A search for new options to manage fecal incontinence.

Fecal incontinence (FI) is a highly prevalent condition known to substantially impair a patient's quality of life. Although a non-invasive treatment option, currently available anal plugs are poorly tolerated, not significantly effective and therefore not often used. We present a new disposable device based on an innovative concept that renews the interest for non-invasive "external" control of bowel content for FI patients. The Contix™ (Forconti Medical Ltd, Cesarea, Israel) permits creation of temporary "artificial" fecal impaction to avoid bowel leakage while inserted high into the "non sensitive" rectum where it is not felt by the patient and therefore tolerated for 6- to 12- hour use. This European conformity (CE)-marked device has a unique design that allows insertion, usage and removal in a similar manner to a vaginal pad. It comes in 2 parts: a flexible silicone-based oval-shaped biocompatible balloon and an applicator in which the balloon is folded for self-insertion. An external tube allows for the balloon to be inflated with 60-100ml. of air. In doing this, small smooth tines deploy on its surface to help maintain the balloon in place. A pulling string with a ring stays out of the anal canal to deflate and withdraw the balloon inverted on itself at end of use. Device handling that includes rectal insertion and withdrawal feasibility, wear time, comfort at the different steps of use, safety and of course effectiveness of Contix™ have been tested in small trials yet to be published but pilot studies support its uses at greater scale in expert centers in Europe and the United States. In summary the Contix™ is a non-invasive device for FI management based on an innovative concept. Initial results support its spread to identify its role as an ancillary service to existing approaches.