Original Investigation

Controlling Fecal Incontinence With a Novel Anal Device

JAMA Network Open 10.1001/jamanetworkopen.2026.9208

April 28, 2026 at 11:00 AM EDT

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Can a novel anal insert achieve a clinically meaningful reduction in fecal incontinence (FI) severity compared to care as usual?In this randomized clinical trial that included 73 adults, a significant reduction in FI severity occurred in 25.7% of insert participants and 18.9% of control participants, with no significant difference between groups.This randomized clinical trial found that the novel anal insert was not beneficial on group level.

Corresponding Author: Sadé L. Assmann, MD, Institute of Nutrition and Translational Research in Metabolism, Maastricht Universitair Medisch Centrum+, P Debyelaan 25, Maastricht 6229HX, Netherlands (s.assmann@maastrichtuniversity.nl).

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