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

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.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Device: Rectal Expulsion Device (RED) - Feasibility; Device: Rectal Expulsion Device (RED) - Validation

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.

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rectal Expulsion Device (RED) - Feasibility; Feasibility Phase.	Device: Rectal Expulsion Device (RED) - Feasibility; After a complete physical exam at bedside including a digital rectal exam, the patient is turned on their side and RED is gently inserted into the rectum. The patient is then given one minute to expel RED while remaining on their 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.
Experimental: Rectal Expulsion Device (RED) - Validation; Validation Phase.	Device: Rectal Expulsion Device (RED) - Validation; After a complete physical exam at bedside including a digital rectal exam, the patient is turned on their LEFT side and RED is gently inserted into the rectum. The patient then attempts to expel RED while remaining on their 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing Change of Global Constipation Symptoms at completion of physical therapy	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.	Week 0 and 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure Change in Bowel Movement Frequency at completion of physical therapy	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.	Week 0 and Week 12
Measure Change in Bowel Movement Form at completion of physical therapy	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.	Week 0 and Week 12
Measure Change in Severity of Straining for Bowel Movements at completion of physical therapy	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.	Week 0 and Week 12
Measure Change in Severity of Abdominal Discomfort for Bowel Movements at completion of physical therapy	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.	Week 0 and Week 12
Measure Change in Severity of Bloating for Bowel Movements at completion of physical therapy	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.	Week 0 and Week 12
Measure Change in Severity of Constipation Severity for Bowel Movements at completion of physical therapy	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.	Week 0 and Week 12
Assess the Level of Treatment Satisfaction	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.	Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the General Health Related Quality of Life at completion of physical therapy	Using the EuroQOL EQ-5D-5L to 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.	Week 0 and 12
Assess the Constipation-Related Health Related Quality of Life at completion of physical therapy	Using the disease specific PAC-QOL to assess the health related quality of life at week 0 and week 12. The minimally important difference to define QoL treatment response in constipation trials is a reduction in composite score of at least 1.0.	Week 0 and 12
Assess work productivity	Using the WPAI:Constipation v2 instrument to assess work productivity at week 0 and 12.	Week 0 and 12
Level of agreement between binary test results of RED and traditional lab-based testing to detect dyssynergia	Rome IV and the IAWPG consensus protocol enables a diagnosis of dyssynergia based on agreement among lab-based anorectal function tests. The level of agreement between RED and anorectal manometry on anal relaxation during attempted defecation will be assessed on this outcome.	Week 0 and 12
Level of agreement between binary test results of RED and traditional lab-based testing to detect abnormal rectal sensation	Rome IV and the IAWPG consensus protocol enables a diagnosis of abnormal rectal sensation based on lab-based anorectal manometry. The level of agreement between RED and anorectal manometry on anal relaxation during attempted defecation will be assessed on this outcome.	Week 0 and 12

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: American Gastroenterological Association
• Investigators: Principal Investigator: Eric D. Shah, MD, Dartmouth-Hitchcock Medical Center

Publications and helpful links

General Publications

• Shah ED, Pelletier EA, Greeley C, Sieglinger EE, Sanchez JD, Northam KA, Perrone JA, Curley MA, Navas CM, Ostler TL, Burnett Greeley AR, Martinez-Camblor P, Baker JR, Chey WD. Utility of Anorectal Testing to Predict Outcomes With Pelvic Floor Physical Therapy in Chronic Constipation: Pragmatic Trial. Clin Gastroenterol Hepatol. 2022 May 29:S1542-3565(22)00524-9. doi: 10.1016/j.cgh.2022.05.014. Online ahead of print.
• Shah ED, Pelletier EA, Greeley C, Sieglinger EE, Sanchez JD, Northam KA, Perrone JA, Curley MA, Navas CM, Ostler TL, Burnett Greeley AR, Martinez-Camblor P, Baker JR, Harris A, Siegel CA, Chey WD. An Office-Based, Point-of-Care Test Predicts Treatment Outcomes With Community-Based Pelvic Floor Physical Therapy in Patients With Chronic Constipation. Clin Gastroenterol Hepatol. 2022 Mar 24:S1542-3565(22)00297-X. doi: 10.1016/j.cgh.2022.03.022. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2020
• Primary Completion (Actual): September 13, 2021
• Study Completion (Actual): September 13, 2021

Study Registration Dates

• First Submitted: November 6, 2019
• First Submitted That Met QC Criteria: November 7, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 18, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: D19162

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No