CONTACT: Emily Kumlien
(608) 265-8199
(608) 516-9154
ekumlien@uwhealth.org
Madison, WIS. – Physicians at the University of Wisconsin-Madison School of Medicine and Public Health are beginning to enroll participants in the LIBERATE Study, a national, multi-center clinical trial evaluating the long-term safety and effectiveness of an updated device for the treatment of fecal incontinence. Dr. Heidi Brown, assistant professor of obstetrics and gynecology and urology at UW-Madison, is the principal investigator for UW-Madison, which is one of 14 sites around the nation.
More than 20 million U.S. women suffer from loss of bowel control, sometimes referred to as fecal incontinence (FI) or accidental bowel leakage (ABL). Many women of all ages restrict their daily activities because of the embarrassing stigma around the condition and the perceived lack of treatment options. Fewer than one in three women with ABL report asking a physician about their symptoms.
ABL is more common in older adults, those with diabetes, and those with bowel disorders such as chronic diarrhea, constipation, or irritable bowel syndrome (IBS). It can sometimes follow a history of damage to the pelvic floor from obstetric injury or pelvic surgery or radiation or functional problems such as diarrhea or irritable bowel syndrome (IBS). Current treatments include dietary modification, medications, biofeedback and physical therapy, office procedures, and surgery.
“Pelvic-floor disorders are common, but they are not normal and are not an inevitable part of getting older or of having children. I’m dedicated to raising awareness and finding solutions for this often stigmatized disease,” said Brown. “A study published in the Journal of the American Medical Association (JAMA) last week reports that almost half of US adults have diabetes or pre-diabetes, which is another risk factor for ABL. I want those people who may be suffering in silence to know that good solutions are available, and asking a doctor about these solutions is the first step to getting help.”
The LIBERATE Study is investigating the Eclipse System, a 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 by the patient at any time. A hand-held pump is used to inflate and deflate a balloon on the insert. The balloon is designed to occlude the rectum to protect against unwanted stool passage. The insert is non-surgical and does not contain drugs or hormones.
The 12-month active study period for the LIBERATE study is longer than an earlier study, LIFE, which followed women for one to three months of using an earlier generation of the system. The long-term safety and efficacy of the LIBERATE device has not yet been proven.
UW-Madison School of Medicine and Public Health was selected as one of 14 centers in the United States participating in the trial, which is expected to enroll 150 patients.
About Pelvalon
The Eclipse System is designed and manufactured by Pelvalon, a privately-held company founded in 2010. Pelvalon’s technology originated from Stanford University’s Biodesign program, a collaboration between the schools of medicine and engineering.
The version of the Eclipse System being studied in LIBERATE is limited by federal law to investigational use only, meaning its safety and effectiveness is, as yet, unproven, and is not available for sale. An earlier version of the system, evaluated in the LIFE study, was granted marketing authorization by the U.S. Food and Drug Administration (FDA), but has not been commercially released.
