Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ASCO Annual Meeting 2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

2024 ASCO Annual Meeting

Keep up to date with all the top stories and latest evidence with our hub page, including official congress videos and expert takeaways.
ADVANCED SEARCH
Log in
Top
International Journal of Colorectal Disease
Published in: International Journal of Colorectal Disease 2/2016

Open Access 01-02-2016 | Clinical Study Protocol

SaFaRI: sacral nerve stimulation versus the FENIX™ magnetic sphincter augmentation for adult faecal incontinence: a randomised investigation

Authors: Annabelle E. Williams, Julie Croft, Vicky Napp, Neil Corrigan, Julia M. Brown, Claire Hulme, Steven R. Brown, Jen Lodge, David Protheroe, David G. Jayne

Published in: International Journal of Colorectal Disease | Issue 2/2016

Login to get access

Abstract

Purpose

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.

Method and design

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 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.

Discussion

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.
Literature
1.
Ng KS, Sivakumaran Y, Nassar N, Gladman MA (2015) Fecal Incontinence: community prevalence and associated factors—a systematic review. Dis Colon Rectum 58:1194–1209CrossRefPubMed
2.
Dudding TC, Meng Lee E, Faiz O, Pares D, Vaizey CJ, McGuire A, Kamm MA (2008) Economic evaluations of sacral nerve stimulation or faecal incontinence. Br J Surg 95:1153–1163CrossRef
3.
National Institute for Health and Clinical Excellence (2007) The management of faecal incontinence in adults. Clinical Guideline CG49, London
4.
Matzel KE, Stadelmaier U, Hohenfellner M, Gall FP (1995) Electrical stimulation of sacral spinal nerves for treatment of faecal incontinence. Lancet 346:1124–1127CrossRefPubMed
5.
Elenhorst J, Koch SM, Uludag O, van Gemert WG, Baeten CG (2007) Sacral neuromodulation in patients with faecal incontinence: results of the first 100 permanent implantations. Color Dis 9:725–730CrossRef
6.
Tjandra JUJ, Lim JF, Matzel K (2004) Sacral nerve stimulation: an emerging treatment for faecal incontinence. ANZ J Surg 74:1098–1106CrossRefPubMed
7.
Altomare DF, Ratto C, Ganio E, Lolli P, Main A, Villani RD (2009) Long-term outcome of sacral nerve stimulation for fecal incontinence. Dis Colon Rectum 52:11–17CrossRefPubMed
8.
Thin NN, Horrocks EJ, Hotouras A, Palit S, Thaha MA, Chan CL, Matzel KE, Knowles CH (2013) Systematic review of the clinical effectiveness of neuromodulation in the treatment of faecal incontinence. Br J Surg 100:1430–1447CrossRefPubMed
9.
Hetzer FH, Bieler A, Hahnloser D, Lohlein F, Clavien PA, Demartines N (2006) Outcome and cost analysis of sacral nerve stimulation for faecal incontinence. Br J Surg 93:1411–1417CrossRefPubMed
10.
Barussaud ML, Mantoo S, Wyart V, Meurette G, Lehur PA (2013) The magnetic anal sphincter in faecal incontinence: is initial success sustained over time? Color Dis 15:1499–1503CrossRef
11.
Pakravan F, Helmes C (2015) Magnetic anal sphincter augmentation in patients with severe fecal incontinence. Dis Colon Rectum 58:109–114CrossRefPubMed
12.
Lehur PA, McNevin S, Buntzen S, Mellgren AF, Laurberg S, Madoff RD (2010) Magnetic anal sphincter augmentation for the treatment of fecal incontinence: a preliminary report from a feasibility study. Dis Colon Rectum 53:1604–1610CrossRefPubMed
13.
Wong MT, Meurette G, Stangherlin P, Lehur PA (2011) The magnetic anal sphincter versus the artificial bowel sphincter: a comparison of 2 treatments for fecal incontinence. Dis Colon Rectum 54:773–779CrossRefPubMed
14.
15.
Jorge J, Wexner S (1993) Etiology and management of fecal incontinence. Dis Colon Rectum 36:77–97CrossRefPubMed
16.
Renzi A, Brillantino A, Di Sarno G, d’Aniello F (2013) Five-item score for obstructed defecation syndrome: study of validation. Surg Innov 20:119–125CrossRefPubMed
17.
Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC (2000) Fecal Incontinence quality of life scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum 43:9–16CrossRefPubMed
18.
The EuroQol Group (1990) EuroQol—a new facility for the measurement of health-related quality of life. Health Policy 16:199–208CrossRef
19.
Ware J Jr, Kosinski M, Keller SD (1996) A 12-item short-form health survey: construction of scales and preliminary tests of reliability and validity. Med Care 34:220–233CrossRefPubMed
20.
Brooks RG, Jendteg S, Lindgren B, Persson U, Björk S (1991) EuroQoL: health-related quality of life measurement. Results of the Swedish questionnaire exercise. Health Policy 18:37–48CrossRefPubMed
21.
Kind P, Dolan P (1995) The effect of past and present illness experience on the valuations of health states. Med Care 33(4 Suppl):AS255–AS263PubMed
22.
Manca A, Hawkins N, Sculpher MJ (2006) Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. Health Econ 14:487–496CrossRef
23.
Brazier JE, Roberts J, Deverill M (2002) The estimation of a preference based measure of health from the SF-36. J Health Econ 21:271–292CrossRefPubMed
24.
National Institute of Health and Clinical Excellence (2008) Guide to the methods of technology appraisal. National Institute of Health and Clinical Excellence, London
25.
Drummond MF, Sculpher MJ, Torrance GW, O’Brien BJ, Stoddart G (2005) Methods for the economic evaluation of health care programmes, 3rd edn. Oxford University Press, Oxford
26.
27.
Metadata
Title
SaFaRI: sacral nerve stimulation versus the FENIX™ magnetic sphincter augmentation for adult faecal incontinence: a randomised investigation
Authors
Annabelle E. Williams
Julie Croft
Vicky Napp
Neil Corrigan
Julia M. Brown
Claire Hulme
Steven R. Brown
Jen Lodge
David Protheroe
David G. Jayne
Publication date
01-02-2016
Publisher
Springer Berlin Heidelberg
Published in
International Journal of Colorectal Disease / Issue 2/2016
Print ISSN: 0179-1958
Electronic ISSN: 1432-1262
DOI
https://doi.org/10.1007/s00384-015-2492-3

Other articles of this Issue 2/2016

International Journal of Colorectal Disease 2/2016 Go to the issue

Review

Lower GI bleeding: a review of current management, controversies and advances

Original Article

CT imaging for prediction of complications and recurrence in acute uncomplicated diverticulitis

Original Article

Risk factors for surgical site infection following colorectal resection: a multi-institutional study

Original Article

Surgical aspects of inflammatory bowel diseases in pediatric and adolescent age groups

Original Article

Peritumoral adipose tissue as a source of inflammatory and angiogenic factors in colorectal cancer

Original Article

E-PASS score as a useful predictor of postoperative complications and mortality after colorectal surgery in elderly patients