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. 2015 Aug 24;2015(8):CD004464. doi: 10.1002/14651858.CD004464.pub3

Vallance 2014.

Trial name or title Sacral nerve stimulation versus the FENIXTM magnetic anal sphincter for adult faecal incontinence: A randomised investigation (SaFaRI).
Methods Randomised controlled trial, parallel groups
 Blinding: unknown
 Follow‐up: 2 weeks; 6, 12, and 18 months.
Withdrawals: unknown
 Setting: multi‐centre (at least 20 centres), UK
 Intention‐to‐treat analysis: yes
Participants 350
Interventions FENIXTM magnetic anal sphincter (MAS) vs. SNS
Outcomes Primary outcomes: proportion of patients with device in‐situ at 18 months, and proportion of patients reporting > 50% improvement in continence scores.
Secondary outcomes: complications, quality of life, and cost‐effectiveness.
Starting date 01/01/2015
Contact information Primary contact: Professor David Jayne.
Julie Croft: safari@leeds.ac.uk
Notes Funded by NIHR HTA; co‐ordinated by the Clinical Trials Research Unit, University of Leeds.
ISRCTN16077538
DOI 10.1186/ISRCTN16077538
http://www.isrctn.com/ISRCTN16077538