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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is being done to evaluate the safety and feasibility of using flat polypropylene Restorelle® mesh, an ultra-lightweight mesh, for transvaginal use in surgically correcting certain specific cases of pelvic organ prolapse, such as recurrent (previous failed native tissue repair), large stage III or IV pelvic organ prolapse, and those with symptomatic uterine prolapse desiring uterine-sparing surgery (called hysteropexy).

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 data supports the effectiveness of the treatment Flat Polypropylene Mesh for pelvic organ prolapse?

Research shows that polypropylene mesh, like the Flat Polypropylene Mesh, is used in surgeries for pelvic organ prolapse and has been evaluated for its effectiveness and safety. However, complications such as mesh exposure and pain have been noted, suggesting that while it can be effective, there are risks involved. ^{1 2 3 4 5}

Is flat mesh for pelvic organ prolapse safe for humans?

The use of flat polypropylene mesh for pelvic organ prolapse has been associated with complications like mesh exposure, infection, and pelvic pain. The FDA has issued warnings about these risks, and while some studies suggest it can be safe for certain individuals, long-term safety data is still needed. ^{6 7 8 9 10}

How does the Flat Polypropylene Mesh treatment for pelvic organ prolapse differ from other treatments?

The Flat Polypropylene Mesh treatment for pelvic organ prolapse is unique because it uses a synthetic mesh made from polypropylene to support weakened pelvic tissues. This approach is different from non-mesh surgeries, but it has been controversial due to potential complications like mesh exposure and pain. The treatment's effectiveness and safety depend on the type of mesh and how it is applied. ^{1 4 11 12 13}

Research Team

Salil Khandwala, MD

Principal Investigator

Michigan Women's Institution of health PC.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Poland pubmed.ncbi.nlm.nih.gov

[Evaluation of safety and effectiveness of pelvic organ prolapse treatment with the use of polypropylene mesh depending on mesh and application technique]. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Outcomes and complications of transvaginal and abdominal custom-shaped light-weight polypropylene mesh used in repair of pelvic organ prolapse. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The use of implanted materials for treating women with pelvic organ prolapse and stress urinary incontinence. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Characterizing the ex vivo textile and structural properties of synthetic prolapse mesh products. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Outcomes and complications of trans-vaginal mesh repair using the Prolift™ kit for pelvic organ prolapse at 4 years median follow-up in a tertiary referral centre. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

An appraisal of the Food and Drug Administration warning on urogynecologic surgical mesh. [2022]

7. Singapore pubmed.ncbi.nlm.nih.gov

Immediate and perioperative outcomes of polypropylene mesh in pelvic floor repair in a predominantly obese population. [2020]

8. Australia pubmed.ncbi.nlm.nih.gov

Polypropylene mesh as an alternative option for uterine preservation in pelvic reconstruction in patients with uterine prolapse. [2022]

9. Ireland pubmed.ncbi.nlm.nih.gov

Long-term (8.5 years) analysis of the type and rate of reoperation after transvaginal mesh repair (Prolift®) in 349 patients. [2019]

10. Spain pubmed.ncbi.nlm.nih.gov

Complications of polypropylene mesh for the treatment of female pelvic floor disorders. [2011]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Polypropylene Pelvic Mesh: What Went Wrong and What Will Be of the Future? [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Association Between the Amount of Vaginal Mesh Used With Mesh Erosions and Repeated Surgery After Repairing Pelvic Organ Prolapse and Stress Urinary Incontinence. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Bladder erosion after 2 years from cystocele repair with type I polypropylene mesh. [2018]