Interventional procedure consultation document

Endoscopic radiofrequency therapy of the anal sphincter for faecal incontinence

Treating faecal incontinence by applying heat energy to the anal wall

Faecal incontinence occurs when a person loses (often only partially) voluntary control of their bowel movements, resulting in leakage of faeces. The condition may relate to inadequate formation of the anus from birth. It can also relate to diseases of the nervous system (such as spina bifida, spinal cord injury, multiple sclerosis), pelvic organ prolapse, or previous pelvic surgery or radiotherapy. In women, another cause is injury to the anal canal during childbirth.

In this procedure, radiofrequency energy is applied to the anal wall, with the aim of inducing muscle changes to improve muscle tone and help control bowel movement.

The National Institute for Health and Clinical Excellence (NICE) is examining endoscopic radiofrequency therapy of the anal sphincter for faecal incontinence and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’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 endoscopic radiofrequency therapy of the anal sphincter for faecal incontinence.

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 provisional recommendations
• the identification of factual inaccuracies
• additional relevant evidence, with bibliographic references where possible.

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

The process that NICE 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• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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 NICE website (www.nice.org.uk/ipprogrammemanual).

NICE is committed to promoting through its guidance race and disability equality and equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so.

In order to help us promote equality through our guidance we would be grateful if you could consider the following question:

Are there any issues that require special attention in light of NICE’s duties to have due regard to the need to eliminate unlawful discrimination and promote equality and foster good relations between people with a characteristic protected by the equalities legislation and others?

Closing date for comments: 21 February 2011

Target date for publication of guidance: May 2011

1   Provisional recommendations

1.1  The evidence on endoscopic radiofrequency therapy of the anal sphincter for faecal incontinence raises no major safety concerns. There is evidence of efficacy in the short term, but in a limited number of patients. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research.

1.2  Clinicians wishing to undertake endoscopic radiofrequency therapy of the anal sphincter for faecal incontinence should take the following actions.

• Inform the clinical governance leads in their Trusts.
• Ensure that patients and their carers understand the uncertainty about the procedure’s efficacy and provide them with clear written information. In addition, the use of NICE’s information for patients (‘Understanding NICE guidance’) is recommended (available from www.nice.org.uk/guidance/IPGXXX/publicinfo). [[details to be completed at publication]]
• Audit and review clinical outcomes of all patients having endoscopic radiofrequency therapy of the anal sphincter for faecal incontinence (see section 3.1).

1.3  This procedure should be carried out only in units specialising in the assessment and treatment of faecal incontinence that can offer a range of treatment options.

1.4  Further research into endoscopic radiofrequency therapy of the anal sphincter for faecal incontinence should clearly define the patient groups being treated. It should also report the clinical impact in terms of quality of life and long-term outcomes. NICE may review the procedure on publication of further evidence.

2   The procedure

2.1  Indications and current treatments

2.1.1  Faecal incontinence occurs when a person loses the ability to control their anal sphincter and bowel movements, resulting in leakage of faeces. Causes include inadequate formation of the anus from birth, neurological disease, and perineal injury during vaginal delivery (a relatively common cause in women).

2.1.2  First-line treatment is conservative, with measures such as dietary management or antidiarrhoeal medication. If these are not successful, pelvic floor muscle or anal sphincter training (sometimes including biofeedback therapy) may be used.

2.1.3  In patients refractory to conservative treatment, surgical options include sphincter repair, sacral nerve stimulation, stimulated graciloplasty (creation of a new sphincter from other suitable muscles), anorectal or transabdominal implantation of an artificial anal sphincter, or permanent colostomy.

2.2   Outline of the procedure

2.2.1  The aim of endoscopic radiofrequency therapy of the anal sphincter for faecal incontinence is to cause a degree of scarring, so tightening the ring of muscle that forms the sphincter. It is intended to be less invasive than alternative surgical treatments.

2.2.2  The procedure is usually done with the patient under sedation and local anaesthesia. Under direct visualisation, a specially designed transparent catheter which houses needle electrodes is inserted into the anus. The needle electrodes deliver heat generated by radiofrequency energy to the anal sphincter muscle under temperature feedback control via temperature sensors. Radiofrequency energy is typically applied to each quadrant sequentially, starting about the level of the dentate line and repeating this at 3 to 5 levels approximately 1 cm apart, above and below the dentate line. Chilled water is used to cool the mucosa.

Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/guidance/IP/878/overview

2.3   Efficacy

2.3.1  A case series of 50 patients reported improved mean scores in all components of the Fecal Incontinence Quality of Life questionnaire (FIQL) (29 questions on lifestyle, coping, depression, and embarrassment scored from 1 to 4; higher score indicates better quality of life) from baseline to 6-month follow-up (per protocol analysis: lifestyle, 2.5 to 3.1; coping, 1.9 to 2.4; depression, 2.8 to 3.3; and embarrassment, 1.9 to 2.5; p ≤ 0.0001 for each).

2.3.2  A case series of 24 patients reported improved mean scores in the lifestyle, coping and embarrassment components of the FIQL questionnaire from baseline to 12-month follow-up (2.6 to 3, p = 0.0035; 1.6 to 2.2, p = 0.0095; and 1.3 to 2.2, p = 0.0005, respectively).

2.3.3  A case series of 19 patients reported a significant improvement in mean scores in all components of the FIQL questionnaire from baseline to 5-year follow-up (lifestyle, 2.43 to 3.16, p < 0.00075; coping, 1.73 to 2.6, p < 0.00083; depression, 2.24 to 3.15, p < 0.0002; and embarrassment, 1.56 to 2.51, p < 0.0003).

2.3.4  The case series of 50 patients reported no differences in resting or squeeze pressure, rectal sensation, pudendal nerve motor latency, or sphincter defects on endoanal ultrasound at 6-month follow-up.

2.3.5  The Specialist Advisers listed key efficacy outcomes as improvement in continence/faecal control and improved quality of life.

2.4   Safety

2.4.1  The case series of 50 patients reported mucosal ulceration in 2 patients, 2–3 weeks after treatment. In 1 patient this was superficial and settled with local care: continence was improved. In the other patient the ulceration did not involve the underlying muscle but nevertheless caused anal pain: continence was worse at 6-month follow-up.

2.4.2  The case series of 50 patients reported constipation in 2% (1/50) of patients (treatment and resolution for these events was not described).

2.4.3  The case series of 24 patients reported constipation and diarrhoea in 1 patient each. The first patient was treated with laxatives, and the diarrhoea in the second patient resolved spontaneously.

2.4.4  The case series of 50 and 19 patients reported delayed bleeding in 2% (1/50) and 32% (6/19) of patients, respectively. Both required suture ligation to control the bleeding (not otherwise described).

2.4.5  The case series of 50 patients reported postoperative anal pain in 10% (5/50) of patients.

2.4.6  The Specialist Advisers listed anecdotal adverse events to include haemorrhage (acute or delayed) and anal stenosis.

2.5   Other comments

2.5.1  The Committee recognised both the serious impact that faecal incontinence can have on quality of life and the potential benefits of new treatment options for carefully selected patients, provided that their efficacy has been properly demonstrated.

3   Further information

3.1  This guidance requires that clinicians undertaking the procedure make special arrangements for audit. NICE 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  For related NICE guidance see www.nice.org.uk

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

January 2011

_{Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.}

 _{It is the responsibility of consultees to accurately cite academic work in order that they can be validated.}