Pelvalon, Inc. is making its clinical debut at the 2014 AUGS/IUGA Scientific Meeting in Washington, D.C. with the presentation of results from LIFE, a pivotal study of the Pelvalon's Vaginal Bowel Control (VBC) System.
Holly E. Richter, Ph.D, M.D., Director of the Division of Urogynecology and Pelvic Reconstructive Surgery at the University of Alabama at Birmingham and immediate Past President of the Society for Gynecological Surgeons (SGS), served as the National Principal Investigator and will be presenting the results at 11:55am on Thursday, July 24, 2014.
The LIFE study followed 61 women who used the VBC system. At the 1-month primary endpoint, 79% of patients in the intent-to-treat cohort experienced treatment success (86% of patients in the per protocol cohort). Risks were demonstrated to be very low, with zero device-related serious adverse events observed. 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. "These results indicate that VBC may allow women to achieve a high degree of continence without risk of significant side effects and with an element of patient control," stated Dr. Richter. "This trial heralds a new era of treatment opportunity for women with bowel control problems."
Pelvalon’s VBC System is the first to restore bowel control using a device placed in the vagina. "Our goal is to provide a front-line therapy that poses minimal risk but delivers superior bowel control," said Pelvalon CEO Miles Rosen. "Today, women frequently don’t report their symptoms. We hope our technology will encourage patients and physicians to start a new dialogue about bowel control."
Over 20 million U.S. women suffer from loss of bowel control, also referred to as Fecal Incontinence (FI) or Accidental Bowel Leakage (ABL). FI particularly affects women who have experienced pregnancy, childbirth, or nerve or muscle damage in the pelvic region. 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.