Dig Dis Sci. 2025 Feb 14. doi: 10.1007/s10620-025-08871-w. Online ahead of print.

Sanskriti Varma ^1 2 3, Luisa L Scott ⁴, Alice Sibelli ⁴, Mythili Pathipati ^5 6 7, Allen Cameron Griser ⁴, Kyle Staller ^5 6 7

Author information

¹Division of Gastroenterology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114-2696, USA. sanskriti.varma@gmail.com.

²Division of Gastroenterology, Center for Neurointestinal Health, Massachusetts General Hospital, Boston, MA, USA. sanskriti.varma@gmail.com.

³Harvard Medical School, Boston, MA, USA. sanskriti.varma@gmail.com.

⁴Mahana Therapeutics, 505 Montgomery Street, San Francisco, CA, 94111, USA.

⁵Division of Gastroenterology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114-2696, USA.

⁶Division of Gastroenterology, Center for Neurointestinal Health, Massachusetts General Hospital, Boston, MA, USA.

⁷Harvard Medical School, Boston, MA, USA.

Abstract

Introduction: Fecal incontinence (FI) occurs in up to 20% of irritable bowel syndrome (IBS) patients, with a negative impact on quality of life, psychologic symptoms, and work impairment. We aimed to evaluate the impact of an app-based gut-directed cognitive behavioral therapy (CBT) program on IBS-associated fecal incontinence (FI) using real-world evidence from user data.

Methods: The study population was selected from 1,383 Mahana™ IBS users who had completed a 3-month access period for a prescription CBT program between August 2021 and February 2024. Patients completed at least one of the 10-session program, completed ≥ 2 symptom log entries, reported ≥ 1 FI episode during the program, and completed assessments of symptom severity (IBS Symptom Severity Scoring System; IBS-SSS). Mixed-effects linear regression models analyzed the number of FI episodes/user during each session and changes in IBS-SSS as a function of session progression.

Results: Sixty-six patients met inclusion criteria with mean age of 49 ± 18 years and a baseline IBS-SSS of 286 ± SD 104. IBS-SSS decreased to 206 ± 125 and 193 ± 129 at sessions 5 and 10, respectively (p < 0.0001). Mean FI episodes/user decreased from 5 ± 11 in session 1 to 0.5 ± 1.5 and 0.1 ± 0.3 in sessions 5 and 10, respectively (p < 0.0001). Responder analysis found that 100% of patients who completed 2 + sessions met the criteria of ≥ 50% reduction in FI episodes between their first and last session.

Discussion: Our findings suggest that gut-directed digital CBT may reduce the frequency of IBS-associated FI. Future studies should evaluate how brain-gut behavioral therapies can affect anorectal mechanosensory phenomena.