Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this 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.
Sponsor: Augusta University
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Augusta
Source: ClinicalTrials.gov · NCT05771597 · last updated 2023-03-16