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

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

sites

Institute for Female Pelvic Medicine and Reconstructive Surgery

Allentown, Pennsylvania 18105

Principal Investigator: Vincent Lucente, MD, MBA

Phone: 610-435-9575

from

Allentown, PA

Sherry Thomas, M.D.

Agoura Hills, California 91301

Principal Investigator: Sherry Thomas, MD, MPH

Phone: 818-991-0988

from

Agoura Hills, CA

Akron Urogynecology Associates

Akron, Ohio 44313

Principal Investigator: Costas Apostolis, MD

Phone: 330-344-7681

from

Akron, OH

Central Texas Urogynecology and Continence Center

Austin, Texas 78758

Principal Investigator: Tomas Antonini, MD

Phone: 512-716-0861

from

Austin, TX

Montefiore Medical Research Center

Bronx, New York 10461

Principal Investigator: Keith Downing, MD

Phone: 718-405-8200

from

Bronx, NY

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...

from

Camden, NJ

Novant Health Urogynecology

Charlotte, North Carolina 28210

Principal Investigator: William Porter, MD

Phone: 704-574-5157

from

Charlotte, NC

Carilion Clinic New River Valley

Christiansburg, Virginia 24073

Principal Investigator: Tamera Howell, MD

from

Christiansburg, VA

Good Samaritan Hospital

Cincinnati, Ohio 45220

Principal Investigator: Steven Kleeman, MD, FACOG

Phone: 513-463-4308

from

Cincinnati, OH

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...

from

Cleveland, OH

Scott D. Lauer, DO, PA

Colleyville, Texas 76034

Principal Investigator: Scott D Lauer, DO

from

Colleyville, TX

SurgOne Pelvic Solutions Center

Denver, Colorado 80218

Principal Investigator: James Lukban, DO

Phone: 720-205-4537

from

Denver, CO

Female Pelvic Medicine & Urogynecology Institute of MI

Grand Rapids, Michigan 49503

Principal Investigator: Douglas Van Drie, MD

Phone: 616-588-1800

from

Grand Rapids, MI

Women's Pelvic Health and Continence Center

Hamlet, North Carolina 28345

Principal Investigator: Janet Harris-Hicks, MD

from

Hamlet, NC

Rosemark Women Care Specialists

Idaho Falls, Idaho 83404

Principal Investigator: Jason Gundersen, MD

Phone: 208-557-2982

from

Idaho Falls, ID

Beyer Research

Kalamazoo, Michigan 49009

Principal Investigator: Roger Beyer, MD

Phone: 269-372-7800

from

Kalamazoo, MI

Center for Women's Health of Lansdale

Lansdale, Pennsylvania 19446

Principal Investigator: Donald DeBrakeleer, DO

Phone: 215-368-1950

from

Lansdale, PA

Atlantic Health System

Morristown, New Jersey 07960

Principal Investigator: Charbel Salamon, MD, MS

Phone: 973-971-7267

from

Morristown, NJ

Integrity Medical Research

Mountlake Terrace, Washington 98043

Principal Investigator: Karny Jacoby, MD, CPI

from

Mountlake Terrace, WA

Swan Urogynecology

Nashville, Tennessee 37203

Principal Investigator: Michael C. Swan, MD, MBA

from

Nashville, TN

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...

from

New Haven, CT

Center for Urogynecology and Pelvic Surgery, Christiana Care Health System

Newark, Delaware 19713

Principal Investigator: Babak Vakili, MD, FACOG

Phone: 302-733-3056

from

Newark, DE

The Female Pelvic Health Center

Newtown, Pennsylvania 18940

Principal Investigator: Stephanie Molden, MD

Phone: 215-504-8900

from

Newtown, PA

The Group for Women

Norfolk, Virginia 23502

Principal Investigator: Mohamed-Mehdi Parva, MD

Phone: 757-471-3375

from

Norfolk, VA

Adult and Pediatric Urology P.C

Omaha, Nebraska 68114

Principal Investigator: Rebecca McCrery, MD

Phone: 402-399-7892

from

Omaha, NE

Andrew Shapiro

Owings Mills, Maryland 21117

Principal Investigator: Andrew M Shapiro, MD

Phone: 443-471-5873

from

Owings Mills, MD

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...

from

Poughkeepsie, NY

Sanford Research

Sioux Falls, South Dakota 65104

Principal Investigator: Kevin Benson, MD, MS

Phone: 605-328-1389

from

Sioux Falls, SD

Baystate Health System

Springfield, Massachusetts 01199

Principal Investigator: Keisha Jones, MD

Phone: 413-794-7045

from

Springfield, MA

Centre for Advanced Reproductive Endosurgery

69 Christie Street
St Leonards, New South Wales 2065

Principal Investigator: Alan Lam, MD

from

St Leonards,

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...

from

Stanford, CA

MedStar Washington Hospital Center, National Center for Advanced Pelvic Surgery

Washington, District of Columbia 20010

Principal Investigator: Andrew Sokol, MD

from

Washington,

Novant Health Clinical Research

Winston-Salem, North Carolina 27103

Principal Investigator: John J Smith, III, MD

from

Winston-Salem, NC

Wellspan Urogynecology and Pelvic Reconstructive Surgery

York, Pennsylvania 17403

Principal Investigator: Carlos Roberts, MD

Phone: 717-741-8124

from

York, PA

Restorelle® Mesh Versus Native Tissue Repair for Prolapse

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

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