Pelvic Organ ProlapsePhase 4NCT01497171
The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy
A Phase 4 study testing Elevate Mesh and Anterior Colporrhaphy in people with Pelvic Organ Prolapse, run by Emanuel Trabuco at 6 sites in 2 countries.
Trial summary
This study is designed to compare the safety and efficacy of a commercially available mesh kit used for surgical repair of anterior vaginal wall prolapse with traditional suture repair surgery. Read more about this study
- Who is it for?
- Ages 21 to 80 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Elevate Mesh and Anterior Colporrhaphy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Nov 2011to May 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with symptomatic pelvic organ prolapse who opt for a vaginal repair
- Require both apical and anterior compartment repairs
- Willing to return for follow-up visit
- Understand and have signed informed consent to undergo randomization
- Need both an apical and anterior repair
- All trial participants who have a uterus will require a hysterectomy
Who cannot join
- Known or suspected vulvodynia
- Known or suspected interstitial cystitis
- History of chronic pelvic pain
- Current pregnancy
- Desire to maintain fertility
- History of reconstructive pelvic surgery with synthetic mesh
Show all 10Show fewer
- History of radical pelvic surgery
- History of pelvic radiation therapy
- Currently undergoing treatment for a malignancy
- Medically poor candidates for surgery
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
The Carl & Edyth Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, 45219
Kaiser-Permanente - North Valley
Roseville, California, 95661
Kaiser-Permanente - Santa Clara
Santa Clara, California, 95051
Stanford University School of Medicine
Stanford, California, 94305
Washington Hospital Center - MedStar Health
Washington D.C., District of Columbia, 20010
About this study
Official title: Safety and Efficacy of Transvaginal Mesh Colposuspension for Anterior Vaginal Prolapse: the Elevate vs. Anterior Colporrhaphy Trial
This study is designed to compare the safety and efficacy of a commercially available mesh kit used for surgical repair of anterior vaginal wall prolapse with traditional suture repair surgery.
Read the detailed description
This is a multicenter, double blinded, randomized controlled trial, comparing Elevate® System with Interpro® Lite™, Anterior and Apical Prolapse Repair System (American Medical Systems) and Anterior Colporrhaphy (anterior suture repair) in women with symptomatic pelvic organ prolapse, who have opted to have surgical repair.
The goals of the study are to compare both efficacy and safety of the two procedures and to compare the surgical impact of mesh and suture repairs on vaginal function.
The principal investigator is from Mayo Clinic in Rochester, Minnesota. Mayo Clinic will serve as the data gathering and coordination site for this multicenter trial.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Elevate Mesh, Anterior Colporrhaphy
- Keywords
- Cystocele, Bladder prolapse, Anterior prolapse, Vaginal prolapse, Uterine prolapse, Urinary incontinence
- Medical subject headings
- Pelvic Organ Prolapse, Cystocele, Uterine Prolapse, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elevate MeshProcedure or surgery
Transvaginal mesh repair of anterior vaginal prolapse
Anterior ColporrhaphyProcedure or surgery
Traditional suture repair of anterior vaginal prolapse
| Study group | Role | What they receive |
|---|---|---|
| Elevate Mesh | Active comparator | Elevate transvaginal mesh - surgical repair of prolapse Receives: Procedure: Elevate Mesh |
| Anterior Colporrhaphy | Active comparator | Anterior colporrhaphy - surgical repair of prolapse Receives: Procedure: Anterior Colporrhaphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the Proportion of Subjects in Each Group, Who Achieve Anatomic Success at 12 Month Follow-up.
Anatomical success will be measured using a composite index including: lack of specific prolapse symptoms, no interval treatment and no observed prolapse beyond 1 cm from the hymen.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: Early termination of study due to changes in funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emanuel Trabuco
- Sponsor type
- University, hospital or other
- Collaborators
- American Medical Systems
- Responsible party
- Sponsor-investigator, Emanuel Trabuco, Mayo Clinic
- Investigators
- Emanuel Trabuco, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497171
- Sponsor's protocol ID
- 11-000247
- Status last verified
- Aug 2014
- First submitted
- 20 Dec 2011
- Last updated
- 21 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Transvaginal Mesh Colposuspension for Anterior Vaginal Prolapse: the Elevate vs. Anterior Colporrhaphy Trial
- ClinicalTrials.gov ID
- NCT01497171
- Acronym / sponsor ID
- 11-000247
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Cystocele, Bladder prolapse, Anterior prolapse, Vaginal prolapse, Uterine prolapse, Urinary incontinence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination of study due to changes in funding.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Emanuel TrabucoUniversity, hospital or other
- Collaborators
- American Medical Systems
- Study start
- Nov 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 22 Dec 2011 (estimated)
- Results
- Posted 21 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to compare the safety and efficacy of a commercially available mesh kit used for surgical repair of anterior vaginal wall prolapse with traditional suture repair surgery.
Detailed description
This is a multicenter, double blinded, randomized controlled trial, comparing Elevate® System with Interpro® Lite™, Anterior and Apical Prolapse Repair System (American Medical Systems) and Anterior Colporrhaphy (anterior suture repair) in women with symptomatic pelvic organ prolapse, who have opted to have surgical repair.
The goals of the study are to compare both efficacy and safety of the two procedures and to compare the surgical impact of mesh and suture repairs on vaginal function.
The principal investigator is from Mayo Clinic in Rochester, Minnesota. Mayo Clinic will serve as the data gathering and coordination site for this multicenter trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elevate Mesh | Active comparator | Procedure: Elevate MeshElevate transvaginal mesh - surgical repair of prolapse |
| Anterior Colporrhaphy | Active comparator | Procedure: Anterior ColporrhaphyAnterior colporrhaphy - surgical repair of prolapse |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women with symptomatic pelvic organ prolapse who opt for a vaginal repair
- Require both apical and anterior compartment repairs
- Willing to return for follow-up visit
- Understand and have signed informed consent to undergo randomization
- Need both an apical and anterior repair
Key exclusion criteria (10 listed)
- Known or suspected vulvodynia
- Known or suspected interstitial cystitis
- History of chronic pelvic pain
- Current pregnancy
- Desire to maintain fertility
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 |
|---|---|---|
| Elevate MeshTransvaginal mesh repair of anterior vaginal prolapse | Procedure or surgery | Elevate Mesh |
| Anterior ColporrhaphyTraditional suture repair of anterior vaginal prolapse | Procedure or surgery | Anterior Colporrhaphy |
Primary outcome
Comparison of the Proportion of Subjects in Each Group, Who Achieve Anatomic Success at 12 Month Follow-up.
Time frame: 12 months
Anatomical success will be measured using a composite index including: lack of specific prolapse symptoms, no interval treatment and no observed prolapse beyond 1 cm from the hymen.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Emanuel Trabuco, MD principal investigator
Mayo Clinic
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Elevate Mesh and Anterior Colporrhaphy in people with Pelvic Organ Prolapse, run by Emanuel Trabuco at 6 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 6 inclusion and 10 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 21 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Comparison of the Proportion of Subjects in Each Group, Who Achieve Anatomic Success at 12 Month Follow-up. (time frame: 12 months). 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 21 Aug 2014.