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

Constipation Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Constipation

• NCT number: NCT04159350
• Study type: Interventional
• Source: Dartmouth-Hitchcock Medical Center
• Status: Completed
• Phase: N/A
• Start date: June 15, 2020
• Completion date: September 13, 2021