Study confirms effectiveness of device to improve bowel control
Research led by the University of Alabama at Birmingham Division of Urogynecology and Pelvic Reconstructive Surgery shows a vaginal bowel-control system designed by Pelvalon is the first device to successfully control fecal incontinence, also known as accidental bowel leakage, via a vaginal insert. The results of the research, known as the LIFE study, are available now online and will be published in the March 2015 issue of Obstetrics & Gynecology.
The LIFE study followed 61 women at six U.S. sites who experienced accidents twice or more per week and used the Eclipse System for one month. The study results, previously reported at the 2014 American Urogynecologic Society and the International Urogynecological Association Scientific Meeting, showed that at one month, 86 percent of women who used Eclipse experienced treatment success. Also, no device-related serious adverse events were observed, and women experienced a significant improvement in quality of life. In fact, 98 percent of trial participants said they would recommend it to a friend.
"The LIFE study results indicate that Eclipse will offer an important new therapeutic option for women with accidental bowel leakage," said Holly E. Richter, Ph.D., M.D., director of the Division of Urogynecology and Pelvic Reconstructive Surgery at UAB and immediate past president of the Society for Gynecological Surgeons.
Richter is the national principal investigator of the LIFE trial and lead author on the paper. "I hope that the publication will help raise awareness among clinicians about the prevalence of this condition and a new potential solution."
More than 20 million U.S. women suffer from loss of bowel control. Women who have experienced pregnancy, childbirth, or nerve or muscle damage in the pelvic region are at particular risk for bowel-control problems.
Many women suffer in silence, Richter says, fearing accidents and restricting their daily activities because of the embarrassing stigma around the condition and the lack of successful, noninvasive treatments.
"This approach to therapy typically provides immediate effectiveness and allows the patient to be a proactive partner with the provider in the management of a condition that often keeps them being active in family and societal events," Richter said.
Restoring bowel control through the vagina is a new concept. The Eclipse System includes a vaginal insert, which is placed in the same location as a tampon, and a special pump for inflating and deflating a balloon on the insert. The balloon is designed to occlude the rectum to protect against unwanted stool passage. Women can remove the insert at any time.
The Eclipse System is intended to offer women a noninvasive and nonsurgical treatment option. The system is limited by federal law to investigational use only at this time and is not yet available for sale.
Miles Rosen, chief executive officer of Pelvalon, says acceptance of these study results by a prestigious peer-reviewed journal is an important milestone for Pelvalon and the Eclipse System.
"We are looking forward to the opportunity to bring this therapy to the market and serve the millions of women suffering from loss of bowel control," Rosen said.