Effectiveness of Medical-Behavioral Therapy in Patients with Fecal Incontinence.

BACKGROUND AND AIMS: Guidelines recommend individualized medical and behavioral therapy (MBT) for fecal incontinence (FI), yet its effectiveness remains poorly defined. We assessed the response to MBT in FI. METHODS: In this 5-center U.S. trial, adults with FI received individualized MBT (dietary modifications, medications, and pelvic floor exercises) for up to 3 months. The primary outcome was a ≥75% reduction in FI frequency after 4 weeks of MBT. Secondary outcomes included 3-month FI, bowel habits, FI-related quality of life (QoL) and changes exceeding minimal clinically important differences (MCIDs). RESULTS: Among 260 participants, FI occurred approximately once daily on average, more than one-third of bowel movements were incontinent, and nearly 25% had undergone anorectal procedures and/or colon resection. Sixty (23%) participants responded at 1 month but only 39 (15%) had a sustained response at 3 months; 200 (77%) were non-responders. At 3 months, FI-QoL also improved in sustained responders (P≤.006). Greater reductions in FI frequency were associated with a higher likelihood of exceeding MCIDs for FI frequency (P<.006) and FI-QoL lifestyle and coping subscores (P≤.04). In multivariable analysis, a greater response was independently associated with higher baseline FI frequency and no external anal sphincter defects (P=.0002). For a given reduction in Bristol stool score, FI frequency declined more among participants with more frequent baseline FI (P=.002). CONCLUSION: Among patients with moderate-to-severe FI, 23% and 15% responded to MBT at 1 and 3 months. Responses at 3-months were clinically meaningful, associated with improved QoL, and more likely in patients with higher baseline FI frequency, and no visible external sphincter defects.