Laparoscopic uterine nerve ablation (LUNA) for chronic pelvic pain (interventional procedures consultation)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

Laparoscopic uterine nerve ablation (LUNA) for chronic pelvic pain

Pelvic pain in women can have a number of causes, including endometriosis (a condition in which tissue that is normally found lining the inside of the womb is also present outside the womb, usually in the pelvic cavity). In some patients a cause cannot be identified. Laparoscopic uterine nerve ablation (LUNA) involves the destruction of a small segment of ligament that carries nerve fibres within the pelvis.

The National Institute for Health and Clinical Excellence is examining laparoscopic uterine nerve ablation (LUNA) for chronic pelvic pain 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 laparoscopic uterine nerve ablation (LUNA) for chronic pelvic pain.

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The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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: 24 June 2007
Target date for publication of guidance: September 2007

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

1	Provisional recommendations

1.1	The evidence on laparoscopic uterine nerve ablation (LUNA) for chronic pelvic pain suggests that it is not efficacious and therefore should not be used.

The procedure

2.1

Indications

2.1.1

Chronic pelvic pain is commonly described as pain felt below the umbilicus which lasts for at least 6 months. Chronic pelvic pain includes dysmenorrhoea and dyspareunia. Secondary dysmenorrhoea describes period pain associated with an underlying problem, whereas in primary dysmenorrhoea no underlying cause is identified.

2.1.2

One of the most common causes of chronic pelvic pain is endometriosis. In this condition, tissue that is normally found lining the inside of the uterus is also present outside the uterus, usually in the pelvic cavity. Definitive diagnosis is usually by laparoscopy or laparotomy. Other causes of chronic pelvic pain include pelvic inflammatory disease, pelvic congestion syndrome, nerve entrapment, neuropathic and postsurgical pain. In some patients a cause cannot be identified.

2.1.3

Treatment for chronic pelvic pain depends on the underlying cause. Treatment strategies for endometriosis depend on several factors including the patient's age, symptoms, whether the patient wants to have children and whether there is associated subfertility. Hormonal treatments aim to stop ovulation, allowing the endometrial deposits to regress. Conservative surgery via laparoscopy or laparotomy aims to remove the endometrial deposits, usually by laser or electrocautery. Hysterectomy, with or without removal of the ovaries, may be considered for severe symptoms that do not respond to conservative treatment.

2.1.4

When the cause of chronic pelvic pain cannot be identified, conservative treatments include non-steroidal anti-inflammatory drugs or a trial of the oral contraceptive pill. If these treatments fail, surgical treatment options include vaginal uterosacral ligament resection, uterine nerve ablation (UNA) (involving transection of the uterosacral ligaments at their insertion into the cervix by open surgical operation) and presacral neurectomy (PSN) (involving total removal of the presacral nerves).

2.2

Outline of the procedure

2.2.1

Laparoscopic uterine nerve ablation (LUNA) is normally performed under general anaesthesia. The peritoneal cavity is insufflated with carbon dioxide gas and small incisions are made in the abdomen to provide access for the laparoscope and surgical instruments. The uterus is anteverted with a uterine manipulator and the uterosacral ligaments are identified and transected close to their attachment to the cervix. One or both of the ligaments may be transected. A small portion of ligament is sometimes resected and examined histologically to confirm the presence of nerve fibres. LUNA is often carried out during the course of other surgical treatment for endometriosis.

2.3

Efficacy

2.3.1

A systematic review of nine randomised controlled trials (RCTs) reported that there were no significant differences in pain relief between women treated with LUNA and controls (women treated with diagnostic laparoscopy or conservative surgery alone) at 6 months (odds ratio [OR] 1.15, 95% confidence intervals [CI] 0.66 to 1.99), 12 months (OR 1.20, 95% CI 0.72 to 1.99) or 36 months (OR 0.84, 95% CI = 0.39 to 1.80). For women with primary dysmenorrhoea, the OR for pain relief at 6 and 12 months was 1.43 (95% CI 0.56 to 3.69) and 6.12 (95% CI 1.78 to 21.03), respectively, in favour of LUNA. For women with secondary dysmenorrhoea, the OR for pain relief at 6 and 12 months was 1.03 (95% CI 0.52 to 2.02) and 0.77 (95% CI 0.43 to 1.39), respectively.

2.3.2

One RCT included in the systematic review compared laparoscopic PSN (LPSN) with LUNA. It reported that women treated with LPSN had significantly less pain at 12 months than women treated with LUNA (OR = 0.10, 95% CI 0.03 to 0.32). A non-randomised comparative study reported that 76% (25/33) of women treated with LUNA had relief of dysmenorrhoea at 6 months, compared with 91% (21/23) of women treated with LPSN (p value not stated). One RCT comparing LUNA with vaginal uterosacral ligament resection reported similar proportions of women with no chronic pelvic pain, or pain not requiring treatment at 12 months (75% [27/36] and 74% [28/38] respectively, p = 0.90).

2.3.3

In one case series of 85 women, excellent or satisfactory improvement (not otherwise defined) was reported by 76% (38/50) of women with dysmenorrhoea and 80% (41/51) of women with deep dyspareunia after a mean follow-up of 19 months.

2.3.4

One case series of 52 women reported an overall success rate (defined as a response of pain relief of 8 or higher on a scale of 0-10, no need for oral analgesics and the absence of pelvic pathology on pelvic examination) of 72% at 1 year, 58% at 2 years, 51% at 3 years and 40% at 4 years. For more details, refer to the sources of evidence (see appendix).

2.3.5

The Specialist Advisers considered that while the procedure could be considered established practice, there is uncertainty about its efficacy.

2.4

Safety

2.4.1

Few complications were reported. In one RCT and one non randomised comparative study, more complications were reported for LPSN than for LUNA. Constipation was reported in 0% (0/35) and 12% (4/34) of women treated with LUNA compared with 94% (31/33) and 21% (5/24) of women treated with LPSN (follow-up not reported). Urinary urgency, postoperative bleeding and painless labour were also reported in the LPSN groups but not the LUNA groups.

2.4.2

Two case reports described a total of five women developing uterine prolapse after having LUNA; three women were young, nulliparous soldiers undergoing parachute training and the other two women had a history of vaginal childbirth. For more details, refer to the sources of evidence (see appendix).

2.4.3

The Specialist Advisers stated that potential adverse events include vascular, bowel or ureter injury, bleeding, the need for conversion to open surgery, and prolapse.

3	*Further information*
3.1	NICE has issued interventional procedures guidance on laparoscopic helium plasma coagulation for the treatment of endometriosis (ipg171).

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
May 2007

Appendix:

Sources of evidence

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

' Interventional procedure overview of laparoscopic uterine nerve ablation (LUNA) for chronic pelvic pain', February 2007 .

Available from: www.nice.org.uk/ip376overview.

This page was last updated: 30 March 2010