A Digital Therapeutic Pelvic Health System Improves Fecal Incontinence Symptoms in a Real-World Patient Cohort

Abstract

Background: – Fecal incontinence is a common, yet underdiagnosed condition, disproportionately affecting women and significantly impacting health and quality of life. Pelvic floor muscle training and biofeedback are recommended first-line treatments, yet access, adherence, and stigma remain substantial barriers to care. Digital therapies may offer an effective alternative to address barriers. Objective: – To evaluate real-world outcomes with use of a prescription digital therapeutic device for treatment of fecal incontinence in women. Design: – This observational cohort study analyzed de-identified data from women who used the device between July 1, 2023—August 1, 2024. Settings: – Commercial users of the device in the United States. Patients: – Adult women with fecal incontinence, identified by self-report or clinical diagnosis, who completed baseline and 8-week Colorectal Anal Distress Inventory—CRADI-8 symptom surveys. Intervention(s): – Eight weeks of use of an intravaginal motion-based biofeedback device paired with smartphone application to guide pelvic floor muscle training. Main Outcome Measures: – Baseline-to-8-week Colorectal Anal Distress Inventory—CRADI-8 score change; achievement of Colorectal Anal Distress Inventory—CRADI-8 minimum clinically important difference, global improvement scores, adherence, pelvic floor performance metrics. Results: – Among 214 eligible users, 200 self-reported FI symptoms and 14 had a clinical diagnosis with mean age 58.8 years and mean body mass index 27.5 kg/m 2. Mean CRADI-8 score change was -8.2 points (±15.5; p < 0.0001); 58.4% met the minimum clinically important difference. Of 142 respondents, 73% reported global improvement. Device-captured pelvic floor performance improved significantly. Weekly adherence remained high. No serious device-related adverse events were reported. Limitations: – Selection bias, lack of comparator, reliance on patient reported outcomes, limited clinical diagnostic confirmation, generalizability. Conclusions: – Use of a digital therapeutic device was associated with significant improvements in fecal incontinence and pelvic floor function in a real-world cohort of women. High user engagement and clinically important symptom reduction support the potential of home-based digital interventions to expand access to conservative management and address persistent gaps in women’s pelvic health care. See Video Abstract.