The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy
This study is ongoing, but not recruiting participants.
Sponsor:
Emanuel Trabuco
Collaborator:
American Medical Systems
Information provided by (Responsible Party):
Emanuel Trabuco, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01497171
First received: December 20, 2011
Last updated: March 1, 2013
Last verified: October 2012
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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.
| Estimated Enrollment: | 214 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2015 (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
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: | March 1, 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 May 21, 2013