Consort checklist.

<div><p>Biofeedback therapy is useful for treatment of functional defecation disorders but is not widely available and is labor intensive. We developed an Internet-of-Medical-Things (IoMT) device, enabling self-guided biofeedback therapy. This study assesses the safety and efficacy of self-guided biofeedback therapy using the IoMT device in comparison to standard operator-led therapy. Patients experiencing urge or seepage fecal incontinence (≥1 episode/week) were randomly assigned to either our IoMT system or to the conventional anorectal manometry-based therapy. Both interventions comprised six weekly sessions, focusing on enhancing anal strength, endurance, and coordination. The novel device facilitated self-guided therapy via visual instructions on a companion app. Primary outcomes included safety/tolerability, changes in Vaizey severity scores, and alterations in anorectal pressure profiles. Twenty-five patients (22 females, 3 males) participated, with 13 in the novel device group and 12 in the standard therapy group. Both groups showed significant reductions in symptom severity scores: IoMT device group -4.2 (95% CI: -4.06, -4.34, p = 0.018), and the standard therapy group -4.8 (95% CI: -4.31, -5.29, p = 0.028). Anal sphincter resting pressure and sustained squeeze time improved significantly in both groups, and the novel device group demonstrated an increase in maximum sphincter squeeze pressure. There were no significant differences between the therapy groups. Importantly, the experimental device was well-tolerated compared with standard therapy, with no serious adverse events observed. This study demonstrates the comparable efficacy of self-administered biofeedback using the IoMT device with traditional biofeedback therapy. The results demonstrates the potential of the IoMT device as a safe, self-guided method for FI therapy, offering convenience and effectiveness in fecal incontinence management.</p></div>