Varma Sanskriti, Scott Luisa L, Sibelli Alice, Pathipati Mythili, Griser Allen Cameron, Staller Kyle
Division of Gastroenterology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114-2696, USA.
Division of Gastroenterology, Center for Neurointestinal Health, Massachusetts General Hospital, Boston, MA, USA.
Dig Dis Sci. 2025 Apr;70(4):1441-1448. doi: 10.1007/s10620-025-08871-w. Epub 2025 Feb 14.
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.
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.
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.
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.
高达20%的肠易激综合征（IBS）患者会出现大便失禁（FI），这对生活质量、心理症状和工作能力都有负面影响。我们旨在利用来自用户数据的真实世界证据，评估基于应用程序的肠道定向认知行为疗法（CBT）项目对IBS相关大便失禁（FI）的影响。
研究人群选自2021年8月至2024年2月期间完成了为期3个月的处方CBT项目使用期的1383名Mahana™ IBS用户。患者完成了至少一个为期10节的项目，完成了≥2次症状日志记录，在项目期间报告了≥1次FI发作，并完成了症状严重程度评估（IBS症状严重程度评分系统；IBS-SSS）。混合效应线性回归模型分析了每个疗程中每位用户的FI发作次数，以及IBS-SSS随疗程进展的变化。
66名患者符合纳入标准，平均年龄为49±18岁，基线IBS-SSS为286±标准差104。在第5次和第10次疗程时，IBS-SSS分别降至206±125和193±129（p<0.0001）。每位用户的平均FI发作次数从第1次疗程的5±11次分别降至第5次和第10次疗程的0.5±1.5次和0.1±0.3次（p<0.0001）。反应者分析发现，完成2节及以上疗程的患者中有100%符合首次和最后一次疗程之间FI发作次数减少≥50%的标准。
我们的研究结果表明，肠道定向数字CBT可能会减少IBS相关FI的发生频率。未来的研究应评估脑-肠行为疗法如何影响肛门直肠机械感觉现象。
