The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy

This study is ongoing, but not recruiting participants.

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: March 1, 2013

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 20, 2011

Last Updated Date

March 1, 2013

Start Date ^ICMJE

November 2011

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01497171 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy

Official Title ^ICMJE

Safety and Efficacy of Transvaginal Mesh Colposuspension for Anterior Vaginal Prolapse: the Elevate vs. Anterior Colporrhaphy Trial

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment

Condition ^ICMJE

Pelvic Organ Prolapse

Intervention ^ICMJE

Procedure: Elevate Mesh
Transvaginal mesh repair of anterior vaginal prolapse
Procedure: Anterior Colporrhaphy
Traditional suture repair of anterior vaginal prolapse

Study Arm (s)

Active Comparator: Elevate Mesh
Elevate transvaginal mesh - surgical repair of prolapse

Intervention: Procedure: Elevate Mesh
Active Comparator: Anterior Colporrhaphy
Anterior colporrhaphy - surgical repair of prolapse

Intervention: Procedure: Anterior Colporrhaphy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

214

Estimated Completion Date

December 2016

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

21 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Germany

Administrative Information

NCT Number ^ICMJE

NCT01497171

Other Study ID Numbers ^ICMJE

11-000247

Has Data Monitoring Committee

Responsible Party

Emanuel Trabuco, Mayo Clinic

Study Sponsor ^ICMJE

Emanuel Trabuco

Collaborators ^ICMJE

American Medical Systems

Investigators ^ICMJE

Principal Investigator:

Emanuel Trabuco, MD

Mayo Clinic

Information Provided By

Mayo Clinic

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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