Jayne 2014.
Trial name or title | SaFaRI: Sacral nerve stimulation versus the FENIX TM magnetic sphincter augmentation for adult faecal incontinence: a randomised Investigation |
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. |