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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Home Biofeedback therapy
Other interventionPatients will be given home biofeedback device to take home and practice biofeedback exercises at least twice a day for six weeks of therapy. 1. HBT for patients with constipation and dyssynergic defecation: Patients will attend one session of training on how to use the device followed by daily sessions at home for 6 weeks. After placing a probe into rectum, the patient sits on a commode, activates the smart phone app and follow the voice-guided instructions to perform diaphragmatic breathing exercises and push maneuvers with/without balloon distension. 2. HBT for patients with FI: Subject will receive training on how to use the home-trainer device and probe placement. The patient will be asked to follow a series of voice guided instructions consisting of performing short and long duration squeeze maneuvers over 25 minutes. 3. HBT for patients with UI: The instructions protocol as written above for patients with FI will be followed for UI patients as well.
Office biofeedback therapy
Other interventionPatients will receive traditional office biofeedback, once weekly, over six weeks. 1. OBT for patients with constipation and dyssynergic defecation: The patient will receive instructions on the diaphragmatic breathing techniques. Then the patient sits on a commode, coordination between push effort and the anal and pelvic floor relaxation is corrected by the therapist. The patients will receive visual and verbal feedback instructions from the therapist. 2. OBT for patients with FI: Patients will be taught Kegels and abdominal muscle exercises. Visual and verbal feedback techniques are used to reinforce the maneuvers. The patient is instructed to squeeze and to maintain this squeeze for as long as possible. 3. OBT for patients with UI: Biofeedback training is performed using the protocol and objectives as described above for FI training.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Home Biofeedback Therapy (HBT)Experimental treatment 1 intervention
Group B: Office Biofeedback Therapy (OBT)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
The number of complete spontaneous bowel movements (CSBM) per week for patients with dyssynergic defecation
A responder for dyssynergic defecation group is defined as as a subject who demonstrates both ≥ 1 complete spontaneous bowel movement/week and normalization of dyssynergic pattern
Time frame
6 weeks (short term)2
The number of complete spontaneous bowel movements (CSBM) per week for patients with dyssynergic defecation
A responder for dyssynergic defecation group is defined as as a subject who demonstrates both ≥ 1 complete spontaneous bowel movement/week and normalization of dyssynergic pattern
Time frame
12 weeks (long term)3
the number of fecal incontinence (FI) episodes for the FI group
A responder for FI is defined as an individual reporting at least 50% reduction in weekly number of FI episodes
Time frame
6 weeks (short term)4
the number of fecal incontinence (FI) episodes for the FI group
A responder for FI is defined as an individual reporting at least 50% reduction in weekly number of FI episodes
Time frame
12 weeks (long term)Secondary outcomes
1
stool frequency for the patients with dyssynergic defecation and fecal incontinence
Stool frequency-how often subjects have a bowel movement.
Time frame
6 weeks & 12 weeks2
stool consistence for the patients with dyssynergic defecation and fecal incontinence
Stool consistency (Bristol Stool scale, 1-7). 1, 2 very hard stool, 3- 5 normal, smooth stool, and 6-7 watery stool, 1, 2 indicates constipated stool consistency and 6,7 indicates stool consistency for diarrhea
Time frame
6 weeks & 12 weeks3
Number of spontaneous bowel movements (SBM) for patients with dyssynergic defecation
number of bowel movements that the subject feels complete evacuation.
Time frame
6 weeks & 12 weeks4
straining effort (1-3 scale) for patients with dyssynergic defecation
severity of straining effort during bowel movement; 1 = mild, 2 = moderate, 3 = severe. The higher score, the worse straining.
Time frame
6 weeks & 12 weeksSponsors and contacts
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Source ClinicalTrials.gov