest follow up reported that 42% of women in the TBEA group and 44% of women in the RB group were satisfied at 60 months (intention-to-treat populations). Only one trial reported statistically significant differences between the TBEA and the TCRE and/or RB groups. In this trial 43% of women undergoing TBEA evaluated the treatment outcome as 'excellent' at 12 months compared with 24% of women undergoing TCRE and RB. These figures were 35% and 4% respectively at 24 months.


Five trials consistently reported shorter procedure times for TBEA compared with TCRE and/or RB. Of those, two studies reported the percentages of operations that took less than 30 minutes. For TBEA these percentages were 65% and 100%, and for TCRE or RB they were 24% and 53% respectively. These differences were significant in both studies (p < 0.05). The mean operating times were between 11.5 minutes and 24 minutes in the TBEA groups compared with 37 minutes and 45 minutes in the TCRE and/or RB groups. The differences were statistically significant in all trials.


Six trials reported on the proportion of women who required further intervention. At 12 months, between 1% and 10% of women in the TBEA group required further interventions compared with between 2% and 16% in the TCRE and/or RB groups. In one trial, 5% of women undergoing TBEA and 10% of women undergoing TCRE plus RB had had an additional procedure, and these percentages rose to 6% and 15% respectively at 24 months. This difference in the repeat surgery rate was statistically significant (p < 0.01). In the trial with the longest follow-up period, repeat procedures had been done for 15 of the 76 women (19.7%) in the TBEA group (13 hysterectomies and two repeat ablations), compared with 9 of 71 women (12.6%) in the RB group (seven hysterectomies, two repeat ablations, and one dilatation and curettage) at 60 months.

4.2 Cost effectiveness

Only one published study was identified. In addition, three economic analyses were made available to the Institute as part of manufacturers' submissions, and the Assessment Group developed its own model.


The published study compared the costs of vaginal hysterectomy, TBEA and RB in 147 women in France. The total costs for each treatment group were calculated 24-36 months after the surgery, taking into account the subsequent resource use only (for example, re-interventions). The total costs were estimated to be around £3670 for vaginal hysterectomy, £870 for TBEA and £910 for RB (?5321, ?1263 and ?1320 respectively, converted to pounds sterling at 2003 rates).


The Microsulis model suggested that MEA is less costly and more effective than other EA ablation techniques, and therefore is a dominant strategy. However, hysterectomy was more effective, but more costly than MEA, at an incremental cost-effectiveness ratio (ICER) of around £4600 per quality-adjusted life-year (QALY).


The Cavaterm model estimated that TBEA is cost saving when compared with hysterectomy or other EA techniques. Cost per treatment success was £767 for Cavaterm, £828 for Thermachoice, £865 for TCRE or RB, and £2050 for hysterectomy, based on RCT data only.


The Thermachoice model, which used the cost estimates from the published French study (see Section 4.2.2), concluded that TBEA is less costly and less effective when compared with TCRE and hysterectomy. The ICERs for hysterectomy and TCRE when compared with TBEA were £1197 (?1736) and £950 (?1378) per additional woman with amenorrhoea, £13,648 (?19,789) and £11,552 (?16,751) per additional woman with eumenorrhoea or less, and £9,748 (?14,135) and £18,379 (?26,650) per additional satisfied patient respectively.


The Assessment Group's model was a Markov model, which examined the progress of six hypothetical cohorts of women with HMB treated separately by TBEA, MEA, TCRE, TCRE and RB, RB, or hysterectomy. The model took the perspective of the NHS and calculated incremental cost utility between different treatment options over 10 years. This model concluded that the second-generation techniques (that is, MEA and TBEA) are more cost effective than the first-generation techniques (that is, TCRE and/or RB). Although base?case analysis showed that TBEA dominated MEA (in other words TBEA was less costly and more effective than MEA), the overall differences in costs and utilities were negligible, and moreover the results were sensitive to small changes in utility values. Both TBEA and MEA were less costly but less effective than hysterectomy. The ICER of hysterectomy versus second-generation EA techniques was around £2000 per QALY in the base-case analysis.

