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Sacral nerve stimulation versus the magnetic sphincter augmentation device for adult faecal incontinence: the SaFaRI RCT

Sacral nerve stimulation versus the magnetic sphincter augmentation device for adult faecal incontinence: the SaFaRI RCT
Sacral nerve stimulation versus the magnetic sphincter augmentation device for adult faecal incontinence: the SaFaRI RCT

BACKGROUND: Preliminary studies using the FENIX™ (Torax Medical, Minneapolis, MN, USA) magnetic sphincter augmentation device suggest that it is safe to use for the treatment of adult faecal incontinence, but efficacy data are limited.

OBJECTIVE: To compare FENIX with sacral nerve stimulation for the treatment of adult faecal incontinence in terms of safety, efficacy, quality of life and cost-effectiveness.

DESIGN, SETTING AND PARTICIPANTS: Multicentre, parallel-group, unblinded, randomised trial comparing FENIX with sacral nerve stimulation in participants suffering moderate to severe faecal incontinence.

INTERVENTIONS: Participants were randomised on an equal basis to either sacral nerve stimulation or FENIX. Follow-up occurred 2 weeks postoperatively and at 6, 12 and 18 months post randomisation.

MAIN OUTCOME AND MEASURE: The primary outcome was success, defined as device in use and ≥ 50% improvement in Cleveland Clinic Incontinence Score at 18 months post randomisation. Secondary outcomes included complication rates, quality of life and cost-effectiveness. Between 30 October 2014 and 23 March 2017, 99 participants were randomised across 18 NHS sites (50 participants to FENIX vs. 49 participants to sacral nerve stimulation). The median time from randomisation to FENIX implantation was 57.0 days (range 4.0-416.0 days), and the median time from randomisation to permanent sacral nerve stimulation was 371.0 days (range 86.0-918.0 days). A total of 45 out of 50 participants underwent FENIX implantation and 29 out of 49 participants continued to permanent sacral nerve stimulation. The following results are reported, excluding participants for whom the corresponding outcome was not evaluable. Overall, there was success for 10 out of 80 (12.5%) participants, with no statistically significant difference between the two groups [FENIX 6/41 (14.6%) participants vs. sacral nerve stimulation 4/39 (10.3%) participants]. At least one postoperative complication was experienced by 33 out of 45 (73.3%) participants in the FENIX group and 9 out of 40 (22.5%) participants in the sacral nerve stimulation group. A total of 15 out of 50 (30%) participants in the FENIX group ultimately had to have their device explanted. Slightly higher costs and quality-adjusted life-years (incremental = £305.50 and 0.005, respectively) were observed in the FENIX group than in the sacral nerve stimulation group. This was reversed over the lifetime horizon (incremental = -£1306 and -0.23 for costs and quality-adjusted life-years, respectively), when sacral nerve stimulation was the optimal option (net monetary benefit = -£3283), with only a 45% chance of FENIX being cost-effective.

LIMITATIONS: The SaFaRI study was terminated in 2017, having recruited 99 participants of the target sample size of 350 participants. The study is, therefore, substantially underpowered to detect differences between the treatment groups, with significant uncertainty in the cost-effectiveness analysis.

CONCLUSIONS: The SaFaRI study revealed inefficiencies in the treatment pathways for faecal incontinence, particularly for sacral nerve stimulation. The success of both FENIX and sacral nerve stimulation was much lower than previously reported, with high postoperative morbidity in the FENIX group.

FUTURE WORK: Further research is needed to clarify the treatment pathways for sacral nerve stimulation and to determine its true clinical and cost-effectiveness.

TRIAL REGISTRATION: Current Controlled Trials ISRCTN16077538.

FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 18. See the NIHR Journals Library website for further project information.

