The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy

This study has been terminated.
(Early termination of study due to changes in funding.)
Sponsor:
Collaborator:
American Medical Systems
Information provided by (Responsible Party):
Emanuel Trabuco, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01497171
First received: December 20, 2011
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Pelvic Organ Prolapse
Procedure: Elevate Mesh
Procedure: Anterior Colporrhaphy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Transvaginal Mesh Colposuspension for Anterior Vaginal Prolapse: the Elevate vs. Anterior Colporrhaphy Trial

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Comparison of the proportion of subjects in each group, who achieve anatomic success at 12 month follow-up. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 4
Study Start Date: November 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Elevate Mesh
Elevate transvaginal mesh - surgical repair of prolapse
Procedure: Elevate Mesh
Transvaginal mesh repair of anterior vaginal prolapse
Active Comparator: Anterior Colporrhaphy
Anterior colporrhaphy - surgical repair of prolapse
Procedure: Anterior Colporrhaphy
Traditional suture repair of anterior vaginal prolapse

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 MN. Mayo Clinic will serve as the data gathering and coordination site for this multicenter trial.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women older than 21 years of age
  • with symptomatic pelvic organ prolapse who opt for a vaginal repair
  • who require both apical and anterior compartment repairs
  • who are willing to return for follow-up visit
  • who understand and have signed informed consent to undergo randomization
  • all trial participants will 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01497171

Locations
United States, California
Kaiser-Permanente - North Valley
Roseville, California, United States, 95661
Kaiser-Permanente - Santa Clara
Santa Clara, California, United States, 95051
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, District of Columbia
Washington Hospital Center - MedStar Health
Washington, District of Columbia, United States, 20010
United States, Ohio
The Carl & Edyth Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, United States, 45219
Germany
St. Hedwig's Krankenhaus
Berlin, Germany, 10115
Sponsors and Collaborators
Emanuel Trabuco
American Medical Systems
Investigators
Principal Investigator: Emanuel Trabuco, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Emanuel Trabuco, Assistant Professor of Obstetrics-Gynegology, Consultant-OB/Gyn Surgery, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01497171     History of Changes
Other Study ID Numbers: 11-000247
Study First Received: December 20, 2011
Last Updated: October 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Cystocele
Bladder prolapse
Anterior prolapse
Vaginal prolapse
Uterine prolapse
Urinary incontinence

Additional relevant MeSH terms:
Prolapse
Uterine Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 23, 2014