7 - Comparative Effectiveness of Biofeedback and Dextranomer/Hyaluronate Injection for Treatment of Fecal Incontinence: A Multicenter Randomized Controlled Trial

Award: ACG Outstanding Research Award in the Functional Bowel Disease Category

Adil Bharucha, MBBS, MD¹, Satish S. C.. Rao, MD, PhD², William Whitehead, PhD³, Isuzu Meyer, MD, MSPH⁴, William D. Chey, MD, FACG⁵, Jan Busby-Whitehead, MD⁶, Marie Gantz, PhD⁷, Heidi Chua, MD¹, Stacy Menees, MD⁸, William Perry, MBChB, MPH¹, Holly E.. Richter, PhD, MD⁹, Amaanti Sridhar, MSc⁷, Jennifer Wu, MD³, Lawrence Szarka, MD¹, Frank Hamilton, MD^10
1Mayo Clinic, Rochester, MN; ²Medical College of Georgia, Augusta University, Augusta, GA; ³University of North Carolina at Chapel Hill, Chapel Hill, NC; ⁴University of Alabama at Birmingham Heersink School of Medicine, Birmingham, AL; ⁵University of Michigan, Ann Arbor, MI; ⁶UNC School of Medicine, Chapel Hill, NC; ⁷RTI International, Research Triangle Park, NC; ⁸Michigan Medicine, Ann Arbor, MI; ⁹University of Alabama at Birmingham, Birmingham, AL; ¹⁰National Institutes of Health, Bethesda, MD

Introduction: Fecal incontinence (FI), affects 10% of community dwelling adults and markedly impairs quality of life. Among patients who fail medical and behavioral therapy, biofeedback (BIO) therapy and anal injection with dextranomer hyaluronate bulking agents (INJ), are recommended evidence-based treatments but have not been compared in a large multicenter randomized clinical trial.

Methods: Ambulatory patients aged ≥18 yrs with FI for ≥6 months, and ≥2 average weekly episodes of FI /week and fulfilled criteria for treatment with BIO/INJ were enrolled at 5 US centers (PMID: 34139357). Patients first received 4 weeks of enhanced medical management (EMM), which included dietary modifications and medications that were tailored to the underlying bowel disturbance(s), and pelvic floor exercises. Non-responders to EMM (i.e., < 75% reduction in average weekly FI episodes vs baseline) were randomized (1:1) to BIO (5-6 sessions) or INJ. The primary efficacy outcome was ≥75% reduction in average weekly FI episodes at 3 months vs baseline (intention to treat, ITT); primary safety outcome was proportion of patients with adverse events (AEs) of pelvic pain of grade II or higher severity, based on common terminology criteria for AEs, treatment site infection, or serious AEs (SAE) requiring hospitalization. Group outcomes were compared using adjusted logistic and general linear models, and for AEs, Fisher’s exact tests. Additional follow up to 24 months is in progress.

Results: 275 participants underwent EMM, 200 were randomized and included in ITT (101 INJ, 99 BIO). 183 initiated treatment (90 INJ, 93 BIO). There was no difference in 75% responder status, 28/101 (27.7%) vs 29/99 (29.3%), respectively, adjusted odds ratio, (95% confidence interval) 0.9 (0.5, 1.7), FI severity score, or FI quality of life scores (Table 1). Eleven AEs relevant to the primary safety outcome were reported in 7 participants (5 INJ, 2 BIO, p-value 0.27). Between randomization and 3-months, 5 participants had SAEs (3 INJ, 2 BIO), none related to the interventions.

Discussion: Biofeedback and dextranomer hyaluronate injection were not significantly different with respect to improvement in FI episodes and symptoms at 3 months in this first, large, multicenter clinical trial of patients with moderately severe FI who failed to respond to EMM. Both treatments should be considered in FI patients who have not adequately responded to conservative measures.


Disclosures:


Adil Bharucha, MBBS, MD¹, Satish S. C.. Rao, MD, PhD², William Whitehead, PhD³, Isuzu Meyer, MD, MSPH⁴, William D. Chey, MD, FACG⁵, Jan Busby-Whitehead, MD⁶, Marie Gantz, PhD⁷, Heidi Chua, MD¹, Stacy Menees, MD⁸, William Perry, MBChB, MPH¹, Holly E.. Richter, PhD, MD⁹, Amaanti Sridhar, MSc⁷, Jennifer Wu, MD³, Lawrence Szarka, MD¹, Frank Hamilton, MD¹⁰, 7, Comparative Effectiveness of Biofeedback and Dextranomer/Hyaluronate Injection for Treatment of Fecal Incontinence: A Multicenter Randomized Controlled Trial, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.