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.