SUNNYVALE, Calif., Oct. 23, 2014 /PRNewswire/ — Pelvalon released additional results from the LIFE trial, a pivotal study of the previously-unnamed Eclipse System, a vaginal insert designed to provide bowel control. This new analysis considered the fitting process and offered expanded data on the treatment effect. Catherine Matthews, MD, Associate Professor and Division Chief of Urogynecology and Reconstructive Pelvic Surgery at the University of North Carolina, will present the results on Thursday, October 23, 2014 at the International Continence Society 2014 Annual Meeting in Rio de Janeiro, Brazil.
The LIFE study followed 61 women who experienced accidental bowel leakage twice or more per week and used the Eclipse System (consisting of an insert and a pump) for one month. The Eclipse Insert, which is offered in a range of sizes, requires fitting by a physician familiar with pelvic anatomy. Not all women were successfully fit in the LIFE study. This analysis showed that three aspects of vaginal anatomy, previous prolapse surgery, shorter vaginal length, and vaginal atrophy, were associated with unsuccessful fitting in some, but not all, women.
Once successfully fit, the treatment effect was also further analyzed. Women can experience incontinence in many forms, including different types of stool consistency, size and urgency. Women who used the Eclipse System experienced a significant reduction in all types of episodes: solid and liquid, major and minor, and episodes with and without a sense of urgency.
“These results continue to support the great potential of vaginal bowel control therapy,” said Dr. Matthews. “Given the low-risk nature of the therapy and the sparse options for current treatment of fecal incontinence, we will likely attempt to fit an Eclipse Insert even in challenging anatomy, once the device becomes commercially available. However these predictors will help us to counsel and set expectations with patients.”
Miles Rosen, CEO of Pelvalon, commented, “We are encouraged by the positive clinical trial results across the spectrum of incontinence episodes, especially episodes with urgency which are particularly bothersome to patients. We are also pleased to have a more developed understanding of the fitting process, and we are already working to develop new device sizes and designs to fit a higher percentage of patients in the future.”
The LIFE study was originally presented at the 2014 AUGS/IUGA Scientific Meeting by Holly E. Richter, Ph.D, M.D., Director of the Division of Urogynecology and Pelvic Reconstructive Surgery at the University of Alabama at Birmingham. At the 1-month primary endpoint, 79% of women in the intent-to-treat cohort and 86% of the per protocol cohort experienced treatment success, and zero device-related serious adverse events were reported. Additionally, 96% of the women who completed the trial found the insert to be comfortable, and 98% said they would recommend it to a friend.
Over 20 million U.S. women suffer from loss of bowel control, also referred to as Fecal Incontinence (FI) or Accidental Bowel Leakage (ABL). 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, fearing accidents and restricting their daily activities, because of the embarrassing stigma around the condition and the lack of successful, non-invasive treatments.
About Vaginal Bowel (VBC) Control and the Eclipse System
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. The user inflates a balloon on the insert, which is designed to occlude the rectum to protect against unwanted stool passage. The balloon is deflated for bowel movements. Women can remove the insert at any time. The Eclipse System is intended to offer women a non-invasive and non-surgical treatment option.
The Eclipse System is an investigational device. It is limited by U.S. law to investigational use. It is not currently available for sale.
Headquartered in Sunnyvale, California, privately held Pelvalon aims to improve the lives of women who suffer from bowel control problems. Founded in 2010, Pelvalon’s groundbreaking technology originated from Stanford University’s Biodesign program, a collaboration between the schools of medicine and engineering. Pelvalon’s investors include Norwich Ventures, a specialized venture capital firm focused on medtech.