D0260 - Clinical Utility of Anorectal Manometry and Balloon Expulsion Testing to Predict Outcomes With Community-Based Pelvic Floor Physical Therapy: A Pragmatic Clinical Trial of Patients With Chronic Constipation

Award: Outstanding Research Award in the Functional Bowel Disease Category

Award: Presidential Poster Award

Eric D. Shah, MD, MBA, FACG¹, Elizabeth Pelletier, RN, BSN¹, Carol Greeley, RN¹, Emily Sieglinger, APRN¹, Jamie Sanchez, APRN¹, Kayla Northam, APRN¹, Jessica Perrone, MPAS, PA-C¹, Michael A. Curley, MD¹, Tracy Ostler, MS¹, Aimee R. Burnett Greeley, PT, MPH¹, Pablo Martinez-Camblor, PhD¹, William D. Chey, MD^2
1Dartmouth Health, Lebanon, NH; ²Michigan Medicine, Ann Arbor, MI

Introduction: Chronic constipation is a common reason for referral to community and general gastroenterology practice. We aimed to assess the clinical utility of anorectal manometry (ARM) and balloon expulsion time (BET) to predict outcomes with up-front, community-based pelvic floor physical therapy as the next best step to manage chronic constipation among patients failing an empiric trial of soluble fiber supplementation or osmotic laxatives.

Methods: 60 treatment-naïve patients (mean age 46.4±17.6 years; 93.3% women) enrolled between January to June 2021 that were referred to general gastroenterology meeting Rome IV functional constipation criteria and failing two weeks of soluble fiber supplementation or osmotic laxatives. All patients underwent ARM and BET (following the London protocol) followed by pelvic floor physical therapy (following a simplified community-based ANMS/ESNM protocol standardized and monitored in a preceding feasibility study enrolling 39 patients). All patients maintained stable diet and osmotic laxatives during the study, with a rescue regimen of secretory laxatives no more than 2 days per week. We assessed outcomes at baseline and 12-weeks. The primary endpoint was clinical response defined on whether patients achieved the minimal clinically important difference at 12-weeks vs. baseline on a valid global endpoint appropriate to chronic constipation trials (Patient Assessment of Constipation Symptoms [PAC-SYM] score reduction >0.75).

Results: 53 patients completed pelvic floor physical therapy and symptom assessments. Balloon expulsion time and dyssynergic patterns (ARM) did not inform clinical outcomes (area-under-the-curve[AUC]< 0.6 on these parameters). BET poorly predicted outcomes as a single test (AUC=0.54 [95% confidence interval[CI] 0.38-0.69]). Maximum squeeze pressure (achieving >192.5mmHg on at least 1 of 3 squeeze attempts; sensitivity 47.6%; specificity 93.9%) and squeeze duration (maintaining 50% of squeeze pressure for >20 seconds; sensitivity 71.4%; specificity 58.1%) were the strongest predictors of clinical outcomes. Adding BET to squeeze profiles (abnormal BET classified as expulsion LESS THAN 6.5 seconds) resulted in greater predictive accuracy (AUC=0.75 (95% CI 0.59-0.90).

Discussion: Squeeze profiles on ARM, rather than BET or dyssynergic manometric patterns, were the strongest predictors of clinical response with pelvic floor physical therapy delivered in the community as an up-front therapy to manage chronic constipation.


Disclosures:


Eric D. Shah, MD, MBA, FACG¹, Elizabeth Pelletier, RN, BSN¹, Carol Greeley, RN¹, Emily Sieglinger, APRN¹, Jamie Sanchez, APRN¹, Kayla Northam, APRN¹, Jessica Perrone, MPAS, PA-C¹, Michael A. Curley, MD¹, Tracy Ostler, MS¹, Aimee R. Burnett Greeley, PT, MPH¹, Pablo Martinez-Camblor, PhD¹, William D. Chey, MD². D0260 - Clinical Utility of Anorectal Manometry and Balloon Expulsion Testing to Predict Outcomes With Community-Based Pelvic Floor Physical Therapy: A Pragmatic Clinical Trial of Patients With Chronic Constipation, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.