Home biofeedback therapy for managing bowel and urinary issues
Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence: Randomized Study
This study is testing a new home therapy using a wireless device and a phone app to help people with bowel and urinary issues feel better and see if it's easier and cheaper than going to the doctor.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Augusta University Academic / other |
| Locations | 1 site (Augusta, Georgia) |
| Trial ID | NCT05771597 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of a wireless anorectal biofeedback device combined with a cellphone app for patients suffering from dyssynergic defecation, fecal incontinence, and urinary incontinence. The goal is to provide a more accessible and cost-effective alternative to traditional office-based biofeedback therapy, which is often labor-intensive and not widely available. Participants will be assessed for improvements in their symptoms and the overall cost-effectiveness of this home-based approach compared to standard care. The study aims to leverage modern technology to enhance patient engagement and treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who meet the Rome IV criteria for functional constipation and demonstrate a dyssynergic pattern of defecation.
Not a fit: Patients who do not have dyssynergic defecation or those with other unrelated gastrointestinal or urinary conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide patients with a more convenient and effective way to manage their bowel and urinary issues from home.
How similar studies have performed: Previous studies have shown that home biofeedback training can be effective, although this specific approach using newer technology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 movements per week 3. 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. * Dyssynergic pattern of defecation on anorectal manometry plus one or more of the following criteria: * Inability to expel an artificial stool (50 mL water-filled balloon) within 1 minute. * Prolonged colonic transit time on wireless motility capsule (\>59 hours) or \>5 markers retained on a colonic transit study. * Inability to evacuate or ≥ 50% retention of barium during defecography. Inclusion Criteria for patients with fecal incontinence 1. Minimum age of 18 years 2. Recurrent episodes of fecal incontinence for six months 3. No colonic mucosal disease 4. On a two-week, prospective stool diary, patient reports at least one episode of fecal incontinence per week Inclusion Criteria for patients with urinary incontinence 1. Minimum age of 18 years 2. Recurrent episodes of urinary incontinence for three months 3. Stress, urge or mixed urinary incontinence, with at least 2 episodes of urinary incontinence on a 14-day urinary incontinence diary Exclusion Criteria: * Exclusion criteria for patients with constipation and dyssynergic defecation 1. 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 2. Use of opioids within the previous 2 weeks 3. Severe cardiac or renal disease 4. Neurological diseases such as multiple sclerosis or stroke 5. Rectal prolapse or active anal fissures 6. Alternating pattern of constipation and diarrhea 7. Pregnant women or nursing mothers * Exclusion criteria for patients with fecal incontinence Severe diarrhea with Bristol Stool consistency ≥ Type 6 2. On opioids (except on stable doses \> 3months) 3. Active depression 4. Comorbid illnesses, severe cardiac disease, chronic renal failure or severe Chronic Obstructive Pulmonary Disease (COPD) 5. Ulcerative and Crohn's colitis 6. Rectal prolapse or active anal fissure 7. Pregnant women or nursing mothers * Exclusion criteria for patients with urinary incontinence 1. Continuous urine leakage 2. Active depression 3. Comorbid illnesses, severe cardiac disease, chronic renal failure or severe COPD 4. Rectal prolapse or active anal fissure 5. Pregnant women or nursing mothers
Where this trial is running
Augusta, Georgia
- Augusta University — Augusta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Satish Rao, MD, PhD — Augusta University
- Study coordinator: Satish Rao, MD, PhD
- Email: srao@augusta.edu
- Phone: 706-721-2239
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.