Interventional Procedure Consultation Document - Endometrial cryotherapy for menorrhagia
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional Procedure Consultation Document
Endometrial cryotherapy for menorrhagia
The National Institute for Health and Clinical Excellence is examining endometrial cryotherapy for menorrhagia and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about endometrial cryotherapy for menorrhagia.
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: 20 December 2005
Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.
Limited short-term evidence on the safety and efficacy of endometrial cryotherapy for menorrhagia appears adequate to support the use of this procedure in carefully selected patients provided that normal arrangements are in place for consent, audit and clinical governance.
Clinicians should ensure that patients understand that there are alternative treatment options with different likelihoods of achieving complete amenorrhea. Appropriate patient selection and patient choice are both important. Use of the Institute's Information for the public is recommended (available from www.nice.org.uk/IPGXXXpublicinfo [details to be available at publication]).
|2.1.1||Menorrhagia is heavy cyclical menstrual bleeding over several consecutive cycles in a woman of reproductive years. Menorrhagia is clinically defined as a total menstrual blood loss of more than 80 ml per menstruation.|
|2.1.2||Menorrhagia has adverse implications for quality of life. Women with menorrhagia may have difficulties with daily activities such as work, family life and social activities. Many women report anxiety, depression, embarrassment and problems in their sex lives as a result of menorrhagia. Anaemia is also common among women with menorrhagia, and this may further impair quality of life.|
Patients with menorrhagia are usually treated with medication before surgery is considered. Medication may be administered orally or released into the lining of the uterus (endometrium) by a special intrauterine device. Historically, hysterectomy has been the standard surgical option for women with menorrhagia who no longer desire to maintain fertility. Alternatives to hysterectomy are minimally invasive procedures that may be performed using a hysteroscope. Hysteroscopic procedures include transcervical endometrial resection or destroying the endometrium with lasers, electrocautery, radiofrequency waves or heated saline. Non-hysteroscopic procedures include destroying the endometrium using heated saline, heated balloons, lasers, radiofrequency waves or microwaves. Non-hysteroscopic procedures are often carried out under local anaesthesia as a day admission.
|2.2||Outline of the procedure|
Endometrial cryotherapy is a non-hysteroscopic procedure that uses cold temperatures to freeze and destroy the endometrium. It can be performed under general, regional or local anaesthesia, although sometimes no anaesthesia is needed. A cryoprobe is inserted into the fundus of the uterus and cooled by perfusing it with either liquid nitrogen or a compressed gas mixture. The tip of the probe is placed first in one cornu of the uterus and then in the other, to generate an iceball that destroys the endometrial tissue. Each freeze cycle is followed by a heat (thaw) cycle, which allows the probe to be removed. Additional freeze/thaw cycles may be carried out if necessary.
In a randomised controlled trial, rates of treatment success as assessed by the reduction of menstrual bleeding to a pictorial blood loss assessment chart (PBAC) score of 75 or less in the absence of retreatment at 12 months were 67% (130/193 patients) and 73% (63/86 patients) in the cryotherapy and electroablation groups, respectively. Bleeding rates at 12 months were 12% and 7% for menorrhagia (PBAC greater than 100), and rates of amenorrhoea were 28% and 56% (PBAC score 0) in the cryotherapy and electroablation groups, respectively. In a case series of 67 women, none were amenorrhoeic during more than 3 months of follow-up (up to 18 months).
|2.3.2||Patient satisfaction ranged from 67% (22/33) at up to 18 months' follow-up in the case series, to 91% at 24 months in the randomised controlled trial.|
|2.3.3||Retreatment at 24 months was reported for 10% (18/186) of patients who had cryotherapy in the randomised controlled trial: 7% (13/186) of patients had a hysterectomy and 3% (5/186) of patients had repeat cryoablation. For more details, refer to the sources of evidence (see Appendix).|
The Specialist Advisors stated that the evidence from RCTs is limited, and that this procedure was one of a number of ablation techniques that uses different energy.
In the randomised controlled trial, uterine perforation occurred during sounding before treatment in 0.5% (1/186) of patients, and there were three serious adverse events that occurred more than 15 days after the procedure (and within 12 months). These were severe abdominal cramping (two patients) and severe vaginal bleeding (one patient). Other adverse events reported at up to 12 months' follow-up included: uterine cramping in 4% (7/186) of patients; other abdominal or pelvic pain/cramping in 14% (26/186); nausea and vomiting in 0.5% (1/186); hot flushes in 2% (3/186); vaginal infection in 4% (7/186), and urinary tract infection in 1% (2/186).
|2.4.2||In the prospective case series of 67 women, adverse events reported immediately after the procedure included urinary frequency or urgency (100%), moderate pelvic pain, dysuria and vaginal discharge (the numbers of patients were not well reported). Other less commonly reported adverse events were prolonged tiredness and perimenopausal symptoms.|
|2.4.3||The adverse events reported in the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) MAUDE database included excessive bleeding, uterine perforation bowel injury and stenosis of the cervix. For more details, refer to the sources of evidence (see Appendix).|
|2.4.4||The Specialist Advisors stated that the procedure appears to be safe, but there are no data available on the incidence of major complications. The theoretical adverse events include thermal injury to the cervix and vagina. Anecdotal adverse events include persistent discharge and endometritis.|
|2.5.1||The Committee noted that there are no long-term follow-up data.|
The Institute has issued guidance on the following procedures: microwave endometrial ablation (www.nice.org.uk/IPG007), photodynamic endometrial ablation (www.nice.org.uk/IPG047), balloon thermal endometrial ablation (www.nice.org.uk/IPG006), free fluid thermal endometrial ablation (www.nice.org.uk/IPG051), and impedance-controlled endometrial ablation (www.nice.org.uk/IPG104).
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.
Available from: www.nice.org.uk/ip317overview
This page was last updated: 04 February 2011