Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence: Randomized Study
Biofeedback therapy is an effective treatment for the management of patients with dyssynergic defecation and constipation, urinary incontinence (UI), and fecal incontinence (FI). It is labor-intensive, costly, requires multiple office or hospital visits, is not easily available to the vast majority of patients in the community, and is not covered by many insurance companies. The purpose of this study is to 1. Evaluate home biofeedback therapy for patients with either constipation and dyssynergic defecation or urinary leakage or stool leakage by assessing the efficacy and safety of a wireless anorectal biofeedback device, and a cellphone app-based and voice guided home biofeedback training system 2. To compare the efficacy and safety of home biofeedback therapy system with the standard of care, office biofeedback therapy 3. To assess the cost-effectiveness of home biofeedback therapy.
• Inclusion Criteria for patients with constipation and dyssynergic defecation
∙ Minimum age of 18 years
‣ Meet Rome IV criteria for functional constipation (≥ 2 of following 6 symptoms) with symptom onset of 6 months on prospective stool diary
• Straining with 25% of bowel movements (BM)
• Lumpy or hard stools (Form 1 of 2 on the Bristol Stool Scale) with 25% of BM
• Sensation of incomplete evacuation with 25% of BM
• Sensation of anorectal obstruction/blockage with 25% of BM
• Manual maneuvers to facilitate defecation with 25% of BM
• \< 3 Spontaneous bowel movements per week 3. Patients must demonstrate dyssynergic pattern of defecation (Types I-IV), during repeated attempts to defecate, and defined as a paradoxical increase in anal sphincter pressure (anal contraction), or less than 20% relaxation of the resting anal sphincter pressure, or inadequate propulsive forces during anorectal manometry.
‣ Dyssynergic pattern of defecation on anorectal manometry plus one or more of the following criteria:
⁃ Inability to expel an artificial stool (50 mL water-filled balloon) within 1 minute.
⁃ Prolonged colonic transit time on wireless motility capsule (\>59 hours) or \>5 markers retained on a colonic transit study.
⁃ Inability to evacuate or ≥ 50% retention of barium during defecography.
⁃ Minimum age of 18 years
⁃ Recurrent episodes of fecal incontinence for six months
⁃ No colonic mucosal disease
⁃ On a two-week, prospective stool diary, patient reports at least one episode of fecal incontinence per week
⁃ Minimum age of 18 years
⁃ Recurrent episodes of urinary incontinence for three months
⁃ Stress, urge or mixed urinary incontinence, with at least 2 episodes of urinary incontinence on a 14-day urinary incontinence diary