4.3 Consideration of the evidence

The Committee reviewed the data available on the clinical and cost effectiveness of TBEA and MEA, having considered evidence on the nature of the condition and the value placed on the benefits of these treatments from women with HMB, those who represent them, and clinical experts. It was also mindful of the need to take account of the effective use of NHS resources.


Based on the available evidence on the effectiveness of TBEA and MEA, the Committee concluded that TBEA and MEA are likely to be as effective as first-generation EA techniques in terms of achieving normal menstrual bleeding patterns in women with HMB. However, the Committee considered that there was not sufficient evidence to differentiate between TBEA and MEA in terms of their overall effectiveness.


Having reviewed the economic models submitted to the Institute, the Committee concluded that TBEA and MEA are cost?effective treatment alternatives for HMB. The Committee was mindful of the potential advantages of TBEA and MEA: the possibility of delivering these treatments under local anaesthesia and in an outpatient setting, which might have favourable cost implications. However, the Committee concluded that in the absence of reliable effectiveness data (particularly from head?to?head trials) it was not possible to draw conclusions on the relative clinical and cost effectiveness of TBEA and MEA. Also, the Committee considered that the relative merits of these techniques varied greatly between individuals, which rendered differences in overall effectiveness less relevant. Therefore it concluded that these techniques may be appropriate for specific subgroups of women, and the choice between them should be made by the woman and the clinician responsible for treatment following informed discussion.


Having consulted with experts, the Committee concluded that the continued availability of first-generation EA techniques is important because for some women with HMB these techniques may remain the most appropriate options.


The Committee accepted that hysterectomy is the only option that can guarantee amenorrhoea, but considered that hysterectomy should not be offered to patients by default even when the desired outcome is the complete cessation of menstruation. The potential risks and benefits of all available options should be clearly explained to the individual. The patient and the clinician who is responsible for treatment should make the decision jointly.


5 Proposed recommendations for further research

Further good-quality studies are needed in the following areas:

  • to investigate the clinical and cost effectiveness of TBEA and MEA compared with each other, preferably in head-to-head RCTs
  • to investigate the clinical and cost effectiveness of second generation endometrial ablation techniques compared with progesterone (levonorgestrel)-releasing intrauterine devices



Preliminary views on the resource impact for the NHS


This section outlines the Appraisal Committee's preliminary assessment concerning the likely impact on NHS resources if the recommendations in Section 1 were to be implemented. When guidance is issued, this section is intended to assist NHS planners and managers in its implementation. Therefore the Institute particularly welcomes comments and information from those who would be involved in the implementation of the guidance so that this section can be made as helpful and robust as possible.


The impact of second-generation endometrial ablation techniques on the NHS budget will depend on the number of women eligible for each technique and the uptake rates, which will be highly influenced by the patients' and clinicians' preferences.


It is estimated that around 26,000 hysterectomies are performed in the UK each year for HMB and a further 16,000 EAs are carried out, of which about 2000 are performed using second-generation techniques. The Assessment Group estimated that if all hysterectomies were replaced by EA, the annual cost saving would be £29 million, assuming half of the procedures were replaced by first-generation techniques, and the remaining half were equally split between TBEA and MEA. Under a hypothetical scenario of all hysterectomies being replaced by second-generation EA techniques, the cost saving would be more than £32 million per annum. However, these figures represent ceilings of the potential cost savings, and it is highly unlikely that all hysterectomies for HMB will be replaced by EA, because hysterectomy will remain the most appropriate option for some women. Also, it is unlikely that such savings would be realised in financial terms for two reasons: the estimates represent amounts of resources that would remain within the system (but might nevertheless be redeployed); and the estimates are based on average costs (for example, of days in hospital avoided), some of which are fixed and therefore would not be saved, but could be available for other purposes.


7 Proposals for implementation and audit

This section presents proposals for implementation and audit based on the preliminary recommendations for guidance in Section 1.


All clinicians who care for women with HMB should review their current practice and policies to take account of the guidance set out in Section 1.


Local guidelines, protocols or care pathways that refer to the care of women with HMB should incorporate the guidance.


To measure compliance locally with the guidance, the following criteria could be used. Further details on suggestions for audit are presented in Appendix C.


