Functional Bowel Disease

71 - Home Biofeedback Therapy Improves Fecal Incontinence Severity and Quality of Life in a Non-Inferiority Randomized Controlled Study

Wednesday, October 10
9:30 AM - 9:40 AM
Location: Terrace Ballroom 2-3 (level 400)

Category: Functional Bowel Disease
Amol Sharma, MD, Xuelian Xiang, MD, Yun Yan, MD, Tanisa Patcharatrakul, MD, Rachel Parr, MS, Satish S.C. Rao, MD, PhD
Augusta University Medical Center, Augusta, GA

Background: Biofeedback therapy (BT) is a useful treatment modality for fecal incontinence (FI), but it is labor-intensive, not widely available and poorly reimbursed. We assessed changes in FI severity and FI-quality of life (QOL) after treatment with home device-assisted BT (HBT) compared to standard office BT (OBT). 

Methods: Subjects with FI (>1 episode/week) were randomized to either six one-hour, weekly in-office BT sessions using HRM probe (Medtronics, MN) during the OBT arm or using a novel device (InToneMV, InControl Medical, WI, USA) at home in the HBT arm. The HBT device consists of a probe with balloon, a pump for balloon inflation, a hand-held monitor with voice-guided instructions, and both mechanical and electrical stimulation. HBT subjects received initial demonstration and instructions to perform 20-minute training daily. Daily Bowel symptoms, FI severity index (FISI), FI severity score (FISS), subject’s global assessment (SGA) and International Consultation on Incontinence Module Questionnaire-Bowels module (ICIQ-B) were assessed at baseline and post-treatment. 

Results: Thirty (F/M=26/4, 35-84 yrs) FI subjects were randomized HBT (n=20) and OBT (n=10). In HBT arm, SGA improved in 14 FI subjects (70%) and unchanged in 6 (30%), whereas in the OBT arm, it improved in 3 (30%), unchanged in 3 (30%), and worsened in 4 (40%). The mean FISI score increased significantly (p=0.005) and FISS score decreased (p=0.006) with HBT compared to baseline, both changes in FISI and FISS reflected significantly improved continence in HBT. Improvements in FISI (p=0.127) and FISS (p=0.181) were not significant in OBT arm. All three domains of the ICIQ-B (bowel pattern, bowel control, QOL) improved significantly in the HBT arm, but only QOL improved significantly in the OBT arm.

Conclusions: HBT significantly improves both FI severity and QOL, and these responses are non-inferior or slightly better than OBT. HBT is a safe and effective therapy for FI that would increase access to treatment and reduce health care burden in FI. Large multicenter studies should validate these findings.


Disclosures:
Amol Sharma indicated no relevant financial relationships.
Xuelian Xiang indicated no relevant financial relationships.
Yun Yan indicated no relevant financial relationships.
Tanisa Patcharatrakul indicated no relevant financial relationships.
Rachel Parr indicated no relevant financial relationships.
Satish Rao: In-Control Medical – Grant/Research Support.

Amol Sharma

M.D.
Medical College of Georgia/Augusta University
Augusta, Georgia

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