What side effects are associated with this type of intervention?

The most common side effects of treatments for vaginal vault prolapse using mesh implants, such as Restorelle® Y mesh and Vertessa® lite Y mesh, include mesh erosion, infection, pain, urinary problems, and organ perforation. Surgical complications like bleeding and anesthesia-related risks are also possible.

What prior FDA approvals exist?

The FDA has approved various mesh products for the treatment of vaginal vault prolapse, which provide structural support to the vaginal walls. These include the Restorelle® Y mesh and Vertessa® lite Y mesh, both of which are designed for use in laparoscopic and robotic-assisted laparoscopic sacrocolpopexy. These meshes aim to restore the normal anatomy by providing durable support to the vaginal apex, thereby addressing prolapse effectively.

What other types of research exist?

Promising novel alternatives to Restorelle® Y mesh and Vertessa® lite Y mesh for vaginal vault prolapse treatment in 2024 include: 1) Titanized polypropylene mesh, which offers enhanced biocompatibility and reduced inflammatory response. 2) Biologic grafts such as porcine dermis or human acellular dermal matrix, which are designed to integrate with the patient's tissue and reduce the risk of erosion and infection. 3) Lightweight, large-pore synthetic meshes that aim to provide sufficient support while minimizing complications. These options are being explored for their potential to improve patient outcomes and reduce adverse events associated with traditional mesh products.

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Mesh

Mesh Surgery for Pelvic Organ Prolapse (Lite-Y Trial)

N/A

Waitlist Available

Led By Marie Fidela R Paraiso, MD

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

No Placebo-Only Group

Summary

This trial compares two types of surgical mesh used in women with vaginal vault prolapse. The mesh supports the vaginal wall by attaching it to a ligament in the lower back, preventing it from sagging. The study aims to see if the newer type of mesh is as effective as the older type. The older type has been previously studied for its effectiveness in treating vaginal prolapse, with comparisons made to other mesh types and traditional methods.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite outcome measure of surgical success

Secondary study objectives

Composite outcome measure of surgical success

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vertessa® Lite Y mesh

2018

N/A

~110

Laparoscopic sacrocolpopexy

2018

N/A

~150

Robotic assisted laparoscopic sacrocolpopexy

2018

N/A

~110

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for vaginal vault prolapse, such as the Restorelle® Y mesh and Vertessa® lite Y mesh, involve the use of synthetic mesh to provide structural support to the vaginal vault. These meshes are designed to reinforce the weakened pelvic tissues, thereby restoring the normal anatomical position of the vaginal vault. The mesh acts as a scaffold, allowing for tissue integration and long-term support. This is crucial for patients as it helps to alleviate symptoms such as pelvic pressure, urinary incontinence, and sexual dysfunction, thereby improving their quality of life.

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,049 Previous Clinical Trials

1,370,646 Total Patients Enrolled

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

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