Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAugusta University
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Home Biofeedback therapy
- Office biofeedback therapy
Treatment groups
72 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov