It is a condition that is so embarrassing that most women never broach the subject with their physicians. Yet more than 20 million women in the U.S. suffer from loss of bowel control, sometimes referred to as Fecal Incontinence (FI) or Accidental Bowel Leakage (ABL).
Crystal was one of them. Then she joined a study in March 2016 at the UNM Health Center that uses a drug-free, non-invasive device designed to give patients the freedom to go about their daily lives without worries of suddenly soiling their clothes.
“It has been life changing,” she said.
UNM was selected as one of only 11 centers in the United States participating in the clinical trial called the LIBERATE Study. Participants use a vaginal insert designed to provide immediate bowel control. Called the Eclipse System, the device is a small inflatable balloon and was designed to offer women a non-surgical, non-pharmaceutical treatment option.
The device is placed in the same location as a tampon or a diaphragm, can be removed at any time and contains no hormones or drugs. Once inflated with a hand-held pump, the insert is designed to occlude the rectum and protect against unwanted stool passage.
"Before I used this, I was so humiliated," Crystal said. "To leave the house meant packing as if I was carrying a baby – wipes, undies – I never had any warning if something was about to happen.”
Crystal asked that her real name not be used. She is far from alone. The condition is so embarrassing that only 29 percent of women will even raise the subject with their physicians.
Doctors know there are multiple causes for FI -- it is often attributable to a history of obstetric damage to the pelvic floor, or functional problems such as diarrhea or Irritable Bowel Syndrome (IBS). But while causes are many, treatment options are few, said Gena Dunivan, MD, a urogynecologist and the principal investigator at UNM.
Add to the fact that while the condition can have many causes and before now, there have been few effective options except for surgery, which is accompanied by risks and side effects.
That was the case with Crystal. While her doctors said they believed the loss of control was from muscle weakness, they could not identify the triggering cause.
"It came on gradually," she said. "It was a couple of years before I mentioned it to anyone. But the more it happened, the more reluctant I became to even leave the house."
When her physician recommended she see a surgeon Crystal knew she didn’t want that. "Then I heard about this,” she said of the device. She liked that it was not invasive and maintenance was easy. "I don’t know what I would do without it," she said.
"I know there are other people out there who are suffering from this condition and like me, they are too embarrassed to talk about it. This device has really given me back my freedom.”
In a clinical trial of women who used the insert for one month, Eclipse was effective in 86 percent of those successfully fitted with the insert. The most common adverse event was discomfort, most frequently associated with the fitting process and typically resolved by just removing the insert. At the end of the study, 96 percent of participants successfully fitted with the insert found the Eclipse to be comfortable, and 98 percent reported that that they would recommend it to a friend.
UNM has now become one of only six hospitals nationwide currently offering the Eclipse System to patients suffering accidental bowel leakage on a commercial basis. Interested patients should contact the UNM Urogynecology Clinic at (505) 272-9474.
About University of New Mexico Health Sciences Center The University of New Mexico Health Sciences Center is the only academic center in the state of New Mexico. UNM’s Urogynecology Division has a long history of conducting successful clinical and translational research focused on determining the etiology of and best treatments for pelvic floor dysfunction and is committed to serving and improving the health of women in New Mexico.