The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy
Primary Purpose
Pelvic Organ Prolapse
Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Elevate Mesh
Anterior Colporrhaphy
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Cystocele, Bladder prolapse, Anterior prolapse, Vaginal prolapse, Uterine prolapse, Urinary incontinence
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- History of radical pelvic surgery
- History of pelvic radiation therapy
- Currently undergoing treatment for a malignancy
- Medically poor candidates for surgery
Sites / Locations
- Kaiser-Permanente - North Valley
- Kaiser-Permanente - Santa Clara
- Stanford University School of Medicine
- Washington Hospital Center - MedStar Health
- The Carl & Edyth Lindner Center for Research and Education at The Christ Hospital
- St. Hedwig's Krankenhaus
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Elevate Mesh
Anterior Colporrhaphy
Arm Description
Elevate transvaginal mesh - surgical repair of prolapse
Anterior colporrhaphy - surgical repair of prolapse
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01497171
First Posted
December 20, 2011
Last Updated
August 6, 2014
Sponsor
Emanuel Trabuco
Collaborators
American Medical Systems
1. Study Identification
Unique Protocol Identification Number
NCT01497171
Brief Title
The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy
Official Title
Safety and Efficacy of Transvaginal Mesh Colposuspension for Anterior Vaginal Prolapse: the Elevate vs. Anterior Colporrhaphy Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
Early termination of study due to changes in funding.
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emanuel Trabuco
Collaborators
American Medical Systems
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
Cystocele, Bladder prolapse, Anterior prolapse, Vaginal prolapse, Uterine prolapse, Urinary incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Elevate Mesh
Arm Type
Active Comparator
Arm Description
Elevate transvaginal mesh - surgical repair of prolapse
Arm Title
Anterior Colporrhaphy
Arm Type
Active Comparator
Arm Description
Anterior colporrhaphy - surgical repair of prolapse
Intervention Type
Procedure
Intervention Name(s)
Elevate Mesh
Intervention Description
Transvaginal mesh repair of anterior vaginal prolapse
Intervention Type
Procedure
Intervention Name(s)
Anterior Colporrhaphy
Intervention Description
Traditional suture repair of anterior vaginal prolapse
Primary Outcome Measure Information:
Title
Comparison of the Proportion of Subjects in Each Group, Who Achieve Anatomic Success at 12 Month Follow-up.
Description
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.
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
History of radical pelvic surgery
History of pelvic radiation therapy
Currently undergoing treatment for a malignancy
Medically poor candidates for surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emanuel Trabuco, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser-Permanente - North Valley
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Kaiser-Permanente - Santa Clara
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Washington Hospital Center - MedStar Health
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
The Carl & Edyth Lindner Center for Research and Education at The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
St. Hedwig's Krankenhaus
City
Berlin
ZIP/Postal Code
10115
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy
We'll reach out to this number within 24 hrs