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

Trial Overview

Acronym	SaFaRI
Number	ISRCTN16077538
Protocol Link	http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0016/123352/PRO-12-35-07.pdf
Public Trial Registry Link	http://www.isrctn.com/ISRCTN16077538
Status	In Follow-Up
Category	Functional
Treatment Course	Surgery

Trial Description

A prospective, UK multi-site, parallel-group, randomised clinical study investigating the safety and efficacy of the FENIXTM magnetic sphincter augmentation (MSA) for adult FI. The comparator is sacral nerve stimulation (SNS), a preferred treatment recommended by the National Institute for Health and Care Excellence (NICE) for the treatment of FI resistant to conservative therapies.

Chief Investigator

David Jayne
Professor

Profile Link

Lead Centre

University of Leeds
.
Leeds
LS2 9JT
UK

Website

Collaboration and Funding

Funding Sponsors

Additional Information

Full Research Summary

Objective:	The study will involve a thorough evaluation of the FENIXTM MSA device, as compared to SNS, for the treatment of adult FI.
Aim:	The objectives of the study are to: i) determine the short-term safety and efficacy of FENIXTM MSA in adult FI. ii) assess FENIXTM MSA and SNS in terms of impact on Quality of Life (QoL) and cost effectiveness.
Methods:	This is a UK multi-site, prospective, parallel-group, randomised controlled, unblinded study to evaluate the safety and efficacy of the FENIXTM MSA for moderate to severe adult FI as compared to SNS, a NICE recommended treatment for FI resistant to conservative therapies. xix 350 participants will be randomised on an equal basis to either FENIXTM MSA or SNS implants. The follow-up period finishes 18 months after the last participant is randomised. The study will not be blinded to participants, medical staff, or clinical trial staff, given the difference between the two devices being compared (SNS treatment requires a temporary implant followed by a permanent implant if successful and involves patient input to function).
Reason for International Trial:	UK only

Trial Details