Interventional procedure consultation document

Insertion of a magnetic bead band for faecal incontinence

Faecal incontinence is an inability to control bowel movements, resulting in the involuntary passage of stools. Insertion of a magnetic bead band involves placing a ring of magnetic beads around the muscles of the back passage (the anal sphincter) to help keep the sphincter closed.

The National Institute for Health and Care Excellence (NICE) is examining insertion of a magnetic bead band 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 insertion of a magnetic bead band 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·       The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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.

Through its guidance NICE is committed to promoting race and disability equality, 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 interventional procedures guidance. In particular, we aim to encourage people and organisations from groups who might not normally comment on our guidance to do so.

In order to help us promote equality through our guidance, we should be grateful if you would 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, advance equality of opportunity, and foster good relations between people with a characteristic protected by the equalities legislation and others?

Please note that NICE reserves the right to summarise and edit comments received during consultations or not to publish them at all where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 19 December 2013

Target date for publication of guidance: 26 March 2014

 

1                      Provisional recommendations

 

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 [[URL to be added at publication]] 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.

 

2                      Indications and current treatments

 

2.1                  Faecal incontinence is an inability to control bowel movements, resulting in the involuntary passage of stools. Causes include problems in the rectum, problems with the sphincter muscles (such as damage caused by childbirth), or nerve damage (such as multiple sclerosis, stroke or spina bifida). Faecal incontinence can also occur in conditions such as dementia or severe learning disability.

2.2                  Initial management of faecal incontinence includes interventions related to diet, bowel habit and toilet access, and medication (see Faecal incontinence: the management of faecal incontinence in adults [NICE clinical guideline 49]). Specialised management options depend on the underlying cause and include pelvic floor muscle training, bowel retraining, specialist dietary assessment and management, biofeedback, electrical stimulation and rectal irrigation. The main surgical treatment is anal sphincter repair. Sacral nerve stimulation is sometimes used for people with faecal incontinence in whom sphincter surgery is deemed inappropriate. If a trial of sacral nerve stimulation is unsuccessful, a neosphincter may be considered (stimulated graciloplasty or an artificial anal sphincter).

 

 

 

3                      The procedure

 

3.1                  Insertion of a magnetic bead band for faecal incontinence aims to reinforce and improve the competence of the anal sphincter to prevent episodes of incontinence without creating obstruction, and with less morbidity than artificial bowel sphincter surgery. The magnetic bead band does not need to be adjusted once it has been inserted.

3.2                  The procedure is done with the patient under general anaesthesia, using stringent asepsis. A tunnel is created around the anal canal via an anterior incision in the perineal body. A sizing tool is inserted to assess the circumference of the anal canal and the size of implant needed. The sizing tool is then removed and the implant is placed circumferentially around the upper anal canal. Fluoroscopy may be used to confirm the correct position. The ends of the implant are tied together. The wound is then closed.

3.3                  The implant consists of a ring of interlinked titanium beads, each with a weak magnetic force that holds the beads together. During defecation, the beads separate, allowing the passage of stool. Magnetic attraction then brings the beads together to re-establish continence.

 

 

4                      Efficacy

 

This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. There was considerable patient overlap between the studies. For more detailed information on the evidence, see the overview.

4.1                  A non-randomised comparative study of 28 patients treated by insertion of a magnetic bead band or sacral nerve stimulation reported improved median continence scores in both groups from 16.5 and 15 at baseline to 6 and 11.5 (p=0.001 and 0.0001) respectively at follow-up (median follow-up 18 and 22 months respectively). A non-randomised comparative study of 20 patients treated by insertion of a magnetic bead band or artificial bowel sphincter reported improved median continence scores in both groups from 17 and 16.5 at baseline to 6 and 5 (p=0.0002 and 0.0001) respectively at follow-up (median follow-up 8 and 22.5 months respectively).

4.2                  The non-randomised comparative study of 28 patients reported statistically significant improvements from baseline in mean quality of life scores at follow-up for all 4 domains (lifestyle, coping/behaviour, depression and embarrassment) in both groups (median follow-up 18 and 22 months respectively). The non-randomised comparative study of 20 patients reported statistically significant improvements in median quality of life scores in both groups from 1.9 and 1.8 at baseline to 3.4 and 3.6 (p=0.005 and 0.009), respectively at follow-up (median follow-up 8 and 22.5 months respectively).

4.3                  A case series of 14 patients reported that 1 patient chose to have the magnetic bead band removed after 69 days because it did not meet her expectations: she opted for a stoma for personal reasons.

4.4                  The specialist advisers stated that the key efficacy outcome is improved continence with accompanying improvement in disease- specific and generic quality of life.

 

5                      Safety

 

This section describes 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.

5.1                  Infection was reported in 14% (2/14) of patients in a case series of 14 patients. One patient developed infection 9 days after the procedure and was treated with systemic antibiotics without success. The implant was removed after 47 days and the patient had a stoma. The other patient had a superficial wound infection 7 days after the procedure that was successfully treated with systemic antibiotics.

5.2                  Swelling and erythema in both gluteal regions 2 weeks after the procedure was reported in 31% (5/16) of patients in a case series of 16 patients: this resolved after conservative treatment.

5.3                  Obstructed defecation was reported in 1 patient in the case series of 14 patients. This resolved within 2 days after treatment with enemas.

5.4                  Rectal bleeding that resolved spontaneously was reported in 1 patient in the case series of 14 patients. Vaginal bleeding that resolved spontaneously was reported in 1 patient in the case series of 16 patients.

5.5                  Pain that resolved after medication was reported in 14% (2/14) of patients in the case series of 14 patients. Pain (not further described) was reported in 31% (5/16) of patients in the case series of 16 patients.

5.6                  Device separation was reported in 1 patient in the case series of 14 patients; the patient reported hearing a ‘crack’ during defecation approximately 1 month after implantation. X-ray showed the device had separated and within a week the patient passed the device without evidence of ulceration on clinical examination.

5.7                  The specialist advisers listed erosion and discomfort as anecdotal adverse events. Theoretical adverse events were chronic pain, device migration, constipation and loss of magnetism.

 

 

6                      Further information

 

6.1                  For related NICE guidance see the NICE website.

 

 

_{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.}

 

         

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

November, 2013