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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02162615
Registration number
NCT02162615
Ethics application status
Date submitted
11/06/2014
Date registered
13/06/2014
Date last updated
27/01/2022
Titles & IDs
Public title
Restorelle® Mesh Versus Native Tissue Repair for Prolapse
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Scientific title
Restorelle® Transvaginal Mesh Versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse, Restorelle 522 Study
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Secondary ID [1]
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SU014
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pelvic Organ Prolapse
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Condition category
Condition code
Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Renal and Urogenital
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Other renal and urogenital disorders
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Reproductive Health and Childbirth
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Fetal medicine and complications of pregnancy
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Reproductive Health and Childbirth
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Childbirth and postnatal care
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Recurrence of Prolapse
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Assessment method [1]
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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.
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Timepoint [1]
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12 Month
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Primary outcome [2]
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Rate of device and procedure related serious adverse events
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Assessment method [2]
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Timepoint [2]
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12 Month
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Secondary outcome [1]
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Recurrence of Prolapse
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Assessment method [1]
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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.
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Timepoint [1]
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12 Month
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Secondary outcome [2]
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Recurrence of Prolapse
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Assessment method [2]
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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.
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Timepoint [2]
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36 Month
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Secondary outcome [3]
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Recurrence of Prolapse
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Assessment method [3]
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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.
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Timepoint [3]
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36 Month
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Secondary outcome [4]
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Device or Procedure related AEs of interest
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Assessment method [4]
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Timepoint [4]
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36 months
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Eligibility
Key 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
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Minimum age
18
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
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Actual
6/11/2021
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Sample size
Target
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Accrual to date
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Final
810
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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Centre for Advanced Reproductive Endosurgery - St Leonards
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Recruitment hospital [2]
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Mater Pelvic Health - Pimlico
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Recruitment postcode(s) [2]
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4812 - Pimlico
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Recruitment outside Australia
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United States of America
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California
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Colorado
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Amsterdam
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Nieuwegein
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Zwolle
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Coloplast A/S
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Address
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02162615
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Jan-Paul Roovers, MD
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Address
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02162615
Download to PDF