Restorelle® Mesh Versus Native Tissue Repair for Prolapse

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Device: Restorelle Direct Fix A; Procedure: Native Tissue Repair Anterior; Device: Restorelle Direct Fix P; Procedure: Native Tissue Repair Posterior

• Study Type: Observational
• Enrollment (Actual): 810

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • St Leonards, New South Wales, Australia, 2065
      • Centre for Advanced Reproductive Endosurgery
  • Queensland
    • Pimlico, Queensland, Australia, 4812
      • Mater Pelvic Health
• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven
• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 2VT
      • Kingston General Hospital
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Hopital Maisonneuve-Rosemount
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • CHUS-CRC
• France
  • Lille, France, 59037
    • CHRU Lille
  • Nimes, France, 30029
    • CHU Nîmes
• Netherlands
  • Amsterdam, Netherlands, 1081
    • Bergman Clinics
  • Amsterdam, Netherlands, 1105
    • AMC Medical Center
  • Bilthoven, Netherlands, 3723 MB
    • Bergman Clinics
  • Breda, Netherlands, 4819 EV
    • Amphia Hospital
  • Haarlem, Netherlands, 2035 RC
    • Spaarne Gasthuis
  • Maastricht, Netherlands, 6229 HX
    • Maastricht UMC
  • Nieuwegein, Netherlands, 3435 CM
    • St. Antonius Ziekenhuis
  • Zwolle, Netherlands, 8025 AB
    • Isala
• United States
  • California
    • Agoura Hills, California, United States, 91301
      • Sherry Thomas, M.D.
    • Stanford, California, United States, 94305
      • Stanford University
  • Colorado
    • Denver, Colorado, United States, 80218
      • SurgOne Pelvic Solutions Center
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University School Of Medicine
  • Delaware
    • Newark, Delaware, United States, 19713
      • Center for Urogynecology and Pelvic Surgery, Christiana Care Health System
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center, National Center for Advanced Pelvic Surgery
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Rosemark Women Care Specialists
  • Maryland
    • Owings Mills, Maryland, United States, 21117
      • Andrew Shapiro
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Baystate Health System
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Female Pelvic Medicine & Urogynecology Institute of MI
    • Kalamazoo, Michigan, United States, 49009
      • Beyer Research
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Adult & Pediatric Urology, PC
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
    • Morristown, New Jersey, United States, 07960
      • Atlantic Health System
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Research Center
    • Poughkeepsie, New York, United States, 12601
      • Premier Medical Group of Hudson Valley, PC
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Novant Health Urogynecology
    • Hamlet, North Carolina, United States, 28345
      • Women's Pelvic Health and Continence Center
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health Clinical Research
  • Ohio
    • Akron, Ohio, United States, 44333
      • Akron Urogynecology Associates
    • Cincinnati, Ohio, United States, 45220
      • Good Samaritan Hospital
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • The Institute for Female Pelvic Medicine and Reconstructive Surgery
    • Lansdale, Pennsylvania, United States, 19446
      • Center for Women's Health of Lansdale
    • Newtown, Pennsylvania, United States, 18940
      • The Female Pelvic Health Center
    • York, Pennsylvania, United States, 17403
      • Wellspan Urogynecology and Pelvic Reconstructive Surgery
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Sanford Research
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Swan Urogynecology
  • Texas
    • Austin, Texas, United States, 78758
      • Central Texas Urogynecology and Continence Center
    • Colleyville, Texas, United States, 76034
      • Scott D. Lauer, DO, PA
  • Virginia
    • Christiansburg, Virginia, United States, 24073
      • Carilion Clinic New River Valley
    • Norfolk, Virginia, United States, 23502
      • The Group for Women
  • Washington
    • Mountlake Terrace, Washington, United States, 98042
      • Integrity Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Adult female patients with pelvic organ prolapse who are candidates for transvaginal surgical repair.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Restorelle Direct Fix A; Anterior/Apical prolapse repair with Restorelle Direct Fix A	Device: Restorelle Direct Fix A
Native Tissue Repair Anterior; Anterior/Apical prolapse repair with native tissue only	Procedure: Native Tissue Repair Anterior
Restorelle Direct Fix P; Posterior/Apical prolapse repair with Restorelle Direct Fix P	Device: Restorelle Direct Fix P
Native Tissue Repair Posterior; Posterior/Apical prolapse repair with native tissue only	Procedure: Native Tissue Repair Posterior

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of Prolapse	Recurrent prolapse is measured anatomically by leading edge of prolapse in the target compartment at or 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
Recurrence of Prolapse	Recurrent Prolapse is measured anatomically by leading edge of prolapse in the target compartment 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.	36 Month
Recurrence of Prolapse	Recurrent Prolapse measured anatomically by leading edge of prolapse in the target compartment at or 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.	36 Month
Device or Procedure related AEs of interest		36 months

Other Outcome Measures

Outcome Measure	Time Frame
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
Rates of revision and/or re-surgery	36 months

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Jan-Paul Roovers, MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): January 15, 2020
• Study Completion (Actual): November 6, 2021

Study Registration Dates

• First Submitted: June 11, 2014
• First Submitted That Met QC Criteria: June 11, 2014
• First Posted (Estimate): June 13, 2014

Study Record Updates

• Last Update Posted (Actual): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 25, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Anterior; Cystocele; Pelvic Organ Prolapse; Mesh; POP; Sexual Dysfunction; Transvaginal; Posterior; Pathological Conditions, Anatomical; Rectocele; Native Tissue Repair; Repair Augmented with Mesh; Pelvic Floor Disorder; Apical; Uterine Prolapse; Enterocele; Vaginal Vault Prolapse; Restorelle Direct Fix; Vaginal Mesh; Transvaginal Mesh
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: SU014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No