The Rao Protocol for Anal Incontinence Improves Key Patient Reported Outcomes as Well as Objective Endurance on High Resolution Anorectal Manometry

Abstract

Introduction: In the United States, over 8% of adults are affected by anal incontinence (AI). When therapy mainstays such fiber supplements and anti-diarrheal medications fall short for patients, biofeedback (BFB) therapy is a key intervention, although a universal protocol has not been established. The Rao protocol for BFB is a physician-led program that consists of an active phase tailored to each patient, focusing on increasing sphincter tone and endurance, followed by refresher sessions. A solid state manometry catheter is utilized with sensors in the rectum and anal canal (instead of digital, EMG or ultrasoundbased approaches). Biofeedback is performed with a rectal balloon that can be inflated to simulate stool. Methods: This is a retrospective analysis of patients enrolled in BFB for AI between 2015 to 2018 at a tertiary referral motility program. For patients that had greater than two sessions, survey and high resolution anorectal manometry (HR-ARM) data were collected at baseline and during each AI BFB visit. 36 patients met criteria whose clinical characteristics are presented in table 1. Results: Self-reported mean global stool satisfaction on a scale of 1 (very dissatisfied) to 10 (very satisfied) showed a statistically significant increase from 3.6±2.6 at the start to 5.5±2.6 (p=0.0032) by the final visit. The mean number of AI accidents in one week was significantly reduced from 6±11 to 2±4 (p=0.0497). There were notable reductions in the number of patients using pads, stooling medications, and reporting urge AI symptoms by 20%, 32% and 19%, respectively. HR-ARM features were measured during each session and there was an improvement in endurance, defined as length of time able to maintain 50% of max squeeze pressure. With rectal balloon inflated to simulate stool, mean time (seconds) improved from 22 at session one to 24, and 29 by session three (p=0.0387). Contractile index, an integration of average squeeze over the first 10 seconds, was calculated for each BFB visit but did not show statistically significant change. Conclusion: Biofeedback with the Rao protocol in conjunction with use of HR-ARM catheters shows durable improvement in both meaningful clinical outcomes and objective endurance. The manometric data suggest gains in endurance may be predominantly responsible for the clinical benefits. We propose that the Rao protocol’s endurance training be given important consideration in BFB therapy for AI.425 Figure 1 No Caption available.