Vaginal Occluder Forestalls Fecal Incontinence in Women

A novel vaginal insert offers a noninvasive treatment option for fecal incontinence (FI) in adult women.

The Eclipse System is based an inflatable, removable, balloon which is placed in the vagina. Upon inflation, the balloon exerts pressure through the vaginal wall, occluding the rectal area, thereby reducing the number of FI episodes and protecting against unwanted stool passage. The device is initially fitted and inflated to the correct volume by a clinician using an external pump. After proper fitting has been completed, the patient can then inflate and deflate the device to the proper dimensions at home as needed.

The Eclipse System is a product of Pelvalon (Sunnyvale, CA, USA), and has been approved by the US Food and Drug Administration (FDA). The system, which is available in three base sizes and two balloon sizes, is intended to treat FI in women 18–75 years old who have had four or more FI episodes during a two-week period. The device should be removed periodically for cleaning.

“Our goal is to provide a front-line therapy that poses minimal risk but delivers superior bowel control,” said Miles Rosen, CEO of Pelvalon. “Today, women frequently don't report their symptoms. We hope our technology will encourage patients and physicians to start a new dialogue about bowel control.”

Fecal incontinence, also known as accidental bowel leakage (ABL), is the inability to control bowel movements and is a common problem, especially among older adults. FI particularly affects women who have experienced pregnancy, childbirth, or nerve or muscle damage in the pelvic region. As there are multiple causes for bowel control problems, effective treatment is particularly difficult and includes dietary modification, medical management, physical therapy, and often surgery or surgical implants. FI impacts women about twice as often as men.

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