NCT05771597 Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence
| NCT ID | NCT05771597 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Augusta University |
| Condition | Fecal Incontinence |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2023-03-27 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2023-03-27 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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
Contact & Investigator
Satish Rao, MD, PhD
PRINCIPAL INVESTIGATOR
Augusta University
Frequently Asked Questions
Who can join the NCT05771597 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fecal Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05771597 currently recruiting?
Yes, NCT05771597 is actively recruiting participants. Contact the research team at srao@augusta.edu for enrollment information.
Where is the NCT05771597 trial being conducted?
This trial is being conducted at Augusta, United States.
Who is sponsoring the NCT05771597 clinical trial?
NCT05771597 is sponsored by Augusta University. The principal investigator is Satish Rao, MD, PhD at Augusta University. The trial plans to enroll 72 participants.