Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence: Randomized Study
Augusta University
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 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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Inclusion Criteria for patients with constipation and dyssynergic defecation 1. Minimum age of 18 years 2. 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 moveme…
Interventions
- OtherHome Biofeedback therapy
Patients 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.
- OtherOffice biofeedback therapy
Patients 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.
Location
- Augusta UniversityAugusta, Georgia