Restorelle® Mesh Versus Native Tissue Repair for Prolapse
Restorelle® Transvaginal Mesh Versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse, Restorelle 522 Study
1 other identifier
observational
810
6 countries
49
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2014
Longer than P75 for all trials
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2014
CompletedFirst Posted
Study publicly available on registry
June 13, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2021
CompletedJanuary 27, 2022
January 1, 2022
5.5 years
June 11, 2014
January 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Recurrence of Prolapse
Recurrent Prolapse measured anatomically at the target compartment by leading edge of prolapse beyond the hymenal ring by POP-Q examination, or additional surgical treatment for pelvic organ prolapse in the target vaginal compartment(s), or patient reporting symptoms of vaginal bulging.
12 Month
Rate of device and procedure related serious adverse events
12 Month
Secondary Outcomes (4)
Recurrence of Prolapse
12 Month
Recurrence of Prolapse
36 Month
Recurrence of Prolapse
36 Month
Device or Procedure related AEs of interest
36 months
Other Outcomes (4)
Additional adverse events
36 months
Changes in Quality of Life scores for PFDI-20, PISQ-12, and PFIQ-7
36 months
Subjects experiencing vaginal bulge
36 months
- +1 more other outcomes
Study Arms (4)
Restorelle Direct Fix A
Anterior/Apical prolapse repair with Restorelle Direct Fix A
Native Tissue Repair Anterior
Anterior/Apical prolapse repair with native tissue only
Restorelle Direct Fix P
Posterior/Apical prolapse repair with Restorelle Direct Fix P
Native Tissue Repair Posterior
Posterior/Apical prolapse repair with native tissue only
Interventions
Eligibility Criteria
Adult female patients with pelvic organ prolapse who are candidates for transvaginal surgical repair.
You may qualify if:
- 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
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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Coloplast A/Slead
Study Sites (49)
Sherry Thomas, M.D.
Agoura Hills, California, 91301, United States
Stanford University
Stanford, California, 94305, United States
SurgOne Pelvic Solutions Center
Denver, Colorado, 80218, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Center for Urogynecology and Pelvic Surgery, Christiana Care Health System
Newark, Delaware, 19713, United States
MedStar Washington Hospital Center, National Center for Advanced Pelvic Surgery
Washington D.C., District of Columbia, 20010, United States
Rosemark Women Care Specialists
Idaho Falls, Idaho, 83404, United States
Andrew Shapiro
Owings Mills, Maryland, 21117, United States
Baystate Health System
Springfield, Massachusetts, 01199, United States
Female Pelvic Medicine & Urogynecology Institute of MI
Grand Rapids, Michigan, 49503, United States
Beyer Research
Kalamazoo, Michigan, 49009, United States
Adult & Pediatric Urology, PC
Omaha, Nebraska, 68114, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Atlantic Health System
Morristown, New Jersey, 07960, United States
Premier Medical Group of Hudson Valley, PC
Poughkeepsie, New York, 12601, United States
Montefiore Medical Research Center
The Bronx, New York, 10461, United States
Novant Health Urogynecology
Charlotte, North Carolina, 28210, United States
Women's Pelvic Health and Continence Center
Hamlet, North Carolina, 28345, United States
Novant Health Clinical Research
Winston-Salem, North Carolina, 27103, United States
Akron Urogynecology Associates
Akron, Ohio, 44333, United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
The Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, 18103, United States
Center for Women's Health of Lansdale
Lansdale, Pennsylvania, 19446, United States
The Female Pelvic Health Center
Newtown, Pennsylvania, 18940, United States
Wellspan Urogynecology and Pelvic Reconstructive Surgery
York, Pennsylvania, 17403, United States
Sanford Research
Sioux Falls, South Dakota, 57104, United States
Swan Urogynecology
Nashville, Tennessee, 37203, United States
Central Texas Urogynecology and Continence Center
Austin, Texas, 78758, United States
Scott D. Lauer, DO, PA
Colleyville, Texas, 76034, United States
Carilion Clinic New River Valley
Christiansburg, Virginia, 24073, United States
The Group for Women
Norfolk, Virginia, 23502, United States
Integrity Medical Research
Mountlake Terrace, Washington, 98042, United States
Centre for Advanced Reproductive Endosurgery
St Leonards, New South Wales, 2065, Australia
Mater Pelvic Health
Pimlico, Queensland, 4812, Australia
UZ Leuven
Leuven, 3000, Belgium
Kingston General Hospital
Kingston, Ontario, K7L 2VT, Canada
Hôpital Maisonneuve-Rosemount
Montreal, Quebec, H1T 2M4, Canada
CHUS-CRC
Sherbrooke, Quebec, J1H 5N4, Canada
CHRU Lille
Lille, 59037, France
CHU Nimes
Nîmes, 30029, France
Bergman Clinics
Amsterdam, 1081, Netherlands
AMC Medical Center
Amsterdam, 1105, Netherlands
Bergman Clinics
Bilthoven, 3723 MB, Netherlands
Amphia Hospital
Breda, 4819 EV, Netherlands
Spaarne Gasthuis
Haarlem, 2035 RC, Netherlands
Maastricht UMC
Maastricht, 6229 HX, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, 3435 CM, Netherlands
ISALA
Zwolle, 8025 AB, Netherlands
Related Publications (1)
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.
PMID: 40581283DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan-Paul Roovers, MD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2014
First Posted
June 13, 2014
Study Start
August 1, 2014
Primary Completion
January 15, 2020
Study Completion
November 6, 2021
Last Updated
January 27, 2022
Record last verified: 2022-01