Point-of-care Anorectal Testing to Predict Outcomes With Biofeedback Therapy: Clinical Trial
- Conditions
- Constipation
- Interventions
- Device: Rectal Expulsion Device (RED) - ValidationDevice: Rectal Expulsion Device (RED) - Feasibility
- Registration Number
- NCT04159350
- Lead Sponsor
- Dartmouth-Hitchcock Medical Center
- Brief Summary
To prospectively evaluate the clinical utility of baseline anorectal function testing using a point-of-care device in predicting response of chronically constipated patients to physical therapy biofeedback training.
- Detailed Description
Chronic constipation affects 10-20% of the US population and can impact quality-of-life to a similar degree as congestive heart failure or rheumatoid arthritis. Notably, 700,000 individuals present to the emergency department for constipation each year in the US and $10 billion is spent annually on laxative therapy. For symptomatic chronic constipation refractory to fiber or laxative therapy, clinical practice guidelines recommend physiological testing to identify abnormalities in anorectal function as the next step5. Abnormal anorectal function testing (including anorectal manometry and balloon expulsion testing) suggests an evacuation disorder, the most common of which is dyssynergic defecation or dyssynergia. Identification of patients with an evacuation disorder as a primary driver of constipation is important since therapy can then be targeted.
To enable standardized, accessible chronic constipation testing for general gastroenterologists, the investigators invented an office-based, point-of-care Rectal Expulsion Device (RED). By incorporating RED into a general gastroenterologist's outpatient visit, chronically constipated individuals with abnormal anorectal function can be identified quickly and directly triaged to biofeedback therapy. Thus, RED offers the possibility of disrupting the current treatment paradigm by enabling an initial biomarker based strategy for patients with chronic constipation. Before such a process of care can be realized, there is a critical need for prospective data to determine the best setting for anorectal function testing in the clinical care pathway. The investigators aim to prospectively evaluate the clinical utility of baseline anorectal function testing using RED in identifying chronically constipated patients with evacuation disorders who would benefit from biofeedback therapy.
The investigators will conduct a 12-week clinical trial enrolling individuals with laxative-refractory chronic constipation. All study participants will undergo RED and traditional lab-based testing at baseline, followed by a standardized three-session biofeedback protocol for dyssynergia.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 99
-
individuals aged 18-80 with a body mass index of 18 to 40 kg/m2 and a primary ICD-10 diagnosis for constipation (K59*) or referral for constipation.
- Does the patient meet Rome IV criteria for functional constipation (FC)?
- Does the patient report that fiber or laxative therapy has been ineffective to treat constipation in a documented treatment trial for at least two weeks prior to screening?
- Patient is already scheduled for anorectal manometry and physical therapy as part of routine care.
- The patient must agree to maintain their current dietary fiber intake and osmotic or bulk-forming laxative regimen (if any) throughout the trial
- The patient must agree to use stimulant laxatives (such as magnesium citrate [Milk of Magnesia], senna or bisacodyl [Dulcolax]) NO MORE THAN two days per week during the trial
- Patient must be able to participate in physical therapy for biofeedback
- Individuals must have health insurance coverage to undergo anorectal function testing and biofeedback therapy as part of their non-study routine clinical care
- adults unable to consent, individuals who are not yet adults, pregnant women, and prisoners, as they would be unable to reasonably comply with physical therapy within the duration of the study and would thus undergo unnecessary testing.
- Patient must NOT have tried biofeedback therapy or undergone anorectal manometry previously
- Patient must NOT report prior SURGERY involving the colon or rectum (including surgery for anal fissure, rectal prolapse)
- Patient must NOT recent opioid use within 30 days of enrollment
- Patient must NOT report a neurodegenerative condition (i.e. Parkinson's disease, dementia, multiple sclerosis, spinal cord injury) or uncontrolled inflammatory bowel disease
- Patient must NOT have used linaclotide (Linzess), lubiprostone (Amitiza), plecanatide (Trulance), tegaserod (Zelnorm) or prucalopride (Motegrity) within 30 days prior to enrollment. Patients MUST agree not to use these agents during the trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Rectal Expulsion Device (RED) - Validation Rectal Expulsion Device (RED) - Validation Validation Phase. Rectal Expulsion Device (RED) - Feasibility Rectal Expulsion Device (RED) - Feasibility Feasibility Phase.
- Primary Outcome Measures
Name Time Method Assessing Change of Global Constipation Symptoms at completion of physical therapy Week 0 and 12 The Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire is a short, easily-completed instrument for assessing global constipation symptoms. A total PAC-SYM score ranges from 0 to 48.
- Secondary Outcome Measures
Name Time Method Measure Change in Severity of Abdominal Discomfort for Bowel Movements at completion of physical therapy Week 0 and Week 12 Using the 5-point Likert scale at week 0 and week 12 to measure the severity of abdominal discomfort during bowel movements. Lower scores indicate less abdominal discomfort. Higher scores indicate more abdominal discomfort.
Measure Change in Severity of Straining for Bowel Movements at completion of physical therapy Week 0 and Week 12 Using the 5-point Likert scale at week 0 and week 12 to measure the severity of straining during bowel movements. Lower scores indicate less straining. Higher scores indicate more straining.
Measure Change in Severity of Bloating for Bowel Movements at completion of physical therapy Week 0 and Week 12 Using the 5-point Likert scale at week 0 and week 12 to measure the severity of bloating. Lower scores indicate less bloating. Higher scores indicate more bloating.
Measure Change in Bowel Movement Frequency at completion of physical therapy Week 0 and Week 12 Measure 7-day average of bowel movement frequency (number of complete spontaneous bowel movements per week and number of spontaneous bowel movements per week). This information will be gathered at week 0 and week 12 in order to measure the change.
Measure Change in Bowel Movement Form at completion of physical therapy Week 0 and Week 12 Using the Bristol Stool Scale at week 0 and week 12 measure the change in bowel movement form. The scale breaks down bowel movements into seven different categories based on the appearance of the stool. Stool type 1 indicates hard, lumpy stool and stool type 7 indicates watery stool.
Measure Change in Severity of Constipation Severity for Bowel Movements at completion of physical therapy Week 0 and Week 12 Using the 5-point Likert scale at week 0 and week 12 to measure the severity of straining during bowel movements. Lower scores indicate less severity. Higher scores indicate more severity.
Assess the Level of Treatment Satisfaction Week 12 Using the 5-point Likert scale at week 12 to measure the level of treatment satisfaction. Lower scores indicate less satisfaction. Higher scores indicate more satisfaction.
Trial Locations
- Locations (1)
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States