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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
Emanuel Trabuco
About
Eligibility
Locations
Arms
Outcomes
Full info

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

21 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
December 20, 2011
Last Updated
August 6, 2014
Sponsor
Emanuel Trabuco
Collaborators
American Medical Systems
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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

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The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy

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