{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,7]],"date-time":"2026-05-07T03:09:57Z","timestamp":1778123397730,"version":"3.51.4"},"reference-count":38,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2025,11,11]],"date-time":"2025-11-11T00:00:00Z","timestamp":1762819200000},"content-version":"vor","delay-in-days":10,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000272","name":"National Institute for Health and Care Research","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100016304","name":"Medtronic","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100016304","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Colorectal Disease"],"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>Sacral neuromodulation (SNM) is considered the first\u2010line surgical treatment in adults with refractory faecal incontinence (FI). However, its clinical efficacy has not been rigorously tested in a trial setting.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Method<\/jats:title>\n                    <jats:p>\n                      Randomised, multicentre, double\u2010blind crossover trial (two 16\u2010week periods) of active stimulation versus sham, and open\u2010label follow\u2010up to 58\u2009weeks. Participants: adults aged 18\u201380 with refractory FI. Interventions:\n                      <jats:italic>Active<\/jats:italic>\n                      : subsensory sacral nerve stimulation with an implanted pulse generator;\n                      <jats:italic>Sham<\/jats:italic>\n                      : identical implant but turned off. Primary outcome: FI episodes per week (paper bowel diary) during final 4\u2009weeks of crossover periods (allowing 12\u2009weeks' washout). Randomised allocation (1:1) to arm 1 (SNM\/sham) or arm 2 (sham\/SNM). Blinding: participants, surgeons, assessors; tamper\u2010proof tape\u2010masked stimulation settings. Sample size: 80 patients to detect a 30% reduction in episodes. Groups compared using a paired\n                      <jats:italic>t<\/jats:italic>\n                      \u2010test, and treatment effects summarised by mean differences.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Trial delivery was severely affected by COVID\u201019. Thirty\u2010nine patients of 220 screened (arm 1:\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u200917; arm 2:\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u200922) were recruited at 10 sites (February 2018\u2013July 2022), of whom only 16 (arm 1:\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u20099; arm 2:\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u20097) had complete primary outcome data. Of the 39, 19 completed follow\u2010up to 58\u2009weeks. SNM conferred a non\u2010significant reduction in mean FI episodes per week compared to sham (\u22120.795 [95% CI: \u22121.5 to 0.0],\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.06). Improvements were observed in FI symptoms at 58\u2009weeks compared to baseline (FI episodes per week: 3.2 [SD 3.3] vs. 6.2 [SD 5.9]).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The 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\u2010cost and invasive therapy.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/codi.70308","type":"journal-article","created":{"date-parts":[[2025,11,12]],"date-time":"2025-11-12T05:21:37Z","timestamp":1762924897000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Clinical efficacy of subsensory sacral neuromodulation in adults with faecal incontinence: The\n                    <scp>SUBSoNIC<\/scp>\n                    crossover randomised controlled trial and cohort follow\u2010up study"],"prefix":"10.1111","volume":"27","author":[{"given":"Paul F.","family":"Vollebregt","sequence":"first","affiliation":[{"name":"Centre for Neuroscience, Surgery and Trauma, Faculty of Medicine and Dentistry, Blizard Institute Queen Mary University of London  London UK"},{"name":"Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism Research Institute Amsterdam University Medical Centre  Amsterdam The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yan Li","family":"Goh","sequence":"additional","affiliation":[{"name":"Sandwell and West Birmingham NHS Trust  Birmingham UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anil","family":"Bagul","sequence":"additional","affiliation":[{"name":"University Hospitals Birmingham NHS Foundation Trust  Birmingham UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claire","family":"Chan","sequence":"additional","affiliation":[{"name":"Pragmatic 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"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tom","family":"Dudding","sequence":"additional","affiliation":[{"name":"University Hospital Southampton NHS Foundation Trust  Southampton UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul","family":"Furlong","sequence":"additional","affiliation":[{"name":"Aston Institute of Health and Neurodevelopment, College of Health and Life Sciences Aston University  Birmingham UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shaheen","family":"Hamdy","sequence":"additional","affiliation":[{"name":"Centre for GI Sciences, Division of Diabetes, Endocrinology and Gastroenterology University of Manchester  Manchester UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5728-3636","authenticated-orcid":false,"given":"Joanne","family":"Haviland","sequence":"additional","affiliation":[{"name":"Pragmatic 