A Staged Feasibility Study of a Novel Vaginal Bowel Control System for the Treatment of Accidental Bowel Leakage in Adult Women

Abstract

BackgroundAccidental bowel leakage, or fecal incontinence, impacts the quality of life in women of all ages. A minimallyinvasive vaginal bowel control system was designed to reduce accidents and provides a new health care option for women. MethodsA feasibility study was conducted to evaluate fit, patient comfort, and ease-of-use of this novel vaginal bowel control therapy at home to better inform device design, treatment delivery, and the design of a subsequent pivotal clinical trial protocol. Staged evaluations were performed in women without and with self-reported accidental bowel leakage of any severity. Wear duration progressed from an initial one-time, in-office fitting to extended-wear periods at home. Device-related adverse events were collected in all subjects exposed to the device. Treatment responses were collected at baseline and after 1-month wear in women with accidental bowel leakage. Additionally, device comfort and satisfaction were assessed. ResultsEighty-six women were fitted with forty-five women continuing to wear the vaginal bowel control system for ≥ 1 week. Fifteen women with fecal incontinence were extended to ≥ 1-month wear. Nine minor devicerelated adverse events were reported. Eight of 9 women who completed diaries experienced ≥ 50% reduction in episodes at 1-month wear. Device comfort and satisfaction were high.