Restorelle® Mesh Versus Native Tissue Repair for Prolapse

January 25, 2022 updated by: Coloplast A/S

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
810

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 Nimes
  • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recurrence of Prolapse
Time Frame: 12 Month
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
Time Frame: 12 Month
12 Month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Recurrence of Prolapse
Time Frame: 12 Month
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
Time Frame: 36 Month
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
Time Frame: 36 Month
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
Time Frame: 36 months
36 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Additional adverse events
Time Frame: 36 months
36 months
Changes in Quality of Life scores for PFDI-20, PISQ-12, and PFIQ-7
Time Frame: 36 months
36 months
Subjects experiencing vaginal bulge
Time Frame: 36 months
36 months
Rates of revision and/or re-surgery
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Coloplast A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jan-Paul Roovers, MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 6, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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