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
| 1. National Institute for Health Research (NIHR) |
| 2. Health Technology Assessment Programme Grant Ref: 12/35/07) |
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 |