Pelvic Organ ProlapseNCT02162615
Restorelle® Mesh Versus Native Tissue Repair for Prolapse
An observational study of Pelvic Organ Prolapse, run by Coloplast A/S at 49 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Restorelle Direct Fix A, Restorelle Direct Fix P and Native Tissue Repair Anterior
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 810 participants
- Where
- 49 sitesin 6 countries
- Study dates
- Aug 2014to 6 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult female patients with pelvic organ prolapse who are candidates for transvaginal surgical repair.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
49 sites in 6 countries.
49 sites in 6 countries
United States33 sites
Sherry Thomas, M.D.
Agoura Hills, California, 91301
Akron Urogynecology Associates
Akron, Ohio, 44333
The Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, 18103
Central Texas Urogynecology and Continence Center
Austin, Texas, 78758
Cooper University Hospital
Camden, New Jersey, 08103
Novant Health Urogynecology
Charlotte, North Carolina, 28210
Carilion Clinic New River Valley
Christiansburg, Virginia, 24073
Good Samaritan Hospital
Cincinnati, Ohio, 45220
MetroHealth Medical Center
Cleveland, Ohio, 44109
Scott D. Lauer, DO, PA
Colleyville, Texas, 76034
SurgOne Pelvic Solutions Center
Denver, Colorado, 80218
Female Pelvic Medicine & Urogynecology Institute of MI
Grand Rapids, Michigan, 49503
Women's Pelvic Health and Continence Center
Hamlet, North Carolina, 28345
Rosemark Women Care Specialists
Idaho Falls, Idaho, 83404
Beyer Research
Kalamazoo, Michigan, 49009
Center for Women's Health of Lansdale
Lansdale, Pennsylvania, 19446
Atlantic Health System
Morristown, New Jersey, 07960
Integrity Medical Research
Mountlake Terrace, Washington, 98042
Swan Urogynecology
Nashville, Tennessee, 37203
Yale University School of Medicine
New Haven, Connecticut, 06520
Center for Urogynecology and Pelvic Surgery, Christiana Care Health System
Newark, Delaware, 19713
The Female Pelvic Health Center
Newtown, Pennsylvania, 18940
The Group for Women
Norfolk, Virginia, 23502
Adult & Pediatric Urology, PC
Omaha, Nebraska, 68114
Andrew Shapiro
Owings Mills, Maryland, 21117
Premier Medical Group of Hudson Valley, PC
Poughkeepsie, New York, 12601
Sanford Research
Sioux Falls, South Dakota, 57104
Baystate Health System
Springfield, Massachusetts, 01199
Stanford University
Stanford, California, 94305
Montefiore Medical Research Center
The Bronx, New York, 10461
MedStar Washington Hospital Center, National Center for Advanced Pelvic Surgery
Washington D.C., District of Columbia, 20010
Novant Health Clinical Research
Winston-Salem, North Carolina, 27103
Wellspan Urogynecology and Pelvic Reconstructive Surgery
York, Pennsylvania, 17403
Netherlands8 sites
Bergman Clinics
Amsterdam, 1081
AMC Medical Center
Amsterdam, 1105
Bergman Clinics
Bilthoven, 3723 MB
Amphia Hospital
Breda, 4819 EV
Spaarne Gasthuis
Haarlem, 2035 RC
Maastricht UMC
Maastricht, 6229 HX
St. Antonius Ziekenhuis
Nieuwegein, 3435 CM
ISALA
Zwolle, 8025 AB
Canada3 sites
Kingston General Hospital
Kingston, Ontario, K7L 2VT
Hôpital Maisonneuve-Rosemount
Montreal, Quebec, H1T 2M4
CHUS-CRC
Sherbrooke, Quebec, J1H 5N4
Australia2 sites
Mater Pelvic Health
Pimlico, Queensland, 4812
Centre for Advanced Reproductive Endosurgery
St Leonards, New South Wales, 2065
About this study
Official title: 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.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Restorelle Direct Fix A, Restorelle Direct Fix P, Native Tissue Repair Anterior, Native Tissue Repair Posterior
- Keywords
- Pelvic Floor Disorder, Pelvic Organ Prolapse, Sexual Dysfunction, Mesh, POP, Transvaginal, Anterior, Posterior, Apical, Uterine Prolapse, Cystocele, Rectocele, Enterocele, Vaginal Vault Prolapse, Native Tissue Repair, Repair Augmented with Mesh, Pathological Conditions, Anatomical, Restorelle Direct Fix, Vaginal Mesh, Transvaginal Mesh
- Medical subject headings
- Pelvic Organ Prolapse, Pelvic Floor Disorders, Sexual Dysfunction, Physiological, Uterine Prolapse, Cystocele, Rectocele, Hernia, Pathological Conditions, Anatomical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restorelle Direct Fix ADevice
