Rectal expulsion device may predict outcomes in patients with chronic constipation
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SAN DIEGO — An investigational, point-of-care rectal expulsion device may help determine whether patients with chronic constipation will improve with pelvic floor physical therapy, according to data presented at Digestive Disease Week 2022.
“[Rectal expulsion device (RED)] was specifically designed to simplify and pull the tertiary care paradigm of anorectal function testing downstream to any general gastroenterologists’ medical office for patients with chronic constipation,” Eric D. Shah, MD, MBA, assistant professor at Dartmouth College Geisel School of Medicine and Dartmouth-Hitchcock Medical Center in New Hampshire, told Healio.
From May 2020 to June 2021, Shah and colleagues enrolled patients who were referred to general gastroenterology, met Rome IV criteria for functional constipation and failed fiber/laxatives for more than 2 weeks. Thirty-nine patients were included in the feasibility phase to develop use-case protocol, 60 were enrolled in the subsequent blinded validation phase and 52 patients (mean age, 46.9 years; 94.2% women) were included in the intention-to-treat analysis.
Participants were evaluated after insertion of the single-use, self-inflating RED, with time to expel measured in a left lateral position. Patients who failed to expel RED within 120 seconds then attempted to expel the device in a seated position.
All patients participated in pelvic floor physical therapy, and at 12 weeks investigators measured outcomes, which included global clinical response (Patient Assessment of Constipation Symptoms score reduction > 0.75 vs. baseline), improvement in health-related quality-of-life (HRQoL; Patient Assessment of Constipation-Quality of Life score reduction > 1) and complete spontaneous bowel movement frequency (CSBM).
Results showed RED predicted clinical response [generalized area under the curve (gAUC) = 0.67; 95% CI, 0.58-0.76], HRQoL response (gAUC = 0.67; 95% CI, 0.58-0.77) and CSBM response (gAUC = 0.63; 95% CI, 0.57-0.71) in the left lateral position. An abnormal RED in this position, defined as expulsion within 5 seconds or after more than 120 seconds, predicted 48.9% clinical response to physical therapy vs. 8.9% with normal RED.
According to researchers, adding a subsequent seated maneuver strengthened the predicted clinical response (71.1% among patients retaining RED > 13 seconds).
“We demonstrated that RED appears capable of predicting patient outcomes with pelvic floor physical therapy delivered in the community, thereby allowing gastroenterologists to rapidly triage care for patients with chronic constipation and help patients break the cycle of ineffective, rotating fiber and laxatives,” Shah said.
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Shah ED, et al. Abstract 955. Presented at: Digestive Disease Week; May 21-24, 2022; San Diego (hybrid meeting).
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