Safety and Efficacy of Transvaginal Mesh Colposuspension for Anterior Vaginal Prolapse: the Elevate vs. Anterior Colporrhaphy Trial
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Pelvic Organ Prolapse
- Sponsor
- Emanuel Trabuco
- Enrollment
- 5
- Locations
- 6
- Primary Endpoint
- Comparison of the Proportion of Subjects in Each Group, Who Achieve Anatomic Success at 12 Month Follow-up.
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
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.
Investigators
Emanuel Trabuco
Assistant Professor of Obstetrics-Gynegology, Consultant-OB/Gyn Surgery
Mayo Clinic
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
Outcomes
Primary Outcomes
Comparison of the Proportion of Subjects in Each Group, Who Achieve Anatomic Success at 12 Month Follow-up.
Time Frame: 12 months
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.