UNC Urogynecology recruiting for LIBERATE study

Are you a woman experiencing loss of bowel control? The LIBERATE Study may be right for you.


Accidental Bowel Leakage (ABL) or Fecal Incontinence (FI) isn't often talked about due to its embarrassing nature, but there are 20 million American women of all ages with this condition. Accidental loss of stool is sometimes associated with an intense urge to rush to the bathroom. It can also happen with no warning. This condition particularly affects women who have experienced obstetric trauma from childbirth, or other nerve or muscle damage in the pelvic region. Many women suffer in silence, fearing accidents and restricting their daily activities, not realizing that treatments exist which may help restore bowel control.

LIBERATE is a research study for women experiencing bowel control problems. The study is evaluating the investigational Eclipse System, designed to provide immediate bowel control. The Eclipse System includes a vaginal insert and a hand-held pump for inflating and deflating a balloon on the insert. The insert is placed in the vagina, resting in the same place as a diaphragm or tampon. The insert is non-surgical and does not contain drugs or hormones. The Eclipse is designed to control the rectum from within the vagina in order to prevent accidental stool passage when the balloon is inflated. It may be removed at any time.

The LIBERATE study involves longer-term follow-up than an earlier study, called LIFE, which followed women for 1-3 months of using the previous version of the Eclipse System. The LIFE study found that most women experienced a reduction in accidents without major side effects and adverse events were mild or moderate, and none required any significant intervention. The version of the Eclipse System used in the LIFE study was cleared by the U.S. Food and Drug Administration (FDA), but has not been commercially released by the company. The LIBERATE study is evaluating the next generation of Eclipse.

LIBERATE study participation may last approximately 15 months. Some reimbursement is provided to study participants.

Eligibility
Inclusion Criteria:
• Female
• At least 19 years old
• History of accidental bowel leakage for at least 6 months

Principal Investigator
Dr. Jennifer Wu
Urogynecology and Reconstructive Pelvic Surgery at UNC-Chapel Hill

For information contact:
Liberate Research Team
3032 Old Clinic Bldg. CB# 7570
Chapel Hill, NC 27599
Phone: 919-843-8259

IRB approval 5/27/2015, Bio-medical, #15-0026, LIBERATE: A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women

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