1.1 Current evidence on the safety and efficacy of insertion of a magnetic bead band for faecal incontinence is limited in quantity and quality. The available evidence was considered in the context of the distress that faecal incontinence can cause and of the other treatment options, which may be limited. If further evidence supports the efficacy of this procedure, it has the potential to significantly improve quality of life for appropriately selected patients. Therefore insertion of a magnetic bead band for faecal incontinence may be used with special arrangements for clinical governance, consent and audit. NICE encourages the publication of outcomes on all patients, with specific consideration of entering all eligible patients into the HTA trial – 12/35/07 (see section 1.3).
1.2 Clinicians wishing to undertake insertion of a magnetic bead band for faecal incontinence should take the following actions.
Inform the clinical governance leads in their NHS trusts.
Ensure that patients understand the uncertainty about the procedure's efficacy (especially in the long term) and the risk of complications that may need removal of the band. They should inform them fully about other treatment options and about the value of research studies (when appropriate), and provide them with clear written information. In addition, the use of NICE's Information for the public is recommended.
1.3 Clinicians should offer all eligible patients entry into the HTA trial – 12/35/07. Data about all patients who do not enter the trial should be collected for local audit and review with a view to collaborative publication of outcomes.
1.4 The procedure should only be performed in units specialising in the assessment and treatment of faecal incontinence.
1.5 NICE will review the procedure when the results of the HTA trial are available. Research outcomes for any future studies should include disease-related quality of life.