Dr. Dena O’Leary

New OU study evaluates a non-surgical treatment for fecal incontinence

It’s a topic few want to talk about even with their physicians – loss of bowel control. Yet it affects more than 20 million women in this country. Now, a new device under study at the University of Oklahoma Health Sciences Center may offer relief without surgery.
“This is the first time this option has been available,” said Dr. Dena O’Leary of the study. O’Leary, a urogynecologist with OU Physicians, is principal investigator of the LIBERATE Study at OU.
The national, multi-center clinical trial is evaluating the long-term safety and effectiveness of a non-invasive device that targets loss of bowel control, also known as fecal incontinence or accidental bowel leakage.
The device is inserted in the same location as a tampon or a diaphragm and can be removed at any time. A hand-held pump is used to inflate and deflate a balloon on the insert. When inflated, the device is designed to occlude the rectum to protect against unwanted stool passage.
“What makes this device unique is it is designed specifically for fecal incontinence. It really fills a need between treatments such as stool bulking agents and surgery,” O’Leary explained.
The insert does not contain drugs or hormones, and is intended to offer women a non-surgical treatment option.
“This is an important study evaluating the long-term safety and effectiveness of a device that provides women with a new option. That’s huge because even our best surgeries have a long-term success rate of only 40 or 50 percent,” O’Leary said.
The new study aims to enroll 120 women nationwide and will follow them for 12 months. An earlier study of a predecessor of the current device followed women for only one to three months, but brought promising results. Most women in that study experienced a reduction in accidents and without major side effects.
O’Leary explained there are multiple causes for fecal incontinence. It is often related to a history of obstetric damage to the pelvic floor or to functional problems such as diarrhea or Irritable Bowel Syndrome. Many women of all ages suffer in silence, fearing accidents and restricting their daily activities. Fewer than one in three women with fecal incontinence tell their doctors about it.
“It’s important to remember that you are not alone. This problem is relatively common and often treatable. So it is very important that women talk to their doctor about it,” O’Leary said. “If you are comfortable, talk to your primary care physician first.”
While the study device may provide an important new option for women, there are also other non-surgical options currently available to women. Current treatments include physical therapy, dietary modification, medications and biofeedback as well as surgery.
“In our clinic, we tend to begin with the most conservative approaches and tailor the treatment to each patient’s specific needs,” O’Leary explained. “We also have specially trained physical therapists who can help women with exercises that address specific pelvic floor issues that may contribute to fecal incontinence.”
To learn more about the female pelvic health clinic at OU Physicians, visit www.oumedicine.com