A woman with HMB for whom surgical intervention is considered appropriate is offered TBEA or MEA as a treatment option.


The woman and the clinician responsible for treatment decide jointly on the choice of surgical treatment for HMB after an informed discussion.


Local clinical audits on the care of women with HMB could also include measurement of compliance with accepted clinical guidelines or protocols.


8 Related guidance

The following technologies are part of the Institute's ongoing Interventional Procedures Programme

  • Interventional Procedures Guidance, Procedure 65, Microwave endometrial ablation: due to be issued Autumn 2003
  • Interventional Procedures Guidance, Procedure 99, Balloon thermal endometrial ablation: due to be issued Autumn 2003.


9 Proposed date for review of guidance

The review date for a technology appraisal refers to the month and year in which the Guidance Executive will consider any new evidence on the technology, in the form of an updated Assessment Report, and decide whether the technology should be referred to the Appraisal Committee for review.


It is proposed that the guidance on this technology is reviewed in June 2006.


Professor David Barnett

Chairman, Appraisal Committee

April 2003


Appendix A. Appraisal Committee members

The Appraisal Committee is a standing advisory committee of the Institute. Its members are appointed for a 3-year term. A list of the Committee members who took part in the discussions for this appraisal appears below. The Appraisal Committee meets twice a month other than in December, when there are no meetings. The Committee membership is split into two branches, with the chair, vice-chair and a number of other members attending meetings of both branches. Each branch considers its own list of technologies and topics are not moved between the branches.


Committee members are asked to declare any interests in the technology to be appraised. If it is considered there is a conflict of interest, the member is excluded from participating further in that appraisal.


The minutes of each Appraisal Committee meeting, which include the names of the members who attended and their declarations of interests, are posted on the NICE website.


Dr Jane Adam

Radiologist, St George's Hospital, London
Dr Sunil Angris
General Practitioner, Waterhouses Medical Practice, Staffordshire
Dr Darren Ashcroft
Senior Clinical Lecturer, School of Pharmacy and Pharmaceutical Sciences, University of Manchester
Professor David Barnett (Chair)
Professor of Clinical Pharmacology, University of Leicester
Professor John Brazier
Health Economist, University of Sheffield
Professor John Cairns
Professor of Health Economics, Health Economics Research Unit, Institute of Applied Health Sciences, University of Aberdeen
Professor Mike Campbell
Statistician, Institute of General Practice & Primary Care, Sheffield
Dr Mike Davies
Consultant Physician, University Department of Medicine & Metabolism, Manchester Royal Infirmary
Dr Cam Donaldson
PPP Foundation Professor of Health Economics, School of Population and Health Sciences & Business School, Business School - Economics, University of Newcastle upon Tyne
Professor Jack Dowie
Health Economist, London School of Hygiene and Tropical Medicine
Dr Paul Ewings
Statistician, Taunton & Somerset NHS Trust, Taunton
Ms Sally Gooch
Director of Nursing, Mid-Essex Hospital Services NHS Trust, Chelmsford
Professor Trisha Greenhalgh
Professor of Primary Health Care, University College London
Dr George Levvy
Lay Representative; Chief Executive, Motor Neurone Disease Association, Northampton
Professor Philip Routledge
Professor of Clinical Pharmacology, College of Medicine, University of Wales, Cardiff
Dr Stephen Saltissi
Consultant Cardiologist, Royal Liverpool University Hospital
Mr Miles Scott
Chief Executive, Harrogate Health Care NHS Trust
Professor Andrew Stevens (Vice-Chair)
Professor of Public Health, University of Birmingham
Professor Mary Watkins
Professor of Nursing, University of Plymouth
Dr Norman Waugh
Senior Lecturer and Public Health Consultant, University of Southampton


Appendix B. Sources of evidence considered by the Committee


The assessment report for this appraisal was prepared by Peninsula Technology Assessment Group, Peninsula Medical School, Universities of Exeter and Plymouth, Wessex Institute for Health Research and Development, University of Southampton.

