{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T09:51:12Z","timestamp":1792835472717,"version":"4.5.0"},"reference-count":40,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T00:00:00Z","timestamp":1784592000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T00:00:00Z","timestamp":1784592000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2026,9]]},"abstract":"ABSTRACT<\/jats:title>\n \n Background<\/jats:title>\n \n Treatment options for medically\u2010refractory faecal incontinence (\n FI<\/jats:styled-content>\n )\u2014including anorectal biofeedback, dextranomer injection, and sacral nerve stimulation\u2014are limited and outcomes are often suboptimal. Anal or vaginal insert devices are infrequently used.\n <\/jats:p>\n <\/jats:sec>\n \n Aims<\/jats:title>\n We evaluated the safety and effectiveness of a new anal insert device (StaySure) in patients with FI.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n Patients with FI for\u2009\u2265\u20096\u2009months and\u2009\u2265\u20094 moderate or large FI episodes during a 4\u2010week baseline entered a 2\u20134\u2009week fitting\/run\u2010in period to individualise device size (10 or 13\u2009mm) followed by a 4\u2010week treatment period. Outcomes included effectiveness, safety, and quality of life (QoL). The primary outcome was the proportion achieving a\u2009\u2265\u200950% reduction in FI frequency.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Of 124 enrolled patients, 98, 71, and 61 progressed through the baseline, fitting\/run\u2010in, and treatment phases respectively, with few exclusions due to device intolerance. In the intent\u2010to\u2010treat cohort of 59 participants (93% women), mean (\n SD<\/jats:styled-content>\n ) number of days with\n FI<\/jats:styled-content>\n declined from 13.2 (7.0) to 6.3 (6.9), and\n FI<\/jats:styled-content>\n weekly episodes declined from 5.4 (6.9) to 2.1 (5.1) (69% reduction;\n p\u2009<<\/jats:italic>\n \u20090.001) with similar results for both device sizes. The primary endpoint was achieved in 76.3% of participants; 54.2% achieved\u2009\u2265\u200975% reduction. The\n FIQoL<\/jats:styled-content>\n overall score increased from a mean (\n SD<\/jats:styled-content>\n ) of 1.9 (0.6) to 2.3 (0.6) (\n p<\/jats:italic>\n \u2009<\u20090.001), indicating improved\n QoL<\/jats:styled-content>\n . Improvements in\n FI<\/jats:styled-content>\n frequency,\n FIQoL<\/jats:styled-content>\n exceeded minimal clinically important difference thresholds, confirming clear clinical benefit. No treatment\u2010related serious adverse events were reported.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n The StaySure anal insert device is safe, well tolerated, and effective in reducing FI in patients with moderate to severe symptoms refractory to conservative therapies.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov<\/jats:ext-link>\n identifier: NCT03898778\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/apt.70831","type":"journal-article","created":{"date-parts":[[2026,7,22]],"date-time":"2026-07-22T06:47:20Z","timestamp":1784702840000},"page":"603-614","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Clinical Trial: Effectiveness and Safety of a Novel Anal Insert Device for Treatment of Faecal Incontinence"],"prefix":"10.1111","volume":"64","author":[{"given":"Adil E.","family":"Bharucha","sequence":"first","affiliation":[{"name":"Division of Gastroenterology and Hepatology (Bharucha, Oblizajek, and Szarka), Department of Radiology (Fletcher), and Division of Clinical Trials and Biostatistics (Bailey) Mayo Clinic, Mayo Clinic School of Graduate Medical Education, Mayo Clinic College of Medicine and Science Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramesh","family":"Lamichhane","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology (Bharucha, Oblizajek, and Szarka), Department of Radiology (Fletcher), and Division of Clinical Trials and Biostatistics (Bailey) Mayo Clinic, Mayo Clinic School of Graduate Medical Education, Mayo Clinic College of Medicine and Science Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joel G.","family":"Fletcher","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology (Bharucha, Oblizajek, and Szarka), Department of Radiology (Fletcher), and Division of Clinical Trials and Biostatistics (Bailey) Mayo Clinic, Mayo Clinic School of Graduate Medical Education, Mayo Clinic College of Medicine and Science Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6444-3386","authenticated-orcid":false,"given":"Nicholas R.","family":"Oblizajek","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology (Bharucha, Oblizajek, and Szarka), Department of Radiology (Fletcher), and Division of Clinical Trials and Biostatistics (Bailey) Mayo Clinic, Mayo Clinic School of Graduate Medical Education, Mayo Clinic College of Medicine and Science Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3826-2132","authenticated-orcid":false,"given":"Misha","family":"Gautam","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology (Bharucha, Oblizajek, and Szarka), Department of Radiology (Fletcher), and Division of Clinical Trials and Biostatistics (Bailey) Mayo Clinic, Mayo Clinic School of Graduate Medical Education, Mayo Clinic College of Medicine and Science Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kent R.","family":"Bailey","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology (Bharucha, Oblizajek, and Szarka), Department of Radiology (Fletcher), and Division of Clinical Trials and Biostatistics (Bailey) Mayo Clinic, Mayo Clinic School of Graduate Medical Education, Mayo Clinic College of Medicine and Science Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence A.","family":"Szarka","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology (Bharucha, Oblizajek, and Szarka), Department of Radiology (Fletcher), and Division of Clinical Trials and Biostatistics (Bailey) Mayo Clinic, Mayo Clinic School of Graduate Medical Education, Mayo Clinic College of Medicine and Science Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,21]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2023.09.004"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2006.01.003"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41572-022-00381-7"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2010.07.056"},{"key":"e_1_2_10_6_1","article-title":"Cluster Analysis of Fecal Incontinence Symptoms: Associations With Anorectal Physiology and Quality of Life","author":"Butt M. 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