Biochemistry

   

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

Authors: Michelle Miki Takase-Sanchez

Background Accidental 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. 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. You can submit your Manuscripts at:  https://symbiosisonlinepublishing.com/submitManuscript.php 

Comments: 5 Pages.

Download: PDF

Submission history

[v1] 2017-08-26 02:33:03

Unique-IP document downloads: 2 times

Vixra.org is a pre-print repository rather than a journal. Articles hosted may not yet have been verified by peer-review and should be treated as preliminary. In particular, anything that appears to include financial or legal advice or proposed medical treatments should be treated with due caution. Vixra.org will not be responsible for any consequences of actions that result from any form of use of any documents on this website.

Add your own feedback and questions here:
You are equally welcome to be positive or negative about any paper but please be polite. If you are being critical you must mention at least one specific error, otherwise your comment will be deleted as unhelpful.

comments powered by Disqus