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

NCT04159350 | Completed

• 1 other identifier: D19162
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Measure Change in Bowel Movement Frequency at completion of physical therapy

  Week 0 and Week 12

• Measure Change in Bowel Movement Form at completion of physical therapy

  Week 0 and Week 12

• Measure Change in Severity of Straining for Bowel Movements at completion of physical therapy

  Week 0 and Week 12

• Measure Change in Severity of Abdominal Discomfort for Bowel Movements at completion of physical therapy

  Week 0 and Week 12

• Measure Change in Severity of Bloating for Bowel Movements at completion of physical therapy

  Week 0 and Week 12

Other Outcomes (5)

• Assess the General Health Related Quality of Life at completion of physical therapy

  Week 0 and 12

• Assess the Constipation-Related Health Related Quality of Life at completion of physical therapy

  Week 0 and 12

• Assess work productivity

  Week 0 and 12

Study Arms (2)

Rectal Expulsion Device (RED) - Feasibility

EXPERIMENTAL

Feasibility Phase.

Device: Rectal Expulsion Device (RED) - Feasibility

Rectal Expulsion Device (RED) - Validation

EXPERIMENTAL

Validation Phase.

Device: Rectal Expulsion Device (RED) - Validation

Interventions

Rectal Expulsion Device (RED) - Feasibility DEVICE

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.

Rectal Expulsion Device (RED) - Feasibility

Rectal Expulsion Device (RED) - Validation DEVICE

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.

Rectal Expulsion Device (RED) - Validation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• American Gastroenterological Association: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (2)

• 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. 2023 Apr;21(4):1070-1081. doi: 10.1016/j.cgh.2022.05.014. Epub 2022 May 29.

  PMID: 35640864 DERIVED

• 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. 2023 Apr;21(4):1082-1090. doi: 10.1016/j.cgh.2022.03.022. Epub 2022 Mar 24.

  PMID: 35341952 DERIVED

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric D. Shah, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Gastrointestinal Motility, Esophageal and Swallowing Disorders

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 12, 2019
• Study Start: June 15, 2020
• Primary Completion: September 13, 2021
• Study Completion: September 13, 2021
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)