Restorelle Direct Fix PDevice
Native Tissue Repair AnteriorProcedure or surgery
Native Tissue Repair PosteriorProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Restorelle Direct Fix A | Anterior/Apical prolapse repair with Restorelle Direct Fix A Receives: Device: Restorelle Direct Fix A | |
| Native Tissue Repair Anterior | Anterior/Apical prolapse repair with native tissue only Receives: Procedure: Native Tissue Repair Anterior | |
| Restorelle Direct Fix P | Posterior/Apical prolapse repair with Restorelle Direct Fix P Receives: Device: Restorelle Direct Fix P | |
| Native Tissue Repair Posterior | Posterior/Apical prolapse repair with native tissue only Receives: Procedure: Native Tissue Repair Posterior |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Month
Rate of device and procedure related serious adverse events
Measured: 12 Month
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 36 Month
Device or Procedure related AEs of interest
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startAug 2014
- Primary completion15 Jan 2020
- Study completion6 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 810 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan-Paul Roovers, MD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162615
- Sponsor's protocol ID
- SU014
- Status last verified
- Jan 2022
- First submitted
- 11 Jun 2014
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 40581283
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restorelle® Transvaginal Mesh Versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse, Restorelle 522 Study
- ClinicalTrials.gov ID
- NCT02162615
- Acronym / sponsor ID
- SU014
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Pelvic Floor Disorder, Pelvic Organ Prolapse, Sexual Dysfunction, Mesh, POP, Transvaginal, Anterior, Posterior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 810 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Aug 2014 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 6 Nov 2021 (actual)
- First posted
- 13 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Restorelle Direct Fix A | – | Device: Restorelle Direct Fix AAnterior/Apical prolapse repair with Restorelle Direct Fix A |
| Native Tissue Repair Anterior | – | Procedure: Native Tissue Repair AnteriorAnterior/Apical prolapse repair with native tissue only |
| Restorelle Direct Fix P | – | Device: Restorelle Direct Fix PPosterior/Apical prolapse repair with Restorelle Direct Fix P |
| Native Tissue Repair Posterior | – | Procedure: Native Tissue Repair PosteriorPosterior/Apical prolapse repair with native tissue only |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult female patients with pelvic organ prolapse who are candidates for transvaginal surgical repair.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restorelle Direct Fix A | Device | Restorelle Direct Fix A |
| Restorelle Direct Fix P | Device | Restorelle Direct Fix P |
| Native Tissue Repair Anterior | Procedure or surgery | Native Tissue Repair Anterior |
| Native Tissue Repair Posterior | Procedure or surgery | Native Tissue Repair Posterior |
Primary outcome
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.
Rate of device and procedure related serious adverse events
Time frame: 12 Month
4 secondary outcomes
Recurrence of Prolapse
Time frame: 12 Month
Recurrence of Prolapse
Time frame: 36 Month
Recurrence of Prolapse
Time frame: 36 Month
Device or Procedure related AEs of interest
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Derived from this study: PubMed 40581283Sokol 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan-Paul Roovers, MD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
49 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by Coloplast A/S at 49 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Netherlands, Canada, Australia, France and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of Prolapse (time frame: 12 Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02162615, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.