{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T20:42:24Z","timestamp":1777495344778,"version":"3.51.4"},"reference-count":16,"publisher":"American Medical Association (AMA)","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"\n Importance<\/jats:title>\n Fecal incontinence (FI) affects up to 8% of adults and substantially impairs quality of life. Surgical options carry higher risk and cost, and evidence for minimally invasive alternatives, such as anal inserts, is limited.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To determine whether a novel anal insert achieves a clinically meaningful reduction in FI severity compared with usual care.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n This multicenter, open-label, randomized clinical superiority trial was conducted from May 26, 2021, to August 1, 2024, with 8 weeks of treatment and 4 weeks of follow-up at 2 outpatient hospital clinics in the Netherlands. Participants were individuals aged 16 to 90 years with FI (Rome IV criteria) with at least 1 FI episode during a 14-day run-in period. Data were analyzed from August 2 to December 20, 2024.<\/jats:p>\n <\/jats:sec>\n \n Intervention<\/jats:title>\n A single-use anal insert compared with usual care alone.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n The primary outcome was proportion of participants achieving a reduction of at least 3 points in the St Mark\u2019s incontinence score from baseline to 8 weeks. Secondary outcomes included FI-specific quality of life, anxiety, depression, adverse events, and weekly FI episodes (post hoc outcome).<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n A total of 73 participants were screened and 72 were randomized (60 [83.3%] female; mean [SD] age, 67.3 [9.8] years]), with 35 participants receiving the insert and 37 receiving usual care. There was no significant difference in reduction in St Mark\u2019s score (9 participants [25.7%] in the insert group vs 7 participants [18.9%] in the control group; relative risk, 1.36 [95% CI, 0.57 to 3.25]). Coping (mean between-group difference, 0.19 [95% CI, 0.03 to 0.35]) and depression (mean between-group difference, 0.15 [95% CI, 0.01 to 0.30]) domains of the quality-of-life assessment improved more with the insert group, whereas lifestyle and embarrassment domains of the quality-of-life assessment, anxiety, and overall depression showed no between-group differences. The insert reduced FI episodes (estimated mean difference, \u22123.09 [95% CI, \u22124.39 to \u22121.75] episodes per week) and increased the proportion achieving more than 50% reduction in FI episodes. No serious adverse events occurred; device-related adverse events were common but mild.<\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n In this randomized clinical trial, the primary outcome of achieving a reduction of at least 3 points in St Mark\u2019s incontinence score was not met; however, the anal insert improved selected FI-specific quality-of-life domains. These findings suggest that the device may provide a minimally invasive option for selected patients.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT04657588<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2026.9208","type":"journal-article","created":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T15:00:59Z","timestamp":1777388459000},"page":"e269208","source":"Crossref","is-referenced-by-count":0,"title":["Controlling Fecal Incontinence With a Novel Anal Device"],"prefix":"10.1001","volume":"9","author":[{"given":"Sad\u00e9 L.","family":"Assmann","sequence":"first","affiliation":[{"name":"Department of Surgery and Colorectal Surgery, Maastricht University Medical Center, Maastricht, the Netherlands"},{"name":"Department of Gastroenterology-Hepatology, Maastricht University Medical Center, Maastricht, the Netherlands"},{"name":"Institute of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bjorn","family":"Winkens","sequence":"additional","affiliation":[{"name":"Care and Public Health Research Institute, Maastricht University, the Netherlands"},{"name":"Department of Methodology and Statistics, Maastricht University, the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrea","family":"Bours","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology-Hepatology, Maastricht University Medical Center, Maastricht, the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brigitte","family":"Essers","sequence":"additional","affiliation":[{"name":"Care and Public Health Research Institute, Maastricht University, the Netherlands"},{"name":"Department of Clinical Epidemiology and Medical Technology Assessment, Care and Public Health, Maastricht University Medical Center, Maastricht, the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tze","family":"Lam","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology-Hepatology, Rijnstate Hospital, Arnhem, the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zlatan","family":"Mujagi\u0107","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology-Hepatology, Maastricht University Medical Center, Maastricht, the Netherlands"},{"name":"Institute of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"St\u00e9phanie O.","family":"Breukink","sequence":"additional","affiliation":[{"name":"Department of Surgery and Colorectal Surgery, Maastricht University Medical Center, Maastricht, the Netherlands"},{"name":"Institute of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, the 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