SaFaRI (SNS versus the FENIX MSA for adult FI)
Research type
Research Study
Full title
Sacral nerve stimulation versus the FENIX magnetic sphincter augmentation for adult faecal incontinence: a Randomised Investigation (SaFaRI)
IRAS ID
150031
Contact name
David Jayne
Contact email
Sponsor organisation
Leeds Teaching Hospital NHS Trust
Research summary
Faecal incontinence (FI) affects between 5% and 10% of the adult population. It is more common in females and with advancing age, and is the second most common cause of admission to a nursing home. It impacts on social, physical, and mental well-being and is a substantial and increasing burden on NHS health resources.
Sacral nerve stimulation (SNS) is recognised by NICE as an effective treatment for FI that is resistant to simple measures. It involves the placement of a fine electrode through the skin and onto a nerve that supplies the lower bowel. It is performed as a two-stage procedure: a temporary stimulation phase to determine whether the device improves incontinence, and if this is the case, then a permanent SNS device is implanted. Overall, only 50% of patients thought to be eligible for SNS have a functioning device in the long-term due to loss of benefit or irresolvable complications. SNS is expensive with the device costing ~£10,000 and needs regular re-programming and battery replacement requiring further surgery. Recently, a novel Magnetic Sphincter Augmentation (FENIX MSA, Torax Medical Inc, Minnesota, USA) has been introduced for the treatment of FI consisting of a ring of titanium beads with magnetic cores, placed surgically to augment the anal sphincter. The patient pushes as in normal defecation and the force generated separates the beads to allow the stool through the anal canal. Continence is restored by passive attraction of the magnetic beads. Once implanted, the device doesn’t require patient input in order to function. The FENIX MSA costs ~£4,000. Preliminary results are promising with some 70% of patients reporting a benefit. But, studies have been small. To properly evaluate the role of FENIX MSA in the treatment of FI, we will compare it to SNS, which is a NICE recommended treatment for FI.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
14/YH/0128
Date of REC Opinion
25 Jun 2014
REC opinion
Further Information Favourable Opinion