Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence
Recruiting now · Not applicable
Conditions studied: Fecal Incontinence, Dyssynergic Defecation, Urinary Incontinence
In brief
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.
Key facts
- Study ID
- NCT05771597
- Run by
- Augusta University
- People needed
- 72
- Starts
- 2023-03-27
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2023-03-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Inclusion Criteria for patients with fecal incontinence
- 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
- Inclusion Criteria for patients with urinary incontinence
- 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
You may not qualify if…
- Exclusion criteria for patients with constipation and dyssynergic defecation
- 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
- Use of opioids within the previous 2 weeks
- Severe cardiac or renal disease
- Neurological diseases such as multiple sclerosis or stroke
- Rectal prolapse or active anal fissures
- Alternating pattern of constipation and diarrhea
- 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
- Continuous urine leakage
- Active depression
- Comorbid illnesses, severe cardiac disease, chronic renal failure or severe COPD
- Rectal prolapse or active anal fissure
- Pregnant women or nursing mothers
Where it is running
- Augusta University — Augusta, Georgia, United States (enrolling)
Full record on ClinicalTrials.gov
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