Restorelle® Y Mesh vs. Vertessa® Lite Y Mesh for Laparoscopic and Robotic-assisted Laparoscopic Sacrocolpopexy

Completed · Not applicable

Conditions studied: Vaginal Vault Prolapse

In brief

This is a randomized clinical trial to compare outcomes between the Restorelle® Y mesh and Vertessa® lite Y mesh for the treatment of vaginal vault prolapse. Hypothesis: Vertessa® lite Y mesh is not inferior to Restorelle® Y mesh for the treatment of vaginal vault prolapse

Key facts

Study ID

NCT03681223

Run by

The Cleveland Clinic

People needed

106

Starts

2018-09-18

Expected to finish

2023-12-19

Last updated by the study team

2026-01-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18, who are to undergo laparoscopic or robotic laparoscopic sacrocolpopexy for pelvic organ prolapse
• Other concomitant laparoscopic or prolapse and anti-incontinence procedures (e.g., laparoscopic supracervical hysterectomy, cystocele repair, rectocele repair or mid-urethral sling procedures) will be performed at the primary surgeon's discretion.

You may not qualify if…

• Inability to comprehend written and/or spoken English
• Inability to provide informed consent
• Medical illness precluding laparoscopy
• Need for concomitant surgeries not related to pelvic organ prolapse or incontinence
• Sacrocolpoperineopexy
• Need for dual flat mesh for sacrocolpopexy procedure (determined by surgeon)

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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