Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence: Randomized Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fecal Incontinence
- Sponsor
- Augusta University
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- the number of Urinary Incontinence (UI) episodes for UI group
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief 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
- 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
- To compare the efficacy and safety of home biofeedback therapy system with the standard of care, office biofeedback therapy
- To assess the cost-effectiveness of home biofeedback therapy.
Detailed Description
Biofeedback therapy is an effective treatment for the management of patients with constipation and dyssynergic defecation, urinary incontinence, and fecal incontinence, problems that affect 25% of the population in USA. However, it is labor-intensive, costly, requires multiple office or hospital visits, is not widely available to the vast majority of patients in the community, and is not covered by many insurance companies. It is therefore imperative that a more pragmatic biofeedback treatment program that can be administered at home ought to be developed. Our previous studies have shown that home biofeedback training can be just as useful as office-based training, both for constipation with dyssynergia and fecal incontinence. These studies were however performed with older technology that included placement of anal probes connected to hand-held monitors with a liquid crystal display of flashing lights indicating changes in anal pressures. However, these methods are cumbersome and not user-friendly. Further, there is no commercially available home biofeedback system for dyssynergic defecation. The advent of newer digital technology using cellphone app-based applications, with real time animations and pictorial displays of anorectal anatomical changes than the traditional liquid crystal display (LCD) lights and computer monitors, if adopted, could immensely improve our ability to provide biofeedback training. Also, the interactive images of the human anatomy that are both dynamic and change in real time during the biofeedback maneuvers can prove to be a significant advance over line tracings showing pressure or electromyogram (EMG) changes that many patients find it difficult to comprehend. These animated real time images could enable the patient to visualize and directly connect with their anal or rectal or pelvic floor muscle dysfunction that is causing their bowel or urinary problem. Also, the use of Bluetooth technology will enable wireless transmission of the pressure changes from inside the body to a cellphone display system, avoiding the hassles of connecting a probe with a hand-held device, to view changes. Further, the ability to provide voice guided instructions using the cellphone application (APP) will provide a structured treatment program on how to perform biofeedback training at home that mirrors the office biofeedback training. A 3 sensor electronic anorectal probe with a balloon will be placed in the rectum for assessment of anal and rectal pressures, and this will communicate wirelessly with the cellphone app. This new home biofeedback system could significantly improve our current method of performing biofeedback training. Our specific aims are: 1) To test the feasibility, efficacy and safety of a wireless anorectal probe, and a cellphone app-based and Bluetooth interfaced, voice guided home biofeedback training system. 2) To compare the efficacy and safety of home biofeedback therapy with the standard of care office biofeedback therapy for the treatment of patients with dyssynergic constipation, fecal incontinence, and urinary incontinence; 3) To examine and compare the cost-effectiveness of home biofeedback therapy with office biofeedback therapy, in each of the 3 patient cohorts. Our overall hypothesis is that Home Biofeedback Therapy (HBT) is non-inferior to Office-Biofeedback Therapy (OBT), but is more user friendly, easy to administer, and cost effective for the management of patients with constipation and dyssynergic defecation, fecal incontinence and urinary incontinence.
Investigators
Satish Rao
Professor of Medicine
Augusta University
Eligibility Criteria
Inclusion Criteria
- •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)
- •Lumpy or hard stools (Form 1 of 2 on the Bristol Stool Scale) with 25% of BM
- •Sensation of incomplete evacuation with 25% of BM
- •Sensation of anorectal obstruction/blockage with 25% of BM
- •Manual maneuvers to facilitate defecation with 25% of BM
- •\< 3 Spontaneous bowel movements per week
- •Patients must demonstrate dyssynergic pattern of defecation (Types I-IV), during repeated attempts to defecate, and defined as a paradoxical increase in anal sphincter pressure (anal contraction), or less than 20% relaxation of the resting anal sphincter pressure, or inadequate propulsive forces during anorectal manometry.