Garside R, Stein K, Wyatt K, et al, Fluid-filled Thermal Balloon and Microwave Endometrial Ablation Techniques for Heavy Menstrual Bleeding, 22 January 2003


The following organisations accepted the invitation to participate in this appraisal. They were invited to make submissions and comment on the draft scope and assessment report. They are also invited to comment on the ACD and consultee organisations are provided with the opportunity to appeal against the FAD.

I Manufacturer/sponsors:

  • Ethicon Ltd
  • Johnson & Johnson Medical
  • Microsulis Medical Ltd
  • Wallsten Medical SA

II Professional/specialist and patient/carer groups:

  • Department of Health
  • Medical Women's Federation
  • Royal College of General Practitioners
  • Royal College of Nursing
  • Royal College of Obstetrics and Gynaecology
  • Welsh Assembly Government
  • Women's Health
  • Women's Health Concern

III Commentator organisations (without the right of appeal):

  • Haringey Primary Care Trust
  • Melton, Rutland and Harborough Primary Care Trust
  • NHS Quality improvement Scotland

The following individuals were selected from clinical expert and patient advocate nominations from the professional/specialist and patient/carer groups. They participated in the Appraisal Committee discussions and provided evidence to inform the Appraisal Committee's deliberations. They gave their expert personal view on fluid?filled thermal balloon and microwave endometrial ablation techniques for heavy menstrual bleeding by attending the initial Committee discussion and/or providing written evidence to the Committee. They are invited to comment on the ACD.

  • Dr Mary Ann Lumsden, Reader/Honorary Consultant, Women's Health Concern
  • Margaret CP Rees, Reader in Reproductive Medicine, John Radcliffe Hospital on behalf of Women's Health Concern
  • Professor R.W. Shaw, Professor of Obstetrics and Gynaecology, Derby City General Hospital
  • Ruth Teddern, Health Information Officer, Women's Health
  • Pat Thompson, Health Information Officer, Women's Health


Appendix C. Detail on criteria for audit of the use of fluid-filled thermal balloon and microwave endometrial ablation techniques for heavy menstrual bleeding
Possible objectives for an audit

An audit on the treatment of women with heavy menstrual bleeding (HMB) could be carried out to ensure the following.

  • Thermal balloon endometrial ablation (TBEA) and microwave endometrial ablation (MEA) are being offered as treatment options.
  • Women with HMB are involved in the choice of treatment.
Possible patients to be included in the audit
An audit on the treatment of women with HMB could be carried out on women referred for surgical intervention over a suitable time period, for example 3 or 6 months.
Measures that could be used as a basis for an audit

The measures that could be used in an audit of TBEA and MEA are as follows.


Definition of Terms

1. The woman is offered TBEA and MEA as a treatment options

100% of women in the audit

A. For TBEA:

(1) the woman's uterine cavity is large or irregularly shaped

(2) the woman has a latex allergy (for Thermachoice).

B. For MEA:

(1) the woman has had previous uterine surgery

(2) a previous Caesarean section has left a uterine scar thinner than 8 mm thickness.

Clinicians will have to agree locally on how the offer of the option of TBEA or MEA is documented for audit purposes.

A large uterine cavity is > 10 cm from the internal os to the fundus for Cavaterm and > 12 cm in length for Thermachoice.

2. The woman and the clinician responsible for treatment decide jointly on the choice of treatment for HMB after an informed discussion of:

a. the desired outcome of the treatment and

b. the relative benefits of the available options and the adverse events associated with them and

c. the clinical condition and

d. the anatomic suitability of the woman for the options and

e. the woman's preferences

100% of women in the audit


Clinicians will have to agree locally on how an informed discussion is documented for audit purposes.

The clinician responsible for treatment is ordinarily the specialist gynaecologist.

A locally based audit on HMB also could include measures related to previous drug treatments for HMB and to appropriateness of the use of hysterectomy.


Calculation of compliance

Compliance (%) with each measure described in the table above is calculated as follows.


Number of patients whose care is consistent with the criterion plus number of patients who meet any exception listed


  X 100

Number of patients to whom the measure applies


Clinicians should review the findings of measurement, identify whether practice can be improved, agree on a plan to achieve any desired improvement and repeat the measurement of actual practice to confirm that the desired improvement is being achieved.

This page was last updated: 30 March 2010