Actively Recruiting
Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence: Randomized Study
Led by Augusta University · Updated on 2023-03-16
72
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate home biofeedback therapy for patients with constipation and dyssynergic defecation, urinary leakage, or stool leakage. It focuses on assessing the effectiveness and safety of a wireless anorectal biofeedback device paired with a cellphone app that offers voice-guided training. The study also compares this home-based approach to the standard office biofeedback therapy and analyzes the cost-effectiveness of each method in managing these conditions. Participants will receive either home biofeedback therapy or office biofeedback therapy. In the home group, patients use a wireless anorectal probe and a smartphone app with voice instructions to perform exercises daily for six weeks. The office group attends weekly sessions where therapists provide feedback and training using traditional biofeedback methods. The study includes three patient groups: those with constipation and dyssynergic defecation, fecal incontinence, and urinary incontinence. Throughout the study, participants are monitored for changes in bowel movements, incontinence episodes, stool consistency, and quality of life measures using various questionnaires and assessments. Testing includes anorectal manometry and evaluations of anal sphincter function and rectal sensation. Safety and psychological effects are also tracked. The study spans short-term (6 weeks) and long-term (12 weeks) follow-up periods to assess outcomes and cost-effectiveness.
CONDITIONS
Brief 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 with symptoms for 6 months including straining, hard stools, incomplete evacuation, or blockage in at least 25% of bowel movements
- Demonstrate dyssynergic defecation patterns during anorectal manometry
- For fecal incontinence: recurrent episodes for at least 6 months with at least one episode per week on stool diary
- For urinary incontinence: recurrent episodes for at least 3 months, including stress, urge, or mixed types with at least 2 episodes on a 14-day diary
You will not qualify if you...
- Presence of structural or metabolic diseases causing constipation as shown by colonoscopy or imaging
- Use of opioids within 2 weeks before study
- Severe heart or kidney disease
- Neurological diseases like multiple sclerosis or stroke
- Rectal prolapse or active anal fissures
- Alternating constipation and diarrhea pattern
- Pregnant or nursing women
- Severe diarrhea (Bristol Stool scale type 6 or higher) for fecal incontinence group
- Active depression
- Severe chronic obstructive pulmonary disease or other serious comorbid illnesses
- Continuous urine leakage for urinary incontinence group
- Ulcerative or Crohn's colitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive biofeedback therapy either at home using a wireless anorectal probe with a smartphone app or in an office setting with a therapist. Home therapy involves daily sessions guided by voice instructions for six weeks, while office therapy consists of weekly sessions over six weeks.
Daily home sessions or weekly office visits depending on treatment group
Trial Site Locations
Total: 1 location
1
Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
Research Team
S
Satish Rao, MD, PhD
B
Bianca Marsh, BS
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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