Randomized controlled trial of home biofeedback therapy versus office biofeedback therapy for fecal incontinence

• Published in: Neurogastroenterology and motility Vol. 33; no. 11; pp. e14168 - n/a
• Main Authors: Xiang, Xuelian, Sharma, Amol, Patcharatrakul, Tanisa, Yan, Yun, Karunaratne, Tennekoon, Parr, Rachel, Ayyala, Deepak Nag, Hall, Patricia, Rao, Satish S. C.
• Format: Journal Article
• Language: English
• Published: England Wiley Subscription Services, Inc 01-11-2021
• Subjects: Aged; Anal Canal - physiopathology; Anorectal; Biofeedback; biofeedback therapy; Biofeedback, Psychology - methods; Electrical stimuli; Fecal incontinence; Fecal Incontinence - physiopathology; Fecal Incontinence - therapy; Feces; Feedback; Female; home device; Humans; Intestine; Male; Manometry; Middle Aged; Patients; Physical training; Quality of life; Sphincter; Treatment Outcome; fecal incontinence; biofeedback therapy; home device
• ISSN: 1350-1925; 1365-2982
• DOI: 10.1111/nmo.14168

Background
Biofeedback therapy is useful for treatment of fecal incontinence (FI), but is not widely available and labor intensive. We investigated if home biofeedback therapy (HBT) is non‐inferior to office biofeedback therapy (OBT).
Methods
Patients with FI (≥1 episode/week) were randomized to HBT or OBT for 6 weeks. HBT was performed daily using novel device that provided resistance training and electrical stimulation with voice‐guided instructions. OBT consisted of six weekly sessions. Both methods involved anal strength, endurance, and coordination training. Primary outcome was change in weekly FI episodes. FI improvement was assessed with stool diaries, validated instruments (FISI, FISS, and ICIQ‐B), and anorectal manometry using intention‐to‐treat analysis.
Key Results
Thirty (F/M = 26/4) FI patients (20 in HBT, 10 in OBT) participated. Weekly FI episodes decreased significantly after HBT (Δ ± 95% confidence interval: 4.7 ± 1.8, compared with baseline, p = 0.003) and OBT (3.7 ± 1.6, p = 0.0003) and HBT was non‐inferior to OBT (p = 0.2). The FISI and FISS scores improved significantly in HBT group (p < 0.02). Bowel pattern, bowel control, and quality of life (QOL) domains (ICIQ‐B) improved significantly in HBT arm (p < 0.023). Resting and maximum squeeze sphincter pressures significantly improved in both HBT and OBT groups and sustained squeeze pressure in HBT, without group differences.
Conclusions & Inferences
Home biofeedback therapy is non‐inferior to OBT for FI treatment. Home biofeedback is safe, effective, improves QOL, and through increased access could facilitate improved management of FI.
Home biofeedback therapy (HBT) is non‐inferior to office biofeedback therapy for fecal incontinence (FI) treatment. Home biofeedback is safe, effective, and improves quality of life. HBT could increase patient access to care and facilitate improved management of FI.