FAECAL INCONTINENCE, FENIXTM, HEALTH ECONOMICS, RANDOMISED CONTROLLED TRIAL, SACRAL NERVE STIMULATION, SURGERY
1366-5278
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Jayne, David G
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Williams, Annabelle E
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Corrigan, Neil
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Croft, Julie
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Pullan, Alison
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Napp, Vicky
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Kelly, Rachel
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Meads, David
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Vargas-Palacios, Armando
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Martin, Adam
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Hulme, Claire
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Brown, Steven R
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Nugent, Karen
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Lodge, Jen
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Protheroe, David
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Maslekar, Sushil
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Clarke, Andrew
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Nisar, Pasha
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Brown, Julia M
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Jayne, David G
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Williams, Annabelle E
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Corrigan, Neil
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Croft, Julie
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Napp, Vicky
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Kelly, Rachel
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Meads, David
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Martin, Adam
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Hulme, Claire
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Brown, Steven R
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Nugent, Karen
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Lodge, Jen
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Protheroe, David
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Maslekar, Sushil
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Clarke, Andrew
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Nisar, Pasha
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Brown, Julia M
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Jayne, David G, Williams, Annabelle E, Corrigan, Neil, Croft, Julie, Pullan, Alison, Napp, Vicky, Kelly, Rachel, Meads, David, Vargas-Palacios, Armando, Martin, Adam, Hulme, Claire, Brown, Steven R, Nugent, Karen, Lodge, Jen, Protheroe, David, Maslekar, Sushil, Clarke, Andrew, Nisar, Pasha and Brown, Julia M (2021) Sacral nerve stimulation versus the magnetic sphincter augmentation device for adult faecal incontinence: the SaFaRI RCT. Health technology assessment (Winchester, England), 25 (18), 1-96. (doi:10.3310/hta25180).

Record type: Article

Abstract

BACKGROUND: Preliminary studies using the FENIX™ (Torax Medical, Minneapolis, MN, USA) magnetic sphincter augmentation device suggest that it is safe to use for the treatment of adult faecal incontinence, but efficacy data are limited.

OBJECTIVE: To compare FENIX with sacral nerve stimulation for the treatment of adult faecal incontinence in terms of safety, efficacy, quality of life and cost-effectiveness.

DESIGN, SETTING AND PARTICIPANTS: Multicentre, parallel-group, unblinded, randomised trial comparing FENIX with sacral nerve stimulation in participants suffering moderate to severe faecal incontinence.

INTERVENTIONS: Participants were randomised on an equal basis to either sacral nerve stimulation or FENIX. Follow-up occurred 2 weeks postoperatively and at 6, 12 and 18 months post randomisation.

MAIN OUTCOME AND MEASURE: The primary outcome was success, defined as device in use and ≥ 50% improvement in Cleveland Clinic Incontinence Score at 18 months post randomisation. Secondary outcomes included complication rates, quality of life and cost-effectiveness. Between 30 October 2014 and 23 March 2017, 99 participants were randomised across 18 NHS sites (50 participants to FENIX vs. 49 participants to sacral nerve stimulation). The median time from randomisation to FENIX implantation was 57.0 days (range 4.0-416.0 days), and the median time from randomisation to permanent sacral nerve stimulation was 371.0 days (range 86.0-918.0 days). A total of 45 out of 50 participants underwent FENIX implantation and 29 out of 49 participants continued to permanent sacral nerve stimulation. The following results are reported, excluding participants for whom the corresponding outcome was not evaluable. Overall, there was success for 10 out of 80 (12.5%) participants, with no statistically significant difference between the two groups [FENIX 6/41 (14.6%) participants vs. sacral nerve stimulation 4/39 (10.3%) participants]. At least one postoperative complication was experienced by 33 out of 45 (73.3%) participants in the FENIX group and 9 out of 40 (22.5%) participants in the sacral nerve stimulation group. A total of 15 out of 50 (30%) participants in the FENIX group ultimately had to have their device explanted. Slightly higher costs and quality-adjusted life-years (incremental = £305.50 and 0.005, respectively) were observed in the FENIX group than in the sacral nerve stimulation group. This was reversed over the lifetime horizon (incremental = -£1306 and -0.23 for costs and quality-adjusted life-years, respectively), when sacral nerve stimulation was the optimal option (net monetary benefit = -£3283), with only a 45% chance of FENIX being cost-effective.

LIMITATIONS: The SaFaRI study was terminated in 2017, having recruited 99 participants of the target sample size of 350 participants. The study is, therefore, substantially underpowered to detect differences between the treatment groups, with significant uncertainty in the cost-effectiveness analysis.

