Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence (NCT05771597) | Clinical Trial Compass
RecruitingNot Applicable
Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence
United States72 participantsStarted 2023-03-27
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
â. Minimum age of 18 years
â. Meet Rome IV criteria for functional constipation (⼠2 of following 6 symptoms) with symptom onset of 6 months on prospective stool diary
â. Minimum age of 18 years
â. Recurrent episodes of fecal incontinence for six months
â. No colonic mucosal disease
â. On a two-week, prospective stool diary, patient reports at least one episode of fecal incontinence per week
â. Minimum age of 18 years
â. Recurrent episodes of urinary incontinence for three months
Exclusion criteria
â. 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
â. Use of opioids within the previous 2 weeks
What they're measuring
1
The number of complete spontaneous bowel movements (CSBM) per week for patients with dyssynergic defecation
Timeframe: 6 weeks (short term)
2
The number of complete spontaneous bowel movements (CSBM) per week for patients with dyssynergic defecation
Timeframe: 12 weeks (long term)
3
the number of fecal incontinence (FI) episodes for the FI group
Timeframe: 6 weeks (short term)
4
the number of fecal incontinence (FI) episodes for the FI group
Timeframe: 12 weeks (long term)
5
the number of Urinary Incontinence (UI) episodes for UI group
Timeframe: 6 weeks (short term)
6
the number of Urinary Incontinence (UI) episodes for UI group