Abstract
PurposeFaecal 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.Method and designThe 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 18months 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.DiscussionSaFaRI 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.
Highlights
Faecal incontinence (FI) is a common and distressing condition with an estimated prevalence of 7.7 % for the adult population [1]
Treatment strategies for adult FI are summarised in the National Institute for Health and Care Excellence (NICE) 2007 guidance, which supports the use of sacral nerve stimulation (SNS) for the treatment of adult FI refractory to conservative measures [3]
The SaFaRI trial will involve a thorough evaluation of the FENIXTM magnetic sphincter augmentation (MSA) device, as compared to SNS, for the treatment of adult FI
Summary
Faecal incontinence (FI) is a common and distressing condition with an estimated prevalence of 7.7 % (range 2.0–20.7 %) for the adult population [1]. SNS works by electrical stimulation of the sacral (S2–S4) nerve roots, producing a combination of anal sphincter augmentation and modulation of spinal/supraspinal pathways It benefits from a two-stage procedure, which enables the patient to assess acceptability and the clinician to evaluate efficacy prior to permanent implantation. The aim of the trial is to undertake a randomised comparison of the FENIXTM MSA as compared to SNS in terms of safety, efficacy, quality of life and cost-effectiveness. The results are expected to provide rigorous data on FENIXTM MSA, SNS and a “no treatment” group that fail temporary SNS and are treated by alternative means for the duration of trial recruitment
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