The National Institute for Clinical Excellence is examining sacral nerve stimulation for faecal incontinence 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 sacral nerve stimulation 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 preliminary recommendation
• 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• The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.

For further details, see the Interim Guide to the Interventional Procedures Programme, which is available from the Institute's website (www.nice.org.uk/ip).

Closing date for comments: 24 August 2004

Target date for publication of guidance: November 2004

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 sacral nerve stimulation for faecal incontinence appears adequate to support the use of this procedure, provided that the normal arrangements are in place for consent, audit and clinical governance.

The procedure should only be performed in specialist units by clinicians with a particular interest in the assessment and treatment of faecal incontinence.

Indications

Faecal incontinence occurs when a person loses control of their bowel and is unable to retain faeces in the rectum. Faecal incontinence may result from dysfunction of the anal sphincter, which may be due to sphincter damage, spinal injury or other neurological disorders.

Faecal incontinence is associated with a high level of physical and social disability.

Typically, first-line treatment for faecal incontinence is conservative, such as anti-diarrheal medication and pelvic floor muscle training (including biofeedback therapy). In patients for whom conservative treatments have been unsuccessful, surgical alternatives include tightening the sphincter (overlapping sphincteroplasty), creating a new sphincter from the patient's own muscle (e.g. dynamic graciloplasty), or implanting an artificial sphincter. Some patients may require colostomy.

In patients with a weak but structurally intact sphincter, it may be possible to alter sphincter and bowel behaviour using the surrounding nerves and muscles. Sacral nerve stimulation is a treatment option for these patients. It involves applying an electric current to one of the sacral nerves via an electrode placed through the corresponding sacral foramen. Commonly, the procedure is tested in each patient over a 2- to 3-week period, with a temporary percutaneous peripheral nerve electrode attached to an external stimulator. If significant benefit is achieved, then the permanent implantable pulse generator (IPG) can be implanted.

This procedure was subject to a systematic review commissioned by the Institute. The systematic review included six case series studies reporting on 266 patients. In patients who had permanent implants, complete continence was achieved in 41-75% (19/46-12/16) of patients, whereas 75-100% (3/4-16/16) of patients experienced a decrease of 50% or more in the number of incontinence episodes. There was also evidence to suggest an improvement in the ability to defer defecation after permanent implantation. Patients also reported improvements in both disease-specific and general quality-of-life scores after the procedure. For more details, refer to the Sources of evidence (see Appendix).

Complications were reported both during the test peripheral nerve evaluation phase and after implantation. Evidence from the systematic review indicated that of 266 patients receiving test evaluation, 4% (10/266) experienced an adverse event. Fifty-six per cent (149/266) went on to receive permanent implantation. Of the patients who had permanent implants, 13% (19/149) reported adverse events. This included three patients who developed infections requiring device removal, seven patients who had lead migration requiring either relocation (five cases) or removal, and six patients who experienced pain after implantation.

Implantation techniques have been modified in recent years, with a view to reducing the occurrence of complications.

The following documents, which summarise the evidence, were considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

• Fraser C, Glazener C, Grant A et al. Systematic review of the efficacy and safety of sacral nerve stimulation for faecal incontinence [report on the internet]. Aberdeen: Review Body for Interventional Procedures; 2004. Commissioned by the National Institute for Clinical Excellence.

Available from: www.nice.org.uk/ip123systematicreview

• Interventional procedure overview of sacral nerve stimulation for faecal incontinence, November 2002

Available from: www.nice.org.uk/ip123overview