Xenform Postmarket Surveillance Study

Completed · Not applicable

Conditions studied: Pelvic Organ Prolapse

In brief

To compare transvaginal repair with a biologic graft to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.

Key facts

Study ID

NCT01945580

Run by

Boston Scientific Corporation

People needed

374

Starts

2014-02-10

Expected to finish

2020-02-12

Last updated by the study team

2021-04-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subject is female
• Subject is at least 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 (for prolapse of the anterior compartment alone) or 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 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 is willing to provide written informed consent
• Subject is willing and able to comply with the follow-up regimen

You may not qualify if…

• Subject is pregnant or intends to become pregnant during the study
• 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), Marfan syndrome, Ehlers Danlos, collagenosis, polymyositis, polymyalgia rheumatica)
• Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
• Subject has uncontrolled diabetes mellitus (DM)
• 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 is not able to conform to the modified dorsal lithotomy position
• Subject is currently participating in or plans to participate in another device or drug study during this study
• Subject has a known sensitivity to any Xenform component
• Subject has had previous prolapse repair with mesh in the target compartment
• Subject is planning to undergo a concomitant prolapse repair with use of mesh in the non-target compartment

Where it is running

• University of California, Irvine Medical Center — Orange, California, United States
• Emory Hospital — Atlanta, Georgia, United States
• Augusta University — Augusta, Georgia, United States
• Cherokee Womens Health Specialist — Canton, Georgia, United States
• NorthShore University Health System — Skokie, Illinois, United States
• Acadia Women's Health — Crowley, Louisiana, United States
• Chesapeake Urology Research Associates — Hanover, Maryland, United States
• Chesapeake Urology Research Associates — Owings Mills, Maryland, United States
• Mount Auburn Hospital — Cambridge, Massachusetts, United States
• Beyer Research — Kalamazoo, Michigan, United States
• Cooper University Hospital — Voorhees Township, New Jersey, United States
• University of Buffalo — Buffalo, New York, United States
• Beth Israel Medical Center — New York, New York, United States
• NYU Langone Medical Center — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Carolina Urology Partners — Gastonia, North Carolina, United States
• Lyndhurst Clinical Research — Winston-Salem, North Carolina, United States
• Prime Care of SEO — Dresden, Ohio, United States
• Prisma Health System — Greenville, South Carolina, United States
• Southern Urogynecology — West Columbia, South Carolina, United States
• Center for Pelvic Health — Franklin, Tennessee, United States
• Practice Research Organization — Dallas, Texas, United States
• Houston Metro Urology — Houston, Texas, United States
• Las Colinas ObGyn — Irving, Texas, United States
• MultiCare Women's Health Care — Covington, Washington, United States

Full record on ClinicalTrials.gov

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