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Mesh
Mesh Surgery for Pelvic Organ Prolapse (Lite-Y Trial)
N/A
Waitlist Available
Led By Cecile A Unger, MD, MPH
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Lite-Y Trial Summary
This trial will compare outcomes of two types of surgery for vaginal prolapse. The hypothesis is that one surgery is not worse than the other.
Who is the study for?
This trial is for women over 18 who need surgery for pelvic organ prolapse, including vaginal vault prolapse. It's open to those undergoing laparoscopic or robotic-assisted sacrocolpopexy and may include related procedures like hysterectomy or incontinence repair. Women can't join if they can't consent, don't understand English, have unrelated surgeries needed, illnesses preventing laparoscopy, or require a different mesh type.Check my eligibility
What is being tested?
The study compares two types of surgical mesh: Restorelle® Y and Vertessa® Lite Y used in laparoscopic or robotic-assisted sacrocolpopexy for treating vaginal vault prolapse. The goal is to see if Vertessa® Lite Y is as effective as Restorelle® Y. Patients are randomly assigned one of the meshes during surgery.See study design
What are the potential side effects?
Potential side effects from the meshes could include discomfort at the surgical site, infection risk, bleeding complications, and possible mesh erosion into surrounding tissues which might require additional treatment.
Lite-Y Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite outcome measure of surgical success
Secondary outcome measures
Composite outcome measure of surgical success
Lite-Y Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Vertessa® Lite Y meshExperimental Treatment3 Interventions
All subjects will be predetermined by their surgeon to undergo either a laparoscopic or robotic assisted laparoscopic sacrocolpopexy depending upon their clinical evaluation. The participants will then be randomized to Vertessa® Y sacrocolpopexy
Group II: Restorelle® Y meshActive Control3 Interventions
All subjects will be predetermined by their surgeon to undergo either a laparoscopic or robotic assisted laparoscopic sacrocolpopexy depending upon their clinical evaluation. The participants will then be randomized to Restorelle® sacrocolpopexy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Robotic assisted laparoscopic sacrocolpopexy
2018
N/A
~110
Vertessa® Lite Y mesh
2018
N/A
~110
Laparoscopic sacrocolpopexy
2018
N/A
~110
Find a Location
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,026 Previous Clinical Trials
1,365,967 Total Patients Enrolled
Cecile A Unger, MD, MPHPrincipal InvestigatorAssistant Professor of Surgery. Center for Urogynecology and Pelvic Reconstructive Surgery; Obstetrics/Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland OH
Marie Fidela R Paraiso, MDPrincipal InvestigatorProfessor, Section Head of the Center for Urogynecology and Pelvic Reconstructive Surgery; Obstetrics/Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland OH
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Eligibility Criteria:
This trial includes the following eligibility criteria:- The primary surgeon may decide to perform additional procedures to treat conditions such as prolapse or incontinence during the study.Your surgeon has determined that you need a specific type of mesh for your sacrocolpopexy procedure.You cannot understand or speak English well.You have a medical condition that prevents you from having laparoscopy.This is not a screening criterion. It is a medical procedure called sacrocolpoperineopexy.
Research Study Groups:
This trial has the following groups:- Group 1: Restorelle® Y mesh
- Group 2: Vertessa® Lite Y mesh
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor presently recruiting participants?
"Based on the information provided at clinicaltrials.gov, this trial is no longer accepting new participants. It was originally advertised September 18th 2018 and last edited July 11th 2022. Nevertheless, 78 alternative trials are currently recruiting patients."
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