Medical Devices: Evidence and Research (May 2016)
Management of fecal incontinence - focus on a vaginal insert for bowel control
Abstract
Eric R Sokol Department of Obstetrics and Gynecology, Stanford University School of Medicine, Stanford, CA, USA Abstract: Fecal incontinence, also referred to as accidental bowel leakage, is a debilitating condition that impacts quality of life in a significant number of women. Current treatments for fecal incontinence include behavioral modification, biofeedback, drug therapy, and invasive surgical procedures. However, these treatments have suboptimal efficacy due to patient adherence, variability of presentation across patients, cost, and additional health risks. A vaginal bowel control system (EclipseTM System) was developed to offer a low-risk, effective, and patient-managed approach to treating accidental bowel leakage. The vaginal bowel control system consists of a vaginal insert and user-controlled, pressure-regulated pump. Once inflated, the balloon of the vaginal insert is directed posteriorly to occlude the rectum, allowing the woman to immediately regain control of bowel function. This article will introduce the design evolution and feasibility studies of the Eclipse System. In addition, this review will discuss the results from a recent clinical trial that demonstrated the safety and efficacy of the vaginal bowel control system in managing fecal incontinence and other symptoms of bowel dysfunction. Keywords: accidental bowel leakage, fecal urgency, vaginal bowel control system, Eclipse System, bowel function