title: SaFaRI: sacral nerve stimulation versus the FENIX magnetic sphincter augmentation for adult faecal incontinence: a randomised investigation.
abstract: OBJECTIVE
  Faecal incontinence is a physically, psychologically and socially disabling condition. NICE guidance (2007) recommends surgical intervention, including sacral nerve stimulation (SNS), after failed conservative therapies. The FENIX magnetic sphincter augmentation (MSA) device is a novel continence device consisting of a flexible band of interlinked titanium beads with magnetic cores that is placed around the anal canal to augment anal sphincter tone through passive attraction of the beads. Preliminary studies suggest the FENIX MSA is safe, but efficacy data is limited. Rigorous evaluation is required prior to widespread adoption.
  
  
  METHODS
  The SaFaRI trial is a National Institute of Health Research (NIHR) Health Technology Assessment (HTA)-funded UK multi-site, parallel group, randomised controlled, unblinded trial that will investigate the use of the FENIX MSA, as compared to SNS, for adult faecal incontinence resistant to conservative management. Twenty sites across the UK, experienced in the treatment of faecal incontinence, will recruit 350 patients randomised equally to receive either SNS or FENIX MSA. Participants will be followed-up at 2 weeks post-surgery and at 6, 12 and 18 months post-randomisation. The primary endpoint is success, as defined by device in use and ≥50 % improvement in the Cleveland Clinic Incontinence Score (CCIS) at 18 months post-randomisation. Secondary endpoints include complications, quality of life and cost effectiveness.
  
  
  CONCLUSIONS
  SaFaRI will rigorously evaluate a new technology for faecal incontinence, the FENIX™ MSA, allowing its safe and controlled introduction into current clinical practice. These results will inform the future surgical management of adult faecal incontinence.
authors.affiliation: Leeds Institute of Biological and Clinical Sciences, St. James's University Hospital, Level 7 Clinical Sciences Building, Leeds, LS9 7TF, UK. a.e.williams@leeds.ac.uk.
authors.forename: Annabelle E
authors.identifier: http://orcid.org/0000-0001-8832-6686
authors.initials: AE
authors.lastname: Williams
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK. j.croft@leeds.ac.uk.
authors.forename: Julie
authors.initials: J
authors.lastname: Croft
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK. v.napp@leeds.ac.uk.
authors.forename: Vicky
authors.initials: V
authors.lastname: Napp
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK. n.corrigan@leeds.ac.uk.
authors.forename: Neil
authors.initials: N
authors.lastname: Corrigan
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK. j.m.b.brown@leeds.ac.uk.
authors.forename: Julia M
authors.initials: JM
authors.lastname: Brown
authors.affiliation: Leeds Institute of Health Sciences, University of Leeds, Charles Thackray Building, 101 Clarendon Road,, Leeds, LS2 9LJ, UK. c.t.hulme@leeds.ac.uk.
authors.forename: Claire
authors.initials: C
authors.lastname: Hulme
authors.affiliation: Dept. of Colorectal Surgery, University of Sheffield, Northern General Hospital, Sheffield, South Yorkshire, S5 7 AU, UK. steven.brown@sth.nhs.uk.
authors.forename: Steven R
authors.initials: SR
authors.lastname: Brown
authors.affiliation: Leeds Primary Healthcare NHS Trust, St Mary's Hospital, Leeds, LS12 3QE, UK. jen.lodge@nhs.net.
authors.forename: Jen
authors.initials: J
authors.lastname: Lodge
authors.affiliation: Leeds and York Partnership NHS Foundation Trust, Department of Liaison Psychiatry, Leeds General Infirmary, Great George Street, Leeds, West Yorkshire, LS1 3EX, UK. david.protheroe@nhs.net.
authors.forename: David
authors.initials: D
authors.lastname: Protheroe
authors.affiliation: Leeds Institute of Biological and Clinical Sciences, St. James's University Hospital, Level 7 Clinical Sciences Building, Leeds, LS9 7TF, UK. d.g.jayne@leeds.ac.uk.
authors.forename: David G
authors.initials: DG
authors.lastname: Jayne
mesh_terms: D000328:Adult; D001003:Anal Canal; D003362:Cost-Benefit Analysis; D004599:Electric Stimulation Therapy / Q000009:adverse effects / Q000191:economics / Q000379:methods*; D005242:Fecal Incontinence / Q000628:therapy*; D006801:Humans; D055909:Magnetic Field Therapy / Q000009:adverse effects / Q000191:economics / Q000379:methods*; D011446:Prospective Studies; D011788:Quality of Life; D012447:Sacrum / Q000294:innervation*; D013127:Spinal Nerves
keywords: FENIXTM; Faecal incontinence; Randomised controlled trial; Sacral nerve stimulation; Surgery