Is Home Biofeedback Training Useful for Fecal Incontinence: Preliminary Fesults of RCT With New Home Device

Abstract

Introduction: Biofeedback therapy (BT) is useful in fecal incontinence (FI), but it is labor intensive, not widely available and reimbursement is problematic. We tested the efficacy of home device assisted BT against standard office BT. Methods: Patients with FI (at least 1 episode / week) were randomized to office BT or home BT using a novel biofeedback device (InToneMV, InControl Medical, WI, USA). Home device consists of a probe with balloon, a pump for balloon inflation, a hand held monitor with voice guided therapy, and both mechanical and electrical stimulation of anal sphincters. Home BT patients were asked to use home device twice daily for 20 minute session. Office BT patients practiced Kegel exercise twice daily at home and had 6, one hour, weekly office BT consisting of anal strengthening, endurance training and coordination training for 6 weeks. All participants kept daily stool diaries. Bowel symptoms, fecal incontinence severity index (FISI), fecal incontinence and constipation assessment (FICA), subject's global assessment (SGA) and physiological changes (anorectal manometry) were assessed at baseline and post-treatment period. Responder was defined as ≥50% decrease in weekly FI episodes compared to baseline. Results: Eighteen (16 females, 63.6±13.4 years old) FI patients were enrolled: 11 (home BT) and 7 (office BT). There were 6/11 (55%) responders in Home BT and 3/7(43%) in Office BT (p=1.000). In Home BT, FI symptom severity (visual analog scale, VAS) improved in 10 (91%) and unchanged in 1 (9%), compared to 3 (43%) improved in Office BT and was unchanged in 1 (17%) and worse in 3 (43%). Similarly, 9% reported completely relief and 64% reported considerable relief with Home BT compared to 29% reported considerable relief with Office BT (Table 1). The mean FISI score increased and FICA score decreased in Home BT when compared to baseline (3.6 and 3.3, p=0.016 and p=0.033) and in Office BT (1.0 and 1.2 p=0.435 and p=0.330). The mean anal resting, maximal squeeze and sustained squeeze pressure increases were comparable (6.8, 25.3 and 5.21 mmHg in Home BT and 21.3, 37.6 and 14.4mmHg in Office BT respectively).Table: Table. Patients' self-assessment of the treatment effectConclusion: Home BT using a voice guided program of mechanical and electrical stimulation is a promising approach for treatment of FI, and provides comparable physiologic and somewhat better symptomatic benefit when compared to office BT. The convenience of home BT may prove beneficial in long term and reduce health care burden.