Satish Rao, MD, PhD: Biofeedback Versus Dextranomer Hyaluronate for Fecal Incontinence

New research is providing novel insight into the comparative effectiveness of biofeedback and anal injection with dextranomer hyaluronate bulking agents for the treatment of fecal incontinence.

Findings from the first-of-its-kind large multicenter randomized clinical trial were presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting in Philadelphia, Pennsylvania, and suggest both treatments should be considered for patients with fecal incontinence who have not adequately responded to conservative measures because they both had a similar impact on improvement of episodes and symptoms at 3 months.

“Fecal incontinence is a very common and really a devastating clinical problem,” Satish Rao, MD, PhD, J. Harold Harrison Distinguished University Chair in Gastroenterology and director of the Clinical Research Center at Augusta University, one of the study’s investigators, explained to HCPLive. “Once a patient has this, they become socially recluse, they are socially embarrassed. They don't function very well in society, and their life always revolves around where the restroom is located.”

Among patients who fail first-line medical and behavioral therapy, biofeedback therapy and anal injection with dextranomer hyaluronate bulking agents are the next recommended evidence-based treatments. However, the present study is the first to compare them in a large multicenter clinical trial.

“We've been engaged in really trying to improve the treatment options and the scientific evidence for these treatment options,” Rao said. “Never, ever has a comparative study been done, so when a patient presents, we don't know if we should just try conservative measures, biofeedback, or give them a dextranomer injection. That was the knowledge gap we were facing.”

Among 200 patients included in the intention-to-treat analysis, investigators did not observe any significant difference in the primary efficacy outcome, which was a ≥75% reduction in average weekly fecal incontinence episodes at 3 months versus baseline (27.7% for injection vs 29.3% for biofeedback; adjusted odds ratio, 0.9; 95% CI, 0.5-1.7). Additionally, no differences were observed in fecal incontinence severity or quality of life scores between the groups.

“We will be doing further research to look at the data more carefully to see if there are predictive factors to help us decide who is likely to respond to which treatment,” Rao said. “We are also interested in looking at which treatments led to improvement in which parameters, so these are all data that we hope to present in the future at coming meetings.”

Editors’ note: Rao has relevant disclosures with Ironwood Pharmaceuticals and Pallette Life Sciences.

Reference

^{Bharucha A, Rao SSC, Whitehead W, et al. 7 - Comparative Effectiveness of Biofeedback and Dextranomer/Hyaluronate Injection for Treatment of Fecal Incontinence: A Multicenter Randomized Controlled Trial. Paper presented at: ACG 2024 Annual Scientific Meeting. Philadelphia, Pennsylvania. October 25-30, 2024.}