Vaginal Insert Offers Alternative Treatment for Fecal Incontinence

A novel vaginal insert for bowel control eliminates the need for surgery or an in-office procedure for the treatment of female fecal incontinence (FI).

The second-generation Eclipse System is comprised of a vaginal insert in the form of an inflatable balloon that is placed in the same location as a tampon or a diaphragm. The insert is composed of a base portion, an inflatable balloon portion, an inflation tube, and a self-closing Luer valve connection. The base portion positions the balloon and helps maintain the placement of the insert in the vagina. The balloon itself is made of thin walled silicone, with an enclosed, non-body contacting polyurethane liner to minimize air loss. The silicone inflation tube terminates in the self-closing Luer valve that connects to the patient pump.

The pump itself is fitted with a removable regulating valve that controls the amount of air introduced to the inflatable balloon. During inflation, the pump is squeezed seven to ten times to adequately fill the balloon, with any excess air vented out by the regulator. When inflated, the balloon exerts pressure through the vaginal wall, occluding the rectal area and providing immediate bowel control. The patient can inflate and deflate the device at home when needed, thus reducing the number of FI episodes and protecting from unwanted stool passage. The device is removed periodically for cleaning.

The insert is initially fitted using a sizing tool to assist with customizing insert size, and is inflated to the correct volume by a clinician to determine the correct regulator valve. A trial insert is available to allow patients to evaluate the therapy before deciding whether it works for them. The system is available in three base sizes and two balloon sizes, and is intended for women 18–75 years old who have had four or more FI episodes during a two-week period. The Eclipse System is a product of Pelvalon (Sunnyvale, CA, USA), and has been approved by the US Food and Drug Administration (FDA).

“With this FDA clearance for our next-generation Eclipse, we are excited to initiate the first phase of our commercial launch in select centers of excellence,” said Miles Rosen, CEO and co-founder of Pelvalon. “We believe that this early phase of partnership with thought and practice leaders in the field of pelvic floor disorders will ensure a smooth expansion down the road.”

“Eclipse is a nonsurgical therapy offering immediate bowel control that can be used early in the treatment pathway,” said Holly Richter, MD, director of the division of urogynecology and pelvic reconstructive surgery at the University of Alabama (Birmingham, USA). “Like the first-generation device, the next-generation Eclipse is an easily tried approach that fills a gap between lifestyle changes in diet and exercise and more invasive treatments. I'm excited that this new option will soon be available to my patients.”

FI is the inability to control bowel movements and is a common problem, especially among older adults. It affects women about twice as often as men, most probably due to childbirth, nerve or muscle damage in the pelvic region, or gastrointestinal disorders such as irritable bowel syndrome (IBS). First-line treatments include dietary changes, exercise, and medication; if the issue persists, patients may need to move on to more invasive and costly treatments, such as surgery, surgical implants, or injections.

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