Fecal incontinence (FI) affects 8% of the worldwide population with few effective treatments [1]. Office biofeedback therapy (OBT) is effective in improving symptoms [2]. However, OBT is not widely accessible as it requires highly trained providers, is labor intensive, costly, and requires multiple office visits (6-15/year). There is an unmet need for a digital health-based biofeedback system that provides biofeedback at home or office. We aimed to evaluate the efficacy and safety of a new purposefully-designed system, Bioanatoner, by comparing home (Home BT) with standard biofeedback (OBT) in a randomized controlled trial of FI patients.

Patients with FI (>1 FI episode/wk) were randomized (2:1) to Home BT (5/week) or weekly OBT using high-resolution manometry for 6 weeks. Home BT was performed with Bioanatoner digital therapeutic system consisting of a 3 sensor, flexible, pressure manometry probe that connects via Bluetooth with a smart phone app, providing real time 3-D animation of anorectal muscles (Figure 1). Muscle and sensori-motor coordination training with balloon distensions were performed over 18 minutes using standard protocol. Patients completed daily electronic stool diary and anorectal manometry. Responder = >50% reduction in FI episodes from baseline. Data were compared between the two groups. An a priori sample size calculation was performed using G*Power 3.1. Based on  previous study [2] (α = 0.05 and 80% power), the required sample size was 18 participants.

Of 18 female FI patients, 13 were randomized to Home BT (mean age=64.8 years), and 5 office BT (mean age= 68.0 years). There were 11/13 (84.6%) responders in Home BT and 4/5 (80%) responders in OBT (p=ns). The number of FI episodes/wk (p<0.001), resting (p=0.04) and sustained squeeze (p=0.003) pressures significantly improved after Home BT. The subject global assessment score (SGA) only improved in home group (p=0.006). Patients rated Home BT as easy, convenient and user friendly  and all patients reported that the home biofeedback device was more convenient than office biofeedback. Performing HBT protocol was easy and handling probe was rated as not messy. All patients in OBT (%100) and 90% of those in home BT indicated that they would recommend their BT device to others. There were no treatment or device-related adverse events.

Home BT was as efficacious as OBT in improving symptoms and anorectal physiology in FI patients.  Patients rated Bioanatoner as useful and user-friendly for delivering BT.  Device was highly acceptable and well tolerated for home-use. Bioanatoner is the first purposefully-designed, manometric Home BT system with a self-guided protocol that demonstrates equivalent efficacy to OBT in improving bowel symptoms.

The novel hybrid digital therapeutic Bioanatoner system was efficacious and well tolerated for BT. It can be used in-office or at-home and thereby significantly enhances access to BT. Bioanatoner provides a user-friendly, standardized biofeedback system and protocol for use in FI patients by pelvic health physical therapists and biofeedback therapists.

Mack I, Hahn H, Gödel C, Enck P, Bharucha AE. Global Prevalence of Fecal Incontinence in Community-Dwelling Adults: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2024;22(4):712-31.e8.
Xiang X, Sharma A, Patcharatrakul T, Yan Y, Karunaratne T, Parr R, et al. Randomized controlled trial of home biofeedback therapy versus office biofeedback therapy for fecal incontinence. Neurogastroenterol Motil. 2021;33(11):e14168.

Continence 19S (2026) 102643
DOI: 10.1016/j.cont.2026.102643