480
Participants
Start Date
October 28, 2013
Primary Completion Date
August 9, 2017
Study Completion Date
September 29, 2017
Miduretheral Sling
MUS can include the TVT™ (mechanical cut mesh only, Gynecare, ETHICON Women's Health \& Urology, Somerville, NJ), TVT-O™ (mechanical cut mesh only, Gynecare), or Monarc™ (American Medical Systems, Minnetonka, MN).
Miduretheral Sling with behavioral/pelvic floor therapy
MUS is combined with components of behavioral therapy (designed to change behaviors to encourage continence), and pelvic floor muscle therapy (designed to strengthen the pelvic floor muscles, enhance the physiological closure of the bladder neck, and improve coordination). This is done prior to MUS (1 visit) and after MUS for 5 visits at 2, 4, 6, 8 weeks and 6 months.
Magee-Womens Hospital, Department of Obstetrics and Gynecology, Pittsburgh
University of Pennsylvania, Philadelphia
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery, Durham
Cleveland Clinic, Department OB/GYN, Cleveland
Kaiser Permanente -- Downey, Downey
Kaiser Permanente -- San Diego, San Diego
University of Alabama at Birmingham, Department of Obstetrics and Gynecology, Birmingham
University of California at San Diego, UCSD Women's Pelvic Medicine Center, La Jolla
University of New Mexico Health Sciences Center, Department of Obstetrics and Gynecology, Albuquerque
Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery, Providence
Collaborators (1)
Women and Infants Hospital of Rhode Island
OTHER
The Cleveland Clinic
OTHER
Duke University
OTHER
University of Alabama at Birmingham
OTHER
University of New Mexico
OTHER
University of Pennsylvania
OTHER
University of Pittsburgh
OTHER
University of California, San Diego
OTHER
Kaiser Permanente
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
RTI International
OTHER
NICHD Pelvic Floor Disorders Network
NETWORK