Evidence map›Paper›PMID 41220094›Full record

Trial reportColorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland2025

Clinical efficacy of subsensory sacral neuromodulation in adults with faecal incontinence: The SUBSoNIC crossover randomised controlled trial and cohort follow-up study.

Paul F Vollebregt, Yan Li Goh, Anil Bagul, Claire Chan, Tom Dudding, Paul Furlong, Shaheen Hamdy, Joanne Haviland, Richard Hooper, James Jones and 10 more

Abstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Clinical efficacy of subsensory sacral neuromodulation in adults with faecal incontinence: The SUBSoNIC crossover randomised controlled trial and cohort follow-up study.Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2025
    Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Paul F VollebregtCentre for Neuroscience, Surgery and Trauma, Faculty of Medicine and Dentistry, Blizard Institute, Queen Mary University of London, London, UK.
Yan Li GohSandwell and West Birmingham NHS Trust, Birmingham, UK.
Anil BagulUniversity Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
Claire ChanPragmatic Clinical Trials Unit, Centre for Evaluation and Methods, Faculty of Medicine and Dentistry, Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
Tom DuddingUniversity Hospital Southampton NHS Foundation Trust, Southampton, UK.
Paul FurlongAston Institute of Health and Neurodevelopment, College of Health and Life Sciences, Aston University, Birmingham, UK.
Shaheen HamdyCentre for GI Sciences, Division of Diabetes, Endocrinology and Gastroenterology, University of Manchester, Manchester, UK.
Joanne HavilandPragmatic Clinical Trials Unit, Centre for Evaluation and Methods, Faculty of Medicine and Dentistry, Wolfson Institute of Population Health, Queen Mary University of London, London, UK.ORCID https://orcid.org/0000-0001-5728-3636
Richard HooperPragmatic Clinical Trials Unit, Centre for Evaluation and Methods, Faculty of Medicine and Dentistry, Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
James JonesHealth Sciences Centre, School of Medicine, University College Dublin, Dublin, Ireland.
Eleanor McAleesCentre for Neuroscience, Surgery and Trauma, Faculty of Medicine and Dentistry, Blizard Institute, Queen Mary University of London, London, UK.
Christine NortonFlorence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK.
P Ronan O'ConnellCentre for Colorectal Disease, St Vincent's University Hospital, Dublin, Ireland.
Michael PowarCambridge University Hospitals, Cambridge, UK.
S Mark ScottCentre for Neuroscience, Surgery and Trauma, Faculty of Medicine and Dentistry, Blizard Institute, Queen Mary University of London, London, UK.
Natasha StevensCentre for Neuroscience, Surgery and Trauma, Faculty of Medicine and Dentistry, Blizard Institute, Queen Mary University of London, London, UK.
Kerry TubbyCentre for Neuroscience, Surgery and Trauma, Faculty of Medicine and Dentistry, Blizard Institute, Queen Mary University of London, London, UK.
Sian WorthenAston Institute of Health and Neurodevelopment, College of Health and Life Sciences, Aston University, Birmingham, UK.
Yuk Lam WongPragmatic Clinical Trials Unit, Centre for Evaluation and Methods, Faculty of Medicine and Dentistry, Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
Charles H KnowlesCentre for Neuroscience, Surgery and Trauma, Faculty of Medicine and Dentistry, Blizard Institute, Queen Mary University of London, London, UK.

Funding

MedtronicNational Institute for Health and Care Research
6 · The paper itself

Abstract

aimSacral neuromodulation (SNM) is considered the first-line surgical treatment in adults with refractory faecal incontinence (FI). However, its clinical efficacy has not been rigorously tested in a trial setting.

methodRandomised, multicentre, double-blind crossover trial (two 16-week periods) of active stimulation versus sham, and open-label follow-up to 58 weeks.

participantsadults aged 18-80 with refractory FI.

interventionsActive: subsensory sacral nerve stimulation with an implanted pulse generator; Sham: identical implant but turned off. PRIMARY OUTCOME: FI episodes per week (paper bowel diary) during final 4 weeks of crossover periods (allowing 12 weeks' washout). Randomised allocation (1:1) to arm 1 (SNM/sham) or arm 2 (sham/SNM). BLINDING: participants, surgeons, assessors; tamper-proof tape-masked stimulation settings. SAMPLE SIZE: 80 patients to detect a 30% reduction in episodes. Groups compared using a paired t-test, and treatment effects summarised by mean differences.

resultsTrial delivery was severely affected by COVID-19. Thirty-nine patients of 220 screened (arm 1: N = 17; arm 2: N = 22) were recruited at 10 sites (February 2018-July 2022), of whom only 16 (arm 1: N = 9; arm 2: N = 7) had complete primary outcome data. Of the 39, 19 completed follow-up to 58 weeks. SNM conferred a non-significant reduction in mean FI episodes per week compared to sham (-0.795 [95% CI: -1.5 to 0.0], p = 0.06). Improvements were observed in FI symptoms at 58 weeks compared to baseline (FI episodes per week: 3.2 [SD 3.3] vs. 6.2 [SD 5.9]).

conclusionsThe SUBSoNIC trial failed to find conclusive evidence of the experimental efficacy of SNM. Further demonstration of experimental efficacy remains important as SNM is a high-cost and invasive therapy.

Indexed as

Electric Stimulation TherapyFecal IncontinenceLumbosacral PlexusAdolescentAdultAgedAged, 80 and overCross-Over StudiesDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMiddle AgedTreatment OutcomeYoung Adultanal incontinencefaecal incontinenceneuromodulationsacral nerve stimulation

Identifiers

PMID41220094
PMCPMC12605715

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.