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

1.2 Methods A 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.