{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,11]],"date-time":"2026-07-11T15:23:50Z","timestamp":1783783430775,"version":"3.55.0"},"reference-count":17,"publisher":"MDPI AG","issue":"21","license":[{"start":{"date-parts":[[2021,10,26]],"date-time":"2021-10-26T00:00:00Z","timestamp":1635206400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>(1) Background: The Sphinkeeper implantation for faecal incontinence (FI) is a novel surgical procedure with limited data on its clinical efficacy. Therefore, we aimed to assess the functional outcome following Sphinkeeper surgery in patients with refractory FI. (2) Methods: Between 2018 and 2020, eleven consecutive patients (9 female) with FI met the inclusion criteria and were enrolled for surgery. Functional outcome and quality of life were evaluated by standard questionnaires pre- and post-surgery. Migration of protheses was demonstrated by 3D endoanal ultrasound. The median follow-up time was eight months (range 3\u201318 months). (3) Results: The median age was 75 years (range 46\u201389 years) with a median BMI of 27.4 (range 21.2\u201330.1). The median number of implanted prostheses per intervention was nine (range 9\u201310). We found no intraoperative or early postoperative complications. After two months, two prostheses in one patient had to be removed due to pain at the perianal skin site. The median St. Mark\u2019s incontinence score decreased significantly from 22 to 13 points (p = 0.008). The SF-12 showed a significant improvement (35.9 versus 46.3) after surgery (p = 0.028). A migration of at least one prosthesis was observed in ten patients (91%). Six (60%) prostheses were found at the same level in another ten patients. (4) Conclusion: Sphinkeeper implantation is a promising surgical technique for patients with severe FI. The complication rate is low, and short-term functional improvement can be achieved even in severe forms of FI. Migration of implants commonly occurs.<\/jats:p>","DOI":"10.3390\/jcm10214965","type":"journal-article","created":{"date-parts":[[2021,10,26]],"date-time":"2021-10-26T23:54:33Z","timestamp":1635292473000},"page":"4965","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Sphinkeeper Procedure for Treating Severe Faecal Incontinence\u2014A Prospective Cohort Study"],"prefix":"10.3390","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1432-2804","authenticated-orcid":false,"given":"Christopher","family":"Dawoud","sequence":"first","affiliation":[{"name":"Department of General Surgery, Division of Visceral Surgery, Medical University Vienna, 1090 Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leonhard","family":"Bender","sequence":"additional","affiliation":[{"name":"Department of General Surgery, Division of Visceral Surgery, Medical University Vienna, 1090 Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kerstin Melanie","family":"Widmann","sequence":"additional","affiliation":[{"name":"Department of General Surgery, Division of Visceral Surgery, Medical University Vienna, 1090 Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6589-5712","authenticated-orcid":false,"given":"Felix","family":"Harpain","sequence":"additional","affiliation":[{"name":"Department of General Surgery, Division of Visceral Surgery, Medical University Vienna, 1090 Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan","family":"Riss","sequence":"additional","affiliation":[{"name":"Department of General Surgery, Division of Visceral Surgery, Medical University Vienna, 1090 Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2021,10,26]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1194","DOI":"10.1097\/DCR.0000000000000514","article-title":"Fecal Incontinence: Community Prevalence and Associated Factors\u2014A Systematic Review","volume":"58","author":"Ng","year":"2015","journal-title":"Dis. Colon Rectum"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"845","DOI":"10.1007\/s00384-008-0489-x","article-title":"Clinical characteristics and quality of life in a cohort of 621 patients with faecal incontinence","volume":"23","author":"Damon","year":"2008","journal-title":"Int. J. Colorectal Dis."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"1589","DOI":"10.1002\/bjs.10298","article-title":"Systematic review of the prevalence of faecal incontinence","volume":"103","author":"Sharma","year":"2016","journal-title":"Br. J. Surg."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"1644","DOI":"10.1002\/bjs.7699","article-title":"Novel bulking agent for faecal incontinence","volume":"98","author":"Ratto","year":"2011","journal-title":"Br. J. Surg."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"608","DOI":"10.1177\/1553350620934932","article-title":"Implantable Agents for Fecal Incontinence: An Age-Matched Retrospective Cohort Analysis of GateKeeper versus SphinKeeper","volume":"27","author":"Grossi","year":"2020","journal-title":"Surg. Innov."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"59","DOI":"10.1007\/s10151-015-1396-0","article-title":"Implantation of SphinKeeper(TM): A new artificial anal sphincter","volume":"20","author":"Ratto","year":"2016","journal-title":"Tech. Coloproctol."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"484","DOI":"10.1002\/bjs.11558","article-title":"Efficacy of Sphinkeeper\u2122 implant in treating faecal incontinence","volume":"107","author":"Litta","year":"2020","journal-title":"Br. J. Surg."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"80","DOI":"10.1111\/codi.14801","article-title":"Sphinkeeper\u2122 for faecal incontinence: A preliminary report","volume":"22","author":"Lisi","year":"2020","journal-title":"Colorectal Dis."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"2161","DOI":"10.1111\/codi.15277","article-title":"Initial experience with SphinKeeper\u2122 intersphincteric implants for faecal incontinence in the UK: A two-centre retrospective clinical audit","volume":"22","author":"Leo","year":"2020","journal-title":"Colorectal Dis."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1136\/gut.44.1.77","article-title":"Prospective comparison of faecal incontinence grading systems","volume":"44","author":"Vaizey","year":"1999","journal-title":"Gut"},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1007\/BF02050307","article-title":"Etiology and management of fecal incontinence","volume":"36","author":"Jorge","year":"1993","journal-title":"Dis. Colon Rectum"},{"key":"ref_12","unstructured":"Rome Foundation (2006). Guidelines\u2014Rome III Diagnostic Criteria for Functional Gastrointestinal Disorders. J. Gastrointest. Liver Dis., 15, 307\u2013312."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"220","DOI":"10.1097\/00005650-199603000-00003","article-title":"A 12-Item Short-Form Health Survey: Construction of scales and preliminary tests of reliability and validity","volume":"34","author":"Ware","year":"1996","journal-title":"Med. Care"},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"156","DOI":"10.1016\/j.ijsu.2019.11.002","article-title":"STROCSS 2019 Guideline: Strengthening the reporting of cohort studies in surgery","volume":"72","author":"Agha","year":"2019","journal-title":"Int. J. Surg."},{"key":"ref_15","first-page":"1453","article-title":"The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: Guidelines for reporting observational studies","volume":"170","author":"Altman","year":"2007","journal-title":"Lancet"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"963","DOI":"10.1007\/s10151-017-1723-8","article-title":"Outcomes of GatekeeperTMprosthesis implantation for the treatment of fecal incontinence: A multicenter observational study","volume":"21","author":"Trenti","year":"2017","journal-title":"Tech. Coloproctol."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"268","DOI":"10.1111\/j.1463-1318.2007.01318.x","article-title":"Pilot study of two new injectable bulking agents for the treatment of faecal incontinence","volume":"10","author":"Maeda","year":"2008","journal-title":"Colorectal Dis."}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/10\/21\/4965\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T07:24:03Z","timestamp":1760167443000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/10\/21\/4965"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,10,26]]},"references-count":17,"journal-issue":{"issue":"21","published-online":{"date-parts":[[2021,11]]}},"alternative-id":["jcm10214965"],"URL":"https:\/\/doi.org\/10.3390\/jcm10214965","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,10,26]]}}}