Designers: Vlada Belezerova, Eclipse System Team, Design Concepts, Inc., Madison, Wisconsin, USA
Manufacturer: Pelvalon, Inc., Sunnyvale, California, USA
For many women with Accidental Bowel Leakage (ABL), the loss of bowel control becomes the controlling force in their lives. Fearing an embarrassing accident, many choose to stay close to home and miss out on the activities they love.
ABL is a multifactorial condition with a highly variable etiology, making the design of a solution difficult. The first line of therapy typically involves modification of diet, exercise and guided use of a stimulator and probes to try to retrain sphincter muscles. Rectal plugs provide some control but are unpopular with patients because they are uncomfortable and increase the urge to defecate. The next level of intervention is surgical and includes an implantable neuromodulation therapy. Even the most invasive surgical treatments have long-term failure rates between 30-50 percent.
Pelvalon, a Bay Area startup, identified an unmet need for an effective, non-surgical solution. Its Eclipse System offers an option between lifestyle modification and surgery that is immediately effective in controlling ABL for 86 percent of women who are successfully fitted for an insert. No additional exercises or therapy are necessary.
It is the first vaginal insert designed to provide bowel control. The insert is placed in the same location as a tampon or a diaphragm, and can be removed at any time. The insert is fitted during an office visit. A well-fit insert will be comfortable for almost all women. Women who were successfully fit with Eclipse in a one-month study overwhelmingly reported comfort wearing the insert.
A detachable and discreet handheld pump is used to inflate and deflate a balloon on the insert. The balloon is designed to control the rectum and prevent stool from passing unexpectedly. When the user is ready to have a bowel movement, she simply deflates the balloon. Once she has finished her bowel movement, she can inflate the balloon again and go on her way. This design allows her to actively control her bowels.
