150
Participants
Start Date
June 8, 2020
Primary Completion Date
February 12, 2024
Study Completion Date
February 12, 2024
Botox® injection
Botulinum toxin A will be prepared by dissolving 100 units of botulinum toxin A into 10 ml of injectable saline. Indigo carmine or methylene blue 0.1 ml will be added to each syringe of botulinum toxin A. The treating physician will inject a total of 10 ml of the Botox A® into approximately 15 to 20 different detrusor muscle sites under direct visualization.
Mid-urethral sling
"Mid-urethral Sling Procedure includes retropubic as well as transobturator full length slings. Mini-sling and single-incision sling will not be allowed due to potential risk for higher failure rate."
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 Alabama at Birmingham, Department of Obstetrics and Gynecology, Birmingham
University of Texas Southwestern Medical Center, Dallas
Kaiser Permanente, San Diego
University of California at San Diego, La Jolla
Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery, Providence
Collaborators (1)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Women and Infants Hospital of Rhode Island
OTHER
Duke University
OTHER
University of Pennsylvania
OTHER
University of Pittsburgh
OTHER
University of California, San Diego
OTHER
Kaiser Permanente
OTHER
University of Texas Southwestern Medical Center
OTHER
University of Alabama at Birmingham
OTHER
RTI International
OTHER
NICHD Pelvic Floor Disorders Network
NETWORK