Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence

Launched by AUGUSTA UNIVERSITY · Mar 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat conditions like fecal incontinence (inability to control bowel movements), urinary incontinence (inability to control urination), and dyssynergic defecation (difficulty coordinating bowel movements). The researchers are testing a home biofeedback therapy system that includes a wireless device and a mobile app to help patients manage these conditions from the comfort of their own homes. The goal is to see if this home therapy is effective and safe compared to the traditional method that requires multiple visits to a clinic.

To participate in the trial, you must be at least 18 years old and have experienced symptoms related to these conditions for at least six months. For fecal incontinence, you should have at least one episode per week, while for urinary incontinence, you should have had at least two episodes over two weeks. Participants will receive training on how to use the biofeedback system and will be monitored throughout the study. This trial aims to make treatment more accessible and cost-effective for patients who currently struggle to get the help they need.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Inclusion Criteria for patients with constipation and dyssynergic defecation
• • 1. Minimum age of 18 years
• • 2. 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.
• • Inclusion Criteria for patients with fecal incontinence
• • 1. Minimum age of 18 years
• • 2. Recurrent episodes of fecal incontinence for six months
• • 3. No colonic mucosal disease
• • 4. On a two-week, prospective stool diary, patient reports at least one episode of fecal incontinence per week
• • Inclusion Criteria for patients with urinary incontinence
• • 1. Minimum age of 18 years
• • 2. Recurrent episodes of urinary incontinence for three months
• • 3. Stress, urge or mixed urinary incontinence, with at least 2 episodes of urinary incontinence on a 14-day urinary incontinence diary
• Exclusion Criteria:
• • Exclusion criteria for patients with constipation and dyssynergic defecation
• • 1. Evidence of structural or metabolic disease that could cause constipation, as assessed by colonoscopy or barium enema and routine hematological, biochemical, and thyroid function tests
• • 2. Use of opioids within the previous 2 weeks
• • 3. Severe cardiac or renal disease
• • 4. Neurological diseases such as multiple sclerosis or stroke
• • 5. Rectal prolapse or active anal fissures
• • 6. Alternating pattern of constipation and diarrhea
• • 7. Pregnant women or nursing mothers
• • Exclusion criteria for patients with fecal incontinence Severe diarrhea with Bristol Stool consistency ≥ Type 6 2. On opioids (except on stable doses \> 3months) 3. Active depression 4. Comorbid illnesses, severe cardiac disease, chronic renal failure or severe Chronic Obstructive Pulmonary Disease (COPD) 5. Ulcerative and Crohn's colitis 6. Rectal prolapse or active anal fissure 7. Pregnant women or nursing mothers
• • Exclusion criteria for patients with urinary incontinence
• • 1. Continuous urine leakage
• • 2. Active depression
• • 3. Comorbid illnesses, severe cardiac disease, chronic renal failure or severe COPD
• • 4. Rectal prolapse or active anal fissure
• • 5. Pregnant women or nursing mothers