Postmarket Study PS130044/ Uphold LITE / U8090: A Prospective, Non-Randomized, Parallel Cohort, Multi-center Study of Uphold LITE vs. Native Tissue for the Treatment of Women with Anterior/Apical Pelvic Organ Prolapse
Sponsor: |
Boston Scientific Corporation |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAQ3901 |
U.S. Govt. ID: |
NCT01917968 |
Contact: |
Cara Grimes: 212-305-1107 / clg2173@cumc.columbia.edu |
The purpose of this research study is to compare the treatment device (Uphold LITE) to a traditional native tissue repair procedure for the treatment of symptoms for pelvic organ prolapse (POP). Uphold Lite is a non-absorbable synthetic mesh used to support tissue in women with POP. The device is inserted into the body through an incision in the vaginal wall. The device has been approved by the FDA and is currently used to treat POP. The purpose of this study is to look at how safe and how well this surgical mesh treats POP.
This study is closed
Investigator
Cara Grimes, MD, FACOG
Have you been diagnosed with pelvic organ prolapse? |
Yes |
No |