The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01497171
• Other study ID #: 11-000247
• Status: Terminated
• Phase: Phase 4
• First received: December 20, 2011
• Last updated: August 6, 2014
• Start date: November 2011
• Est. completion date: May 2013

Study information

• Verified date: August 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

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

Locations

Country	Name	City	State
Germany	St. Hedwig's Krankenhaus	Berlin
United States	The Carl & Edyth Lindner Center for Research and Education at The Christ Hospital	Cincinnati	Ohio
United States	Kaiser-Permanente - North Valley	Roseville	California
United States	Kaiser-Permanente - Santa Clara	Santa Clara	California
United States	Stanford University School of Medicine	Stanford	California
United States	Washington Hospital Center - MedStar Health	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Emanuel Trabuco	American Medical Systems

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months	No