Faecal incontinence occurs when a person cannot control their bowel movements. Various materials (bulking agents) can be injected into the anal sphincter (the muscles around the anus that control when it opens), with the aim of making the sides of the sphincter bulkier and giving it extra strength.

The National Institute for Health and Clinical Excellence is examining injectable bulking agents for faecal incontinence 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 injectable bulking agents 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 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• The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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: 28 November 2006
Target date for publication of guidance: February 2007

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 injectable bulking agents for faecal incontinence does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research.

Clinicians wishing to inject bulking agents for the treatment of faecal incontinence should take the following actions.

• Inform the clinical governance leads in their Trusts.
• Ensure that patients understand the uncertainty about the procedure's safety and efficacy and provide them with clear written information. In addition, use of the Institute's information for patients ('Understanding NICE guidance') is recommended (available from www.nice.org.uk/IPGXXXpublicinfo). [[details to be completed at publication]]
• Audit and review clinical outcomes of all patients receiving injectable bulking agents for faecal incontinence (see section 3.1).

The procedure should only be performed in units specialising in the assessment and treatment of faecal incontinence and in the context of a clinical trial or thorough audit data collection with the intention of publishing the results. The Institute may review the procedure upon publication of further evidence.

Faecal incontinence occurs when a person loses the ability to control their bowel movements and is unable to retain faeces in the rectum. It can be caused by a wide variety of conditions that affect either the anatomy or function of the anal sphincter. Perineal injury during childbirth is a common cause of faecal incontinence in women. Faecal incontinence can also be caused by neurological disorders such as spinal injury and multiple sclerosis, or it can result from anorectal surgery, including operations for congenital anorectal conditions, such as anorectal atresia or Hirschprung's disease. Faecal incontinence is associated with considerable physical and social disability.

Typically, first-line treatment for faecal incontinence is conservative, including antidiarrhoeal medication and pelvic floor muscle training. In patients for whom conservative treatments have been inadequate, alternatives include surgery to tighten the anal sphincter (overlapping sphincteroplasty), sacral nerve stimulation, creation of a new sphincter from other suitable muscles (for example, dynamic graciloplasty), implantation of an artificial sphincter or the creation of a permanent colostomy.

In the largest case series, 82 patients had significant improvements in continence scores compared with baseline at 6 months (p < 0.001),="" which="" was="" maintained="" at="" 12="" months="" in="" a="" subset="" of="" 42="" patients.="" similar="" results="" were="" reported="" in="" a="" case="" series="" of="" 18="" patients,="" who="" had="" a="" significant="" improvement="" in="" continence="" grading="" compared="" with="" baseline="" at="" 12="" months="" (p="0.0002)." the="" authors="" noted="" that="" the="" improvement="" in="" continence="" score="" was="" significantly="" higher="" in="" patients="" who="" received="" injections="" at="" two="" or="" more="" sites.="" in="" another="" case="" series,="" 60%="" (6/10)="" of="" patients="" reported="" improvement="" from="" baseline="" at="" 6="" weeks="" after="" the="" procedure,="" although="" only="" 30%="" (3/10)="" still="" reported="" some="" improvement="" at="" 6="">

Two studies reported on quality of life and patient satisfaction after the procedure. In the case series of 18 patients, improvement compared with baseline was reported in patient satisfaction (p = 0.053) and in all quality-of-life scales (p =0.006 0.059) at 12 months. In the second study of 82 patients, all quality-of-life domains, as measured using a faecal incontinence scale, had improved compared with baseline at a median follow-up of 6 months.

The Specialist Advisers commented that there was lack of good-quality data on the efficacy of this procedure. In particular, they noted that there was uncertainty about the duration of any possible benefits and whether repeat injections were needed to maintain this effect.

Few complications were reported in the studies. The most commonly reported complication was pain at the injection sites. In the largest case series, 7% (6/82) of patients reported some pain following the procedure. In a smaller case series, half of the patients (5/10) experienced either pain or minor ulceration at the injection site or in the anal canal lasting up until 10 weeks after the procedure; however, no other complications were reported after a change in technique. Other complications included leakage of the bulking agent in 1 of 10 patients and, in a different study, passing of the bulking agent in 2 of 18 patients.

The Specialist Advisers listed infection, pain and leakage of the bulking agent along the injection track as the main complications of the procedure. Migration of the bulking agent and rectovaginal fistula were also noted as possible complications.

It was noted a number of different agents may be used for this procedure, which makes interpretation of data difficult.

It was also noted that repeat injections can be undertaken if necessary.

This guidance requires that clinicians undertaking the procedure make special arrangements for audit. The Institute 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.

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

• 'Interventional procedure overview of injectable bulking agents for faecal incontinence', May 2006.