Restorelle® Mesh Versus Native Tissue Repair for Prolapse
NCT ID: NCT02162615
Last Updated: 2022-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
810 participants
OBSERVATIONAL
2014-08-31
2021-11-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Flat Polypropylene Mesh in the Treatment of Uterine and Recurrent or Advanced Pelvic Organ Prolapse
NCT06225375
Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse Repair
NCT06296316
Smartmesh Technology in Pelvic Floor Repair Procedures
NCT03098641
Restorelle® Y Mesh vs. Vertessa® Lite Y Mesh for Laparoscopic and Robotic-assisted Laparoscopic Sacrocolpopexy
NCT03681223
Effectiveness Prolift+M Versus Conventional Vaginal Prolapse Surgery
NCT02231099
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Restorelle Direct Fix A
Anterior/Apical prolapse repair with Restorelle Direct Fix A
Restorelle Direct Fix A
Native Tissue Repair Anterior
Anterior/Apical prolapse repair with native tissue only
Native Tissue Repair Anterior
Restorelle Direct Fix P
Posterior/Apical prolapse repair with Restorelle Direct Fix P
Restorelle Direct Fix P
Native Tissue Repair Posterior
Posterior/Apical prolapse repair with native tissue only
Native Tissue Repair Posterior
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Restorelle Direct Fix A
Restorelle Direct Fix P
Native Tissue Repair Anterior
Native Tissue Repair Posterior
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Coloplast A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jan-Paul Roovers, MD
Role: PRINCIPAL_INVESTIGATOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sherry Thomas, M.D.
Agoura Hills, California, United States
Stanford University
Stanford, California, United States
SurgOne Pelvic Solutions Center
Denver, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Center for Urogynecology and Pelvic Surgery, Christiana Care Health System
Newark, Delaware, United States
MedStar Washington Hospital Center, National Center for Advanced Pelvic Surgery
Washington D.C., District of Columbia, United States
Rosemark Women Care Specialists
Idaho Falls, Idaho, United States
Andrew Shapiro
Owings Mills, Maryland, United States
Baystate Health System
Springfield, Massachusetts, United States
Female Pelvic Medicine & Urogynecology Institute of MI
Grand Rapids, Michigan, United States
Beyer Research
Kalamazoo, Michigan, United States
Adult & Pediatric Urology, PC
Omaha, Nebraska, United States
Cooper University Hospital
Camden, New Jersey, United States
Atlantic Health System
Morristown, New Jersey, United States
Premier Medical Group of Hudson Valley, PC
Poughkeepsie, New York, United States
Montefiore Medical Research Center
The Bronx, New York, United States
Novant Health Urogynecology
Charlotte, North Carolina, United States
Women's Pelvic Health and Continence Center
Hamlet, North Carolina, United States
Novant Health Clinical Research
Winston-Salem, North Carolina, United States
Akron Urogynecology Associates
Akron, Ohio, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
The Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, United States
Center for Women's Health of Lansdale
Lansdale, Pennsylvania, United States
The Female Pelvic Health Center
Newtown, Pennsylvania, United States
Wellspan Urogynecology and Pelvic Reconstructive Surgery
York, Pennsylvania, United States
Sanford Research
Sioux Falls, South Dakota, United States
Swan Urogynecology
Nashville, Tennessee, United States
Central Texas Urogynecology and Continence Center
Austin, Texas, United States
Scott D. Lauer, DO, PA
Colleyville, Texas, United States
Carilion Clinic New River Valley
Christiansburg, Virginia, United States
The Group for Women
Norfolk, Virginia, United States
Integrity Medical Research
Mountlake Terrace, Washington, United States
Centre for Advanced Reproductive Endosurgery
St Leonards, New South Wales, Australia
Mater Pelvic Health
Pimlico, Queensland, Australia
UZ Leuven
Leuven, , Belgium
Kingston General Hospital
Kingston, Ontario, Canada
Hôpital Maisonneuve-Rosemount
Montreal, Quebec, Canada
CHUS-CRC
Sherbrooke, Quebec, Canada
CHRU Lille
Lille, , France
CHU Nimes
Nîmes, , France
Bergman Clinics
Amsterdam, , Netherlands
AMC Medical Center
Amsterdam, , Netherlands
Bergman Clinics
Bilthoven, , Netherlands
Amphia Hospital
Breda, , Netherlands
Spaarne Gasthuis
Haarlem, , Netherlands
Maastricht UMC
Maastricht, , Netherlands
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
ISALA
Zwolle, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Sokol ER, Cosson M, Harris-Hicks JE, Mangel J, Thomas SL, Roovers JW. A Multicenter Prospective Study of Posterior Transvaginal Mesh Compared to Native Tissue Repair for Pelvic Organ Prolapse: 36 Month Outcomes. J Minim Invasive Gynecol. 2025 Oct;32(10):921-928. doi: 10.1016/j.jmig.2025.06.016. Epub 2025 Jun 26.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SU014
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.