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Point-of-care Anorectal Testing to Predict Outcomes With Biofeedback Therapy: Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04159350
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : June 23, 2020
American Gastroenterological Association
Information provided by (Responsible Party):
Eric.D.Shah, 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.

Condition or disease Intervention/treatment Phase
Constipation Device: Rectal Expulsion Device (RED) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Point-of-care Anorectal Testing to Predict Outcomes With Biofeedback Therapy: Clinical Trial
Actual Study Start Date : June 15, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: Rectal Expulsion Device (RED) Device: Rectal Expulsion Device (RED)

After a complete physical exam at bedside including a digital rectal exam, the patient is turned on their right side and RED is gently inserted into the rectum. The patient is then given one minute to expel RED while remaining on their right side. If the patient is unable to pass RED, the patient transfers to a commode and attempts to expel the device. If the device is not expelled, the device can be safely removed at bedside and the patient diagnosed with a biofeedback-responsive evacuation disorder.

The RED device is manufactured by Rose Medical (Grand Rapids, MI) under GMP conditions and final assembly is performed by In2Being (Saline, MI). The device contains accepted technologies that are already in use of humans, namely biomedical grade materials.

Primary Outcome Measures :
  1. Assessing Change of Global Constipation Symptoms at completion of physical therapy [ Time Frame: Week 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 with a low score indicating fewer constipation symptoms.

Secondary Outcome Measures :
  1. Measure Change in Bowel Movement Frequency at completion of physical therapy [ Time Frame: 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.

  2. Measure Change in Bowel Movement Form at completion of physical therapy [ Time Frame: 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 severe constipation and stool type 7 indicates severe diarrhea

  3. Measure Change in Severity of Straining for Bowel Movements at completion of physical therapy [ Time Frame: Week 12 ]
    Using the 11-point Likert scale at week 0 and week 12 measure the severity of straining during bowel movements. Lower scores indicate less straining. Higher scores indicate more straining.

Other Outcome Measures:
  1. Assess the Health Related Quality of Life at completion of physical therapy [ Time Frame: Week 12 ]
    Using the EuroQOL EQ-5D-5L assess the health related quality of life at week 0 and week 12. The scores can range from 5 - 25, with lower scores indicating better health for the patient that day.

  2. Assess work productivity at the completion of physical therapy [ Time Frame: Week 12 ]
    Using the WPAI:IBS-C instrument38 assess work productivity at week 0 and 12.

  3. Level of agreement between binary test results of RED and traditional lab-based testing [ Time Frame: 12 weeks ]
    Because RED is designed to produce similar results compared to traditional balloon expulsion, traditional balloon expulsion will be used as the gold standard in the primary analysis. However, no single test can identify dyssynergia in current clinical practice. Rome IV enables a diagnosis of dyssynergia based on agreement among lab-based anorectal function tests. Further, Rome IV criteria do not specify which specific manometric quantitative measures define abnormal anorectal manometry will be assessed. In exploratory analysis, the level of agreement between RED and anorectal manometry, including recto-anal index and anal relaxation during attempted defecation. The concordance between binary testing results using RED as a single device, compared to combination lab-based anorectal function testing will be evaluated, to gather preliminary data assessing the robustness of RED in diagnosing dyssynergia as a single device.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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?
    • 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 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04159350

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Contact: Eric D. Shah, MD 603-650-5261
Contact: Tracy L. Ostler, MS 603-653-9033

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United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Shari McBride    603-650-5261      
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
American Gastroenterological Association
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Principal Investigator: Eric D. Shah, MD Dartmouth-Hitchcock Medical Center
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Responsible Party: Eric.D.Shah, Director, Center for Gastrointestinal Motility, Esophageal and Swallowing Disorders, Dartmouth-Hitchcock Medical Center Identifier: NCT04159350    
Other Study ID Numbers: D19162
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive
Signs and Symptoms