Home-based biofeedback with local anal electrical stimulation for fecal incontinence in women without sphincter...

Fecal incontinence (FI) is a prevalent and distressing condition with restricted access to specialized biofeedback therapy. Home-based biofeedback devices constitute a potential solution to enhance treatment accessibility; however, evidence from sham-controlled trials assessing their physiological effects remains scarce.

We conducted a single-center exploratory pilot study with a sham control involving women diagnosed with fecal incontinence. Baseline and post-treatment assessments included anorectal manometry, endoanal ultrasound, and evaluations of clinical symptoms. Subjects were allocated to either the intervention or sham therapy group and performed home training sessions six times per week over a period of 12 weeks. Adherence to the training regimen was monitored via a mobile application.

A total of 67 patients were screened, and 14 were assigned to intervention (n = 8) or sham control (n = 6). Twelve participants completed the study (six in each group). Improvements in anorectal manometric parameters were observed in the intervention group compared with the sham group, although the differences did not reach statistical significance. Clinical symptom scores also showed greater improvement in the intervention group. App-based monitoring demonstrated high adherence to home training, with an average of 5.5 training sessions per week and an overall adherence rate of 91%.

Home-based electrical biofeedback therapy was associated with positive trends in both anorectal physiological parameters and clinical symptom scores in women with fecal incontinence. These preliminary findings provide a basis for further investigation into home-based rehabilitation support strategies within controlled pelvic floor rehabilitation programs through larger randomized controlled trials.