CONCLUSIONS: The SaFaRI study revealed inefficiencies in the treatment pathways for faecal incontinence, particularly for sacral nerve stimulation. The success of both FENIX and sacral nerve stimulation was much lower than previously reported, with high postoperative morbidity in the FENIX group.

FUTURE WORK: Further research is needed to clarify the treatment pathways for sacral nerve stimulation and to determine its true clinical and cost-effectiveness.

TRIAL REGISTRATION: Current Controlled Trials ISRCTN16077538.

FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 18. See the NIHR Journals Library website for further project information.

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Published date: 1 March 2021
Additional Information: Funding Information: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 18. See the NIHR Journals Library website for further project information. We are indebted to the patients who participated in this trial. We would also like to thank the TSC (Charles Knowles, Doreen McClurg, Graeme MacLennan and Tara Willson), the DMEC (Paul-Antoine LeHur, Natalie Rowland and Lynn Shaw), additional members of the Trial Management Group (Gregory Taylor, Sushil Maslekar, David Meads, Armando Vargas-Palacios, Alison Smith, Debbie Beirne, Adam Douglas, Jacqueline Emkes, Catherine Moriarty, David Protheroe, Jen Lodge and Karen Nugent) and the CTRU Project Team for their important contributions. Sarah Abraham provided assistance during the economic evaluation. Funding Information: Declared competing interests of authors: David G Jayne reports grants from National Institute for Health Research (NIHR) Senior Investigator awards, and that he was a member of the NIHR Efficacy and Mechanism Evaluation (EME) Strategy Group and Prioritisation Group (2015–18) and NIHR Clinical Scientist Awards Panel (2015–2018). He currently sits on the NIHR Advanced Fellowship Panel (2018 to present) and is a member of the NIHR i4i Product Development Awards Committee (2019 to present). Julia M Brown reports grants from NIHR Senior Investigator awards and the NIHR Funding Committee during the conduct of the study, and declares membership of the Health Technology Assessment (HTA) Remit and Competitiveness Group (2016 to present), Clinical Trial Units funded by NIHR, the HTA Funding Committee Policy Group (2016 to present) and the HTA Clinical Evaluation and Trials Committee (2016 to present). Claire Hulme was a member of the NIHR HTA Commissioning Board (2013–17). Steven Brown was a member of the HTA Commissioning Board (2018–19). David Meads was a member of the NIHR HTA Elective and Emergency Specialist Care (EESC) Methods Group (2014–17) and NIHR HTA EESC Panel (2013–17). He is a member of a NIHR Programme Grants for Applied Research subpanel (2017 to present). Funding Information: Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 18. See the NIHR Journals Library website for further project information. Funding Information: The research reported in this issue of the journal was funded by the HTA programme as project number 12/35/07. The contractual start date was in January 2014. The draft report began editorial review in June 2019 and was accepted for publication in October 2020. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report. Funding Information: This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health and Social Care. Publisher Copyright: © Queen’s Printer and Controller of HMSO 2021.
Keywords: FAECAL INCONTINENCE, FENIXTM, HEALTH ECONOMICS, RANDOMISED CONTROLLED TRIAL, SACRAL NERVE STIMULATION, SURGERY

Identifiers

Local EPrints ID: 448649
URI: http://eprints.soton.ac.uk/id/eprint/448649
ISSN: 1366-5278
PURE UUID: 2854ceea-9af0-4c13-a04f-ce4c658407a3

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Date deposited: 29 Apr 2021 16:30
Last modified: 16 Mar 2024 11:54

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Contributors

Author: David G Jayne
Author: Annabelle E Williams
Author: Neil Corrigan
Author: Julie Croft
Author: Alison Pullan
Author: Vicky Napp
Author: Rachel Kelly
Author: David Meads
Author: Armando Vargas-Palacios
Author: Adam Martin
Author: Claire Hulme
Author: Steven R Brown
Author: Karen Nugent
Author: Jen Lodge
Author: David Protheroe
Author: Sushil Maslekar
Author: Andrew Clarke
Author: Pasha Nisar
Author: Julia M Brown

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