Restorelle® Mesh Versus Native Tissue Repair for Prolapse



Status:Active, not recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - Any
Updated:9/21/2018
Start Date:August 2014
End Date:November 2021

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Trial Summary
Trial Overview
Inclusion Criteria

Restorelle® Transvaginal Mesh Versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse, Restorelle 522 Study

The purpose of this study is to collect information on the safety and effectiveness of
Restorelle Direct Fix mesh and the surgical procedure to implant Restorelle. These results
will be compared to the safety and effectiveness results in patients who have native tissue
repair (without mesh) as their pelvic organ prolapse treatment.


Inclusion Criteria:

- Female at least 18 years of age

- Subject has pelvic organ prolapse with leading edge at or beyond the hymen. At or
beyond the hymen is defined as POP-Q scores of Ba ≥0 and C≥ -1/2 tvl or Bp ≥0 and C≥
-1/2 tvl

- 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 is willing to provide written informed consent

- Subject is willing and able to comply with the follow-up regimen

Exclusion Criteria:

- 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 a history of pelvic organ cancer (e.g. uterine, ovarian, bladder, 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 a systemic connective tissue disease (e.g. scleroderma, systemic lupus
erythematosus (SLE), Marfan syndrome, Ehlers Danlos, collagenosis, polymyositis or
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 polypropylene

- Subject has had previous prolapse repair with mesh in the target compartment(s)

- Subject is planning to undergo a concomitant prolapse repair in a non-target
compartment with anything other than native tissue repair
We found this trial at
34
sites
Rosemark Women Care Specialists
Idaho Falls, Idaho 83404
Principal Investigator: Jason Gundersen, MD
Phone: 208-557-2982
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Idaho Falls, ID
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Sherry Thomas, M.D.
Agoura Hills, California 91301
Principal Investigator: Sherry Thomas, MD, MPH
Phone: 818-991-0988
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Agoura Hills, CA
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Akron Urogynecology Associates
Akron, Ohio 44313
Principal Investigator: Costas Apostolis, MD
Phone: 330-344-7681
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from
Akron, OH
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Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania 18105
Principal Investigator: Vincent Lucente, MD, MBA
Phone: 610-435-9575
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mi
from
Allentown, PA
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Central Texas Urogynecology and Continence Center
Austin, Texas 78758
Principal Investigator: Tomas Antonini, MD
Phone: 512-716-0861
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Austin, TX
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Montefiore Medical Research Center
Bronx, New York 10461
Principal Investigator: Keith Downing, MD
Phone: 718-405-8200
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Bronx, NY
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Cooper University Hospital
1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Principal Investigator: Holzberg Adam, DO, FACOG
Phone: 856-968-7547
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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Camden, NJ
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Novant Health Urogynecology
Charlotte, North Carolina 28210
Principal Investigator: William Porter, MD
Phone: 704-574-5157
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from
Charlotte, NC
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Carilion Clinic New River Valley
Christiansburg, Virginia 24073
Principal Investigator: Tamera Howell, MD
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Christiansburg, VA
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Good Samaritan Hospital
Cincinnati, Ohio 45220
Principal Investigator: Steven Kleeman, MD, FACOG
Phone: 513-463-4308
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Cincinnati, OH
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MetroHealth Med Ctr
2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
Principal Investigator: Jeffrey Mangel, MD
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Cleveland, OH
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Scott D. Lauer, DO, PA
Colleyville, Texas 76034
Principal Investigator: Scott D Lauer, DO
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Colleyville, TX
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SurgOne Pelvic Solutions Center
Denver, Colorado 80218
Principal Investigator: James Lukban, DO
Phone: 720-205-4537
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Denver, CO
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Female Pelvic Medicine & Urogynecology Institute of MI
Grand Rapids, Michigan 49503
Principal Investigator: Douglas Van Drie, MD
Phone: 616-588-1800
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Grand Rapids, MI
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Women's Pelvic Health and Continence Center
Hamlet, North Carolina 28345
Principal Investigator: Janet Harris-Hicks, MD
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Hamlet, NC
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Beyer Research
Kalamazoo, Michigan 49009
Principal Investigator: Roger Beyer, MD
Phone: 269-372-7800
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Kalamazoo, MI
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Center for Women's Health of Lansdale
Lansdale, Pennsylvania 19446
Principal Investigator: Donald DeBrakeleer, DO
Phone: 215-368-1950
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Lansdale, PA
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Atlantic Health System
Morristown, New Jersey 07960
Principal Investigator: Charbel Salamon, MD, MS
Phone: 973-971-7267
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Morristown, NJ
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Integrity Medical Research
Mountlake Terrace, Washington 98043
Principal Investigator: Karny Jacoby, MD, CPI
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Mountlake Terrace, WA
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Swan Urogynecology
Nashville, Tennessee 37203
Principal Investigator: Michael C. Swan, MD, MBA
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Nashville, TN
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Yale University School of Medicine
333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Richard Bercik, MD
Phone: 203-785-2164
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New Haven, CT
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Center for Urogynecology and Pelvic Surgery, Christiana Care Health System
Newark, Delaware 19713
Principal Investigator: Babak Vakili, MD, FACOG
Phone: 302-733-3056
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Newark, DE
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The Female Pelvic Health Center
Newtown, Pennsylvania 18940
Principal Investigator: Stephanie Molden, MD
Phone: 215-504-8900
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Newtown, PA
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The Group for Women
Norfolk, Virginia 23502
Principal Investigator: Mohamed-Mehdi Parva, MD
Phone: 757-471-3375
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Norfolk, VA
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Adult and Pediatric Urology P.C
Omaha, Nebraska 68114
Principal Investigator: Rebecca McCrery, MD
Phone: 402-399-7892
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Omaha, NE
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Andrew Shapiro
Owings Mills, Maryland 21117
Principal Investigator: Andrew M Shapiro, MD
Phone: 443-471-5873
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Owings Mills, MD
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Premier Medical Group of the Hudson Valley
243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
Principal Investigator: Daniel M. Katz, MD
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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Poughkeepsie, NY
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Sanford Research
Sioux Falls, South Dakota 65104
Principal Investigator: Kevin Benson, MD, MS
Phone: 605-328-1389
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Sioux Falls, SD
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Baystate Health System
Springfield, Massachusetts 01199
Principal Investigator: Keisha Jones, MD
Phone: 413-794-7045
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Springfield, MA
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Centre for Advanced Reproductive Endosurgery
69 Christie Street
St Leonards, New South Wales 2065
Principal Investigator: Alan Lam, MD
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St Leonards,
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Stanford University
450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Eric R Sokol, MD
Phone: 650-724-7826
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Stanford, CA
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MedStar Washington Hospital Center, National Center for Advanced Pelvic Surgery
Washington, District of Columbia 20010
Principal Investigator: Andrew Sokol, MD
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Washington,
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Novant Health Clinical Research
Winston-Salem, North Carolina 27103
Principal Investigator: John J Smith, III, MD
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Winston-Salem, NC
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Wellspan Urogynecology and Pelvic Reconstructive Surgery
York, Pennsylvania 17403
Principal Investigator: Carlos Roberts, MD
Phone: 717-741-8124
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York, PA
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