Clinical trial NCT01497171: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pelvic Organ Prolapse
Keywords: Cystocele
Bladder prolapse
Anterior prolapse
Vaginal prolapse
Uterine prolapse
Urinary incontinence
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: American Medical Systems
First posted: 2011-12-22
Enrollment: 5
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Comparison of the Proportion of Subjects in Each Group, Who Achieve Anatomic Success at 12 Month Follow-up.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roseville
country: United States
facility: Kaiser-Permanente - North Valley
state: California
city: Santa Clara
country: United States
facility: Kaiser-Permanente - Santa Clara
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Washington
country: United States
facility: Washington Hospital Center - MedStar Health
state: District of Columbia
city: Cincinnati
country: United States
facility: The Carl & Edyth Lindner Center for Research and Education at The Christ Hospital
state: Ohio
city: Berlin
country: Germany
facility: St. Hedwig's Krankenhaus
Study officials:
affiliation: Mayo Clinic
name: Emanuel Trabuco, MD
role: PRINCIPAL_INVESTIGATOR
References: