166
Participants
Start Date
February 9, 2018
Primary Completion Date
March 9, 2020
Study Completion Date
March 9, 2020
ES-130
"The ES-130 device will be used for the indication of Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device."
Magee-Women's Hospital, Department of Obstetrics and Gynecology, Pittsburgh
University of Pennsylvania, Philadelphia
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery, Durham
University of Texas Southwestern Medical Center, Dallas
Kaiser Permanente -- Downey, Downey
Kaiser Permanente -- San Diego, San Diego
University of Alabama at Birmingham, Birmingham
University of California at San Diego, UCSD Women's Pelvic Medicine Center, La Jolla
Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery, Providence
Collaborators (1)
University of Alabama at Birmingham
OTHER
University of California, San Diego
OTHER
Duke University
OTHER
Women and Infants Hospital of Rhode Island
OTHER
RTI International
OTHER
University of Pennsylvania
OTHER
University of Pittsburgh
OTHER
Kaiser Permanente
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Texas Southwestern Medical Center
OTHER
NICHD Pelvic Floor Disorders Network
NETWORK