Flat Mesh for Pelvic Organ Prolapse

Age: 18+

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: Michigan Institution of Women's Health PC

Must not be taking: Systemic steroids, Immunosuppressives

Disqualifiers: Infections, Cancer history, Connective tissue disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and feasibility of using an ultra-lightweight flat polypropylene mesh for surgical treatment of pelvic organ prolapse. It aims to assist women whose previous prolapse surgeries were unsuccessful, those with severe prolapse symptoms, or those wishing to avoid a hysterectomy. Women who have completed childbearing and seek transvaginal mesh surgery for pelvic organ prolapse may be suitable candidates for this study. As a Phase 1 trial, the research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are taking systemic steroids or immunosuppressive treatments, you may not be eligible to participate.

What prior data suggests that this mesh is safe for pelvic organ prolapse surgery?

Research has shown that polypropylene mesh, such as the Restorelle® mesh used in this study, raises safety concerns. Some studies have reported issues like mesh exposure (when the mesh becomes visible through the skin) and encapsulation (when the body forms a tissue layer around the mesh). However, specific data on the ultra-lightweight Restorelle® mesh indicates that its safety largely depends on the surgeon's experience with this material.

Skilled surgeons who know how to handle the mesh have generally found it well-tolerated. Still, it's important to understand that, like any surgical material, potential risks exist. These can include discomfort and, in some cases, complications that might require further medical attention. Prospective participants should discuss these points with their doctor to gain personalized insights into what these findings mean for them. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

The Restorelle Flat Mesh is unique because it offers a customized approach to treating pelvic organ prolapse through transvaginal mesh surgery. Unlike some traditional surgical options that may use pre-shaped meshes, this treatment uses a flat sheet of polypropylene mesh that can be tailored precisely to the patient's anatomical needs. Researchers are excited about this flexibility, as it may lead to improved surgical outcomes and reduced complications by allowing surgeons to adapt the mesh to individual patients.

What evidence suggests that this flat mesh is effective for pelvic organ prolapse?

Research has shown that using polypropylene mesh in pelvic organ prolapse surgery can yield better results than using the body's own tissue. For instance, one study found no recurrence of prolapse when mesh was used in certain procedures. In this trial, participants will receive treatment with Restorelle® Flat Mesh, a very lightweight option suitable for vaginal surgery. This mesh is designed to support and stabilize the pelvic organs. Although the use of mesh has been debated, it remains common in 40-70% of prolapse repairs, often inserted through the vagina. ^{1 2 3 4 6}

Who Is on the Research Team?

Salil Khandwala, MD

Principal Investigator

Michigan Women's Institution of health PC.

Are You a Good Fit for This Trial?

This trial is for women with severe (stage III or IV) pelvic organ prolapse, those who've had previous unsuccessful repairs, or have symptomatic uterine prolapse but want to avoid a hysterectomy. Specific details on eligibility are not provided.

Inclusion Criteria

I agree to participate in the study and am aware of other surgical options.

I am a woman who is no longer able to have children.

I have a severe or recurring vaginal prolapse and am considering surgery with mesh.

Exclusion Criteria

I cannot or do not want to follow the study's follow-up plan.

I have had cancer in my pelvic organs before.

I have a condition like MS, spinal injury, or stroke that affects my bladder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Subjects undergo transvaginal mesh surgery using Restorelle® mesh

1 day

1 visit (in-person)

Immediate Post-operative Follow-up

Initial recovery and monitoring for immediate post-operative complications

1 month

Visits at 1 week and 1 month (in-person)

Long-term Follow-up

Participants are monitored for safety and effectiveness, including adverse events and mesh assessments

36 months

Visits at 3, 6, 12, 18, 24, and 36 months (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Flat Polypropylene Mesh

Trial Overview The study tests the safety and effectiveness of Restorelle® Flat Mesh, an ultra-lightweight mesh used in transvaginal surgery to repair pelvic organ prolapse.

How Is the Trial Designed?

Group I: Treatment with Restorelle Flat Mesh Experimental Treatment 1 Intervention

Subjects shall undergo transvaginal mesh surgery per the surgeon's specifications. Briefly, a sheet of Restorelle® Flat Mesh-(XL) shall be cut to the dimensions of the former Restorelle® Direct Fix Anterior and Posterior Mesh

Who Is Running the Clinical Trial?

Michigan Institution of Women's Health PC

Lead Sponsor

Trials

8

Recruited

390+

Published Research Related to This Trial

The use of surgical mesh in transvaginal repairs for pelvic organ prolapse is controversial, with significant safety concerns including mesh exposure, erosion, and infection, which can lead to serious complications and affect patients' quality of life.

Patients should be informed about the FDA's warnings and potential adverse outcomes associated with surgical mesh before undergoing surgery, ensuring they can make informed decisions about their treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An appraisal of the Food and Drug Administration warning on urogynecologic surgical mesh. Menchen, LC., Wein, AJ., Smith, AL.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10045074/

Polypropylene Pelvic Mesh: What Went Wrong and What ... Polypropylene (PP) pelvic mesh is a synthetic mesh made of PP polymer used to treat pelvic organ prolapse (POP). Its use has become highly controversial.

2. iu.coloplast.us iu.coloplast.us/products/restorelle/

Restorelle® Y-Mesh and Flat Mesh Restorelle® Y and Y Contour pre-shaped mesh is used as a bridging material for sacrocolposuspension/sacrocolpopexy (transabdominal placement via laparotomy, ...

3. nature.com nature.com/articles/s41598-025-07878-7

Retrospective comparative study on efficacy and safety of ... One-year follow-up demonstrated 0% recurrence in the lateral abdominal wall suspension group, compared to 5 cases of mild posterior vaginal wall ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0142961225000961

Profiling of the macrophage response to polypropylene ... Pelvic organ prolapse (POP) surgical repair with polypropylene mesh (PPM) offers improved anatomical outcomes compared to reconstruction using native tissue ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4550295/

Characterizing the ex vivo textile and structural properties ... Mesh is used in 40–70 % of prolapse repairs, with the majority (~75 %) being placed transvaginally [6]. However, there is a wide variety of mesh products ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1742706122003282

Mesh deformation: A mechanism underlying polypropylene ... Polypropylene meshes used in pelvic organ prolapse (POP) repair are hampered by complications. Most POP meshes are highly unstable after tensioning ex vivo, ...