Uphold LITE Post-Market Surveillance Study

Completed · Not applicable

Conditions studied: Pelvic Organ Prolapse

In brief

The purpose of this study is to compare transvaginal mesh repair to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.

Key facts

Study ID

NCT01917968

Run by

Boston Scientific Corporation

People needed

289

Starts

2013-10-10

Expected to finish

2020-02-12

Last updated by the study team

2021-05-20

Who can join

Age: 18 and older, up to 100. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subject is female
• Subject is ≥18 years of age
• Subject has pelvic organ prolapse with the leading edge at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba≥0 or (for prolapse of the anterior compartment alone) C≥0 (for prolapse of the apical compartment alone) or C≥-1/2 TVL and Ba≥0 (for a multi-compartment prolapse that includes the anterior and apical compartments).
• Subject reports of a bothersome bulge they can see or feel per PFDI-20, question 3 response of 2 or higher (i.e. responses of "somewhat", "moderately" or "quite a bit")
• Subject or subject's legally authorized representative must be willing to provide written informed consent
• Subject is willing and able to comply with the follow-up regimen

You may not qualify if…

• Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI) or tissue necrosis
• Subject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder, colo-rectal or cervical)
• Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area
• Subject has taken systemic steroids (within the last month) or immunosuppressive or immunomodulatory treatment (within the last 3 months)
• Subject has systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfans syndrome, Ehlers Danlos, collagenosis, polymyositis polymyalgia rheumatica)
• Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury, or stroke with residual neurologic deficit)
• Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)
• Subject has a previous prolapse repair with mesh in the target compartment
• Subject is planning to undergo a concomitant repair with use of mesh in the non-target compartment
• Subject is not able to conform to the modified dorsal lithotomy position
• Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that includes the pelvis
• Subject has uncontrolled diabetes mellitus (DM)
• Subject is currently participating in or plans to participate in another device or drug study during this study
• Subject has a known hypersensitivity to polypropylene mesh
• Subject is pregnant or intends to become pregnant during the study

Where it is running

• University of Alabama at Birmingham Kirklin Clinic — Birmingham, Alabama, United States
• Montgomery Women's Health Associates, PC — Montgomery, Alabama, United States
• UCSD Health/Women's Pelvic Medicine Center — La Jolla, California, United States
• Sherry Thomas, PC — North Hollywood, California, United States
• University of CA Irvine Medical Center — Orange, California, United States
• Kaiser Permanente OB/GYN Urogynecology — San Diego, California, United States
• Scripps Clinic Carmel Valley — San Diego, California, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• The Florida Bladder Institute — Naples, Florida, United States
• NorthShore University HealthSystem — Evanston, Illinois, United States
• Regional Urology, LLC — Shreveport, Louisiana, United States
• Capital Women's Care - Frederick — Frederick, Maryland, United States
• Las Vegas Minimally Invasive Surgery Women's Pelvic Health Center — Las Vegas, Nevada, United States
• Cooper University Hospital — Voorhees Township, New Jersey, United States
• Columbia University Irving Medical Center/NY Presbyterian Hospital — New York, New York, United States
• Presbyterian Hospital — Charlotte, North Carolina, United States
• Lyndhurst Clinical Research — Winston-Salem, North Carolina, United States
• St. Alexius Medical Center/Mid Dakota Clinic — Bismarck, North Dakota, United States
• University of Cincinnati Physicians Co — Cincinnati, Ohio, United States
• Institute for Female Pelvic Medicine & Reconstructive Surgery — Allentown, Pennsylvania, United States
• Institute for Female Pelvic Medicine & Reconstructive Surgery — North Wales, Pennsylvania, United States
• Prisma Health System — Greenville, South Carolina, United States
• Holston Medical Group at Seasons Center for Urogynecology & Advanced Pelvic Surgery — Bristol, Tennessee, United States
• Dr. M. Mitchell Silver, FACOG, PA — Nacogdoches, Texas, United States
• Kyle P. McMorries, MD — Nacogdoches, Texas, United States

Full record on ClinicalTrials.gov

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