Pelvic Organ ProlapseNCT02162628
Exair® Versus Native Tissue Repair for Prolapse
An observational study of Pelvic Organ Prolapse, run by Coloplast A/S at 14 sites in 2 countries.
Trial summary
The purpose of this study is to compare safety and effectiveness of the Exair Prolapse Repair System for treatment of pelvic organ prolapse to traditional native tissue repair through 36 months of follow-up. 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?
- Exair Prolapse Repair System and Total Native Tissue Repair
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 79 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Aug 2014to Dec 2015
- 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 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 14Show 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)
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States13 sites
Albany Medical Center
Albany, New York, 12208
The Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, 18103
Carillion Clinic OB/GYN
Christiansburg, Virginia, 24073
Advanced Urogynecology of Michigan
Dearborn, Michigan, 48124
Women's Health Advantage
Fort Wayne, Indiana, 46825
United Health Services
Johnson City, New York, 13790
Minnesota Women's Care
Maplewood, Minnesota, 55109
Atlantic Urogynecology Associates
Morristown, New Jersey, 07960
Princeton Urogynecology
Princeton, New Jersey, 08540
Progressive GYN Center
Savannah, Georgia, 31405
Vermont Urogynecology Associates, P.C.
Williston, Vermont, 05495
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103
Novant Health Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: Exair® Prolapse Repair System Versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse, Exair 522 Study
The purpose of this study is to compare safety and effectiveness of the Exair Prolapse Repair System for treatment of pelvic organ prolapse to traditional native tissue repair through 36 months of follow-up.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Exair Prolapse Repair System, Total Native Tissue Repair
- Keywords
- Pelvic Floor Disorder, Pelvic Organ Prolapse, Sexual Dysfunction, Mesh, POP, Transvaginal, Total Repair, Uterine Prolapse, Cystocele, Rectocele, Enterocele, Vaginal Vault Prolapse, Native Tissue Repair, Repair Augmented with Mesh, Pathological Conditions, Anatomical, Exair Prolapse Repair System, 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.
Exair Prolapse Repair SystemDevice
Total Native Tissue RepairProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Exair for Total Repair | Total repair with Exair Prolapse Repair System alone or in combination with native tissue repair Receives: Device: Exair Prolapse Repair System | |
| Total Native Tissue Repair | Total repair with native tissue only Receives: Procedure: Total Native Tissue Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of Prolapse
Recurrent prolapse is 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: 36 Month
Rate of device and procedure related adverse events
Measured: 36 Month
Secondary outcomes (2)
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: 36 Month
Rates of other adverse events
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 completionDec 2015
- Study completionDec 2015
Why it stopped: Device voluntarily withdrawn from commercial use by manufacturer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Lukban, DO, FACOG, Principal investigator, The Pelvic Solutions Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162628
- Sponsor's protocol ID
- SU019
- Status last verified
- Dec 2015
- First submitted
- 11 Jun 2014
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exair® Prolapse Repair System Versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse, Exair 522 Study
- ClinicalTrials.gov ID
- NCT02162628
- Acronym / sponsor ID
- SU019
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Pelvic Floor Disorder, Pelvic Organ Prolapse, Sexual Dysfunction, Mesh, POP, Transvaginal, Total Repair, Uterine Prolapse
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Device voluntarily withdrawn from commercial use by manufacturer
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (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 compare safety and effectiveness of the Exair Prolapse Repair System for treatment of pelvic organ prolapse to traditional native tissue repair through 36 months of follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exair for Total Repair | – | Device: Exair Prolapse Repair SystemTotal repair with Exair Prolapse Repair System alone or in combination with native tissue repair |
| Total Native Tissue Repair | – | Procedure: Total Native Tissue RepairTotal 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 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 (14 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 |
|---|---|---|
| Exair Prolapse Repair System | Device | Exair for Total Repair |
| Total Native Tissue Repair | Procedure or surgery | Total Native Tissue Repair |
Primary outcome
Recurrence of Prolapse
Time frame: 36 Month
Recurrent prolapse is 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 adverse events
Time frame: 36 Month
2 secondary outcomes
Recurrence of prolapse
Time frame: 36 Month
Rates of other adverse events
Time frame: 36 months
Results and safety
The study was stopped early (reason given: Device voluntarily withdrawn from commercial use by manufacturer). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
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Suzetrigine Following Urogynecologic Surgery: Investigation of Postoperative Pain Management
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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.
James Lukban, DO, FACOG principal investigator
The Pelvic Solutions Center
14 sites in 2 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 14 sites in 2 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 14 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: stopped early, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada. 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 was stopped early (reason given: Device voluntarily withdrawn from commercial use by manufacturer). Results are not available in the source record.
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: 36 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?
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 14 Dec 2015; AzTrials last refreshed its copy on 29 Oct 2026.