Exclusion Criteria
- •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
- •Neurological diseases such as multiple sclerosis or stroke
- •Rectal prolapse or active anal fissures
- •Alternating pattern of constipation and diarrhea
- •Pregnant women or nursing mothers
- •Exclusion criteria for patients with fecal incontinence Severe diarrhea with Bristol Stool consistency ≥ Type 6
- •On opioids (except on stable doses \> 3months)
Outcomes
Primary Outcomes
the number of Urinary Incontinence (UI) episodes for UI group
Time Frame: 12 weeks (long term)
A responder for UI is defined as an individual reporting at least 50% reduction in weekly number of UI episodes
The number of complete spontaneous bowel movements (CSBM) per week for patients with dyssynergic defecation
Time Frame: 12 weeks (long term)
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
the number of fecal incontinence (FI) episodes for the FI group
Time Frame: 12 weeks (long term)
A responder for FI is defined as an individual reporting at least 50% reduction in weekly number of FI episodes
Secondary Outcomes
- straining effort (1-3 scale) for patients with dyssynergic defecation(6 weeks & 12 weeks)
- International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) for patients with urinary incontinence(6 weeks & 12 weeks)
- Number of spontaneous bowel movements (SBM) for patients with dyssynergic defecation(6 weeks & 12 weeks)
- Anal Sphincter Function-Anal Resting Pressure for patients within all 3 groups(6 weeks)
- Rectal Sensation- Desire to defecate for patients within all 3 groups(6 weeks)
- MEP Index The area under the curve of the Motor Evoked Potential (MEP) response for patients within all 3 groups(6 weeks)
- Global Assessment-Visual Analog Scale of urinary symptoms for patients with urinary incontinence(6 weeks and 12 weeks)
- stool frequency for the patients with dyssynergic defecation and fecal incontinence(6 weeks & 12 weeks)
- Proportion of patients who used digital maneuver with stooling for patients with dyssynergic defecation(6 weeks & 12 weeks)
- Patient Assessment of Constipation Symptoms (PAC-SYM) for patients with dyssynergic defecation(6 weeks & 12 weeks)
- Patient Assessment of Constipation - Quality of Life (PAC-QoL) for patients with dyssynergic defecation(6 weeks & 12 weeks)
- International Consultation on Incontinence Questionnaire-Bowels (ICIQ-B) for patients with fecal incontinence(6 weeks & 12 weeks)
- Rectal Sensation-First Sensation (volume of air) for patients within all 3 groups(6 weeks)
- stool consistence for the patients with dyssynergic defecation and fecal incontinence(6 weeks & 12 weeks)
- Rectal Sensation-Maximum tolerable volume for patients within all 3 groups(6 weeks)
- Rectal Compliance for patients within all 3 groups(6 weeks)
- Amplitudes (Millivolts of the nerve) for lumbo-rectal Motor Evoked Potential (MEP) for patients within all 3 groups(6 weeks)
- International Consultation on Incontinence Questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) for patients with urinary incontinence(6 weeks & 12 weeks)
- Fecal Incontinence Severity Index (FISI) for patients with fecal incontinence(6 weeks & 12 weeks)
- Anal Sphincter Function-Sustained Squeeze Pressure for patients within all 3 groups(6 weeks)
- Anal Sphincter Function-Squeeze Pressure for patients within all 3 groups(6 weeks)
- Rectal Sensation-Urgency to Defecate for patients within all 3 groups(6 weeks)
- Psychological Function Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety Questionnaire for patients within all 3 groups(6 weeks)
- Psychological Function PROMIS Depression Questionnaire for patients within all 3 groups(6 weeks)
- Fecal Incontinence Severity Sore (FISS) for patients with fecal incontinence(6 weeks & 12 weeks)
- Fecal Incontinence Quality OF Life Scale (FIQOL) for patients with fecal incontinence(6 weeks & 12 weeks)
- Psychological Function PROMIS Efficacy Questionnaire for patients within all 3 groups(6 weeks)
- Global Assessment of bowel satisfaction-Visual Analog Scale for patients with fecal incontinence and dyssynergic defecation(6 weeks and 12 weeks)
- Global Assessment of urinary symptoms for patients with urinary incontinence(6 weeks and 12 weeks)
- Amplitudes (Millivolts of the nerve) for sacro-rectal Motor Evoked Potential (MEP) for patients within all 3 groups(6 weeks)
- Global Assessment of bowel satisfaction for patients with fecal incontinence and dyssynergic defecation(6 weeks and 12 weeks)
- Cost effectiveness analysis for patients within all 3 groups(6 weeks)