Actively Recruiting
Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence
Led by Augusta University · Updated on 2023-03-16
72
Participants Needed
1
Research Sites
196 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- For constipation and dyssynergic defecation: meet Rome IV criteria for functional constipation with symptoms for at least 6 months
- Have a dyssynergic pattern of defecation confirmed by anorectal manometry and related tests
- For fecal incontinence: have recurrent episodes for at least 6 months and report at least one episode per week on a stool diary
- For urinary incontinence: have recurrent episodes for at least 3 months with at least 2 episodes recorded on a urinary incontinence diary
You will not qualify if you...
- Structural or metabolic diseases causing constipation based on colonoscopy or imaging and blood tests
- Use of opioids within the past 2 weeks (unless stable dose over 3 months for incontinence patients)
- Severe cardiac, renal, or pulmonary disease
- Neurological diseases such as multiple sclerosis or stroke
- Rectal prolapse or active anal fissures
- Alternating constipation and diarrhea pattern
- Severe diarrhea with Bristol Stool consistency type 6 or higher (for fecal incontinence patients)
- Active depression
- Ulcerative or Crohn's colitis
- Continuous urine leakage (for urinary incontinence patients)
- Pregnant women or nursing mothers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
Research Team
S
Satish Rao, MD, PhD
CONTACT
B
Bianca Marsh, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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