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"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard","family":"Hooper","sequence":"additional","affiliation":[{"name":"Pragmatic 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"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James","family":"Jones","sequence":"additional","affiliation":[{"name":"Health Sciences Centre, School of Medicine University College Dublin  Dublin Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eleanor","family":"McAlees","sequence":"additional","affiliation":[{"name":"Centre for Neuroscience, Surgery and Trauma, Faculty of Medicine and Dentistry, Blizard Institute Queen Mary University of London  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christine","family":"Norton","sequence":"additional","affiliation":[{"name":"Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care King's College London  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"P. Ronan","family":"O'Connell","sequence":"additional","affiliation":[{"name":"Centre for Colorectal Disease St Vincent's University Hospital  Dublin Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Powar","sequence":"additional","affiliation":[{"name":"Cambridge University Hospitals  Cambridge UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S. Mark","family":"Scott","sequence":"additional","affiliation":[{"name":"Centre for Neuroscience, Surgery and Trauma, Faculty of Medicine and Dentistry, Blizard Institute Queen Mary University of London  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Natasha","family":"Stevens","sequence":"additional","affiliation":[{"name":"Centre for Neuroscience, Surgery and Trauma, Faculty of Medicine and Dentistry, Blizard Institute Queen Mary University of London  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kerry","family":"Tubby","sequence":"additional","affiliation":[{"name":"Centre for Neuroscience, Surgery and Trauma, Faculty of Medicine and Dentistry, Blizard Institute Queen Mary University of London  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sian","family":"Worthen","sequence":"additional","affiliation":[{"name":"Aston Institute of Health and Neurodevelopment, College of Health and Life Sciences Aston University  Birmingham UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuk Lam","family":"Wong","sequence":"additional","affiliation":[{"name":"Pragmatic 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"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charles H.","family":"Knowles","sequence":"additional","affiliation":[{"name":"Centre for Neuroscience, Surgery and Trauma, Faculty of Medicine and Dentistry, Blizard Institute Queen Mary University of London  London UK"},{"name":"Cleveland Clinic London  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,11,11]]},"reference":[{"key":"e_1_2_12_2_1","volume-title":"Incontinence 7th Edition: ICI\u2010ICS","author":"Cardozo L","year":"2023"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1995.03530070057030"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.39231.633275.AD"},{"key":"e_1_2_12_5_1","article-title":"Surgery for faecal incontinence in adults","volume":"2013","author":"Brown SR","year":"2013","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/SLA.0b013e3181cf8ed0"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(04)15999-0"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/bjs.9226"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1097\/SLA.0000000000004251"},{"key":"e_1_2_12_10_1","article-title":"Sacral nerve stimulation for faecal incontinence and constipation in adults","volume":"2015","author":"Thaha MA","year":"2015","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/nmo.14697"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)60314-2"},{"key":"e_1_2_12_13_1","first-page":"351","article-title":"New implantable tibial nerve stimulation devices: review of published clinical results in comparison to established neuromodulation devices","volume":"11","author":"Yamashiro J","year":"2019","journal-title":"Res Rep Urol"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-018-2689-1"},{"key":"e_1_2_12_15_1","unstructured":"https:\/\/www.nice.org.uk\/about\/what\u2010we\u2010do\/our\u2010programmes\/nice\u2010guidance\/nice\u2010interventional\u2010procedures\u2010guidance."},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2005.11.064"},{"key":"e_1_2_12_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/bjs.9695"},{"key":"e_1_2_12_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/ner.12695"},{"key":"e_1_2_12_19_1","doi-asserted-by":"publisher","DOI":"10.1136\/gut.44.1.77"},{"key":"e_1_2_12_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.22559"},{"key":"e_1_2_12_21_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF02237236"},{"key":"e_1_2_12_22_1","doi-asserted-by":"publisher","DOI":"10.1097\/DCR.0b013e3182272128"},{"key":"e_1_2_12_23_1","doi-asserted-by":"publisher","DOI":"10.3109\/07853890109002087"},{"key":"e_1_2_12_24_1","doi-asserted-by":"publisher","DOI":"10.1111\/codi.17075"},{"key":"e_1_2_12_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(17)31327-2"},{"key":"e_1_2_12_26_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10916-016-0537-y"},{"key":"e_1_2_12_27_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF02258292"},{"key":"e_1_2_12_28_1","unstructured":"SorensenMT.Sacral nerve stimulation increases rectal sensitivity in patients with faecal incontinence: results of a randomised double\u2010blinded crossover study. 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