Point-of-care Anorectal Testing to Predict Outcomes With Biofeedback Therapy: Clinical Trial
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

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.
    

Intervention name(s): Rectal Expulsion Device (RED) - Feasibility; Rectal Expulsion Device (RED) - Validation
Intervention type(s): Device; Device
Intervention description(s): 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.; 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.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic