A new intravaginal device recently approved by the Federal Drug Administration (FDA) and tested at UAB has been proven effective in improving fecal incontinence, a condition that affects more than 20 million women.
The Eclipse System, developed by California-based Pelvalon, Inc., is the first product to use a vaginal insert to control accidental bowel leakage. Restoring bowel control through the vagina is a new concept, and research results of the LIFE study are encouraging for women who suffer from this devastating condition. The results of the trial are described in the March 2015 edition of the journal, Obstetrics and Gynecology.
“The primary treatment for fecal incontinence is conservative behavioral and medical management composed of patient education, fiber supplements, medications to treat diarrhea, and behavioral techniques such as a scheduled toileting regimen and pelvic exercises. Surgical treatments also exist including sphincterplasty, bulking agents and neuromodulation with colostomy as a last resort,” says Holly E. Richter, PhD, MD, director of the Division of Urogynecology & Pelvic Reconstructive Surgery at UAB and past president of the Society for Gynecological Surgeons. She was the national principal investigator of the LIFE study trial. “The Eclipse intravaginal device can be used in conjunction with the mainstay conservative treatment approach and tried before surgical treatments are considered,” she adds.
The prevalence of fecal incontinence in women, young and old, is approximately four to 20 percent with greater occurrence among older women. “The most common causes are anatomic and neurologic injury,” Richter says. “The primary inciting event for most women is childbirth, however, there are other functional causes such as chronic diarrhea and fecal urgency that are treatable.”
The LIFE study followed 61 women at six U.S. sites, including UAB, who experienced four or more bowel incontinence accidents over two weeks and used the Eclipse System for one month with an option to continue to three months. Results showed that at one month, 86 percent of women who used the system saw improvement in bowel control. The success rate at three months was similar, suggesting that this effect is maintained. The women experienced a significant improvement in bowel incontinence episodes and quality of life without serious adverse events related to the device.
The device comes in various sizes and is initially fitted by a clinician. After proper fitting, the patient is taught to inflate and deflate the balloon in the device as needed. It works by exerting pressure on the rectum through the vaginal wall, just where a tampon typically is positioned, effectively closing off the rectum. When a trip to the bathroom is needed, the woman deflates the device then re-inflates it using an external pump that she carries with her. “Its effects are quality-of-life altering, and it is easy to use,” Richter says. “Women learn how to place and remove the device, how to pump it up and how to deflate it. It promises to be quality-of-life-changing for many.”
Pelvalon has not started marketing the device which was approved by the FDA in February. They are preparing for another study that will look at longer-term outcomes. Richter will again lead this multi-site study and UAB will again be a site for the new LIBERATE study. Research sites will begin enrolling participants in May 2015. Anyone interested in more information and/or in participating in the study can call (205) 934-3178.
“For this study, participants will first be fitted with a test device that will not be their permanent device. Just as with other vaginal devices, sometimes you have to change them out a time or two to get the right fit,” Richter says. “Once fit and the permanent device is provided, the primary outcome of the study will be at three months, and we will also look at outcomes as far out as a year. We are very excited about that.”
Richter is also happy about the possibility of being able to offer these patients a low-risk, nonsurgical treatment option for immediate bowel control. “This approach to therapy provides immediate effectiveness and allows patients to be proactive partners with their doctors in the management of a condition that keeps them from being active in family and social events,” she says.