Flat Polypropylene Mesh in the Treatment of Uterine and Recurrent or Advanced Pelvic Organ Prolapse

NCT06225375 | Unknown Phase 1 FDA Device

• 1 other identifier: 20210803
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (2)

• Primary Safety outcome

  To determine the proportion of subjects with mesh exposures

  12 -36 months post operative

• Primary efficacy outcome

  To determine the proportion of subjects with surgical success

  up to 36 months post operative

Secondary Outcomes (1)

• Adverse events

  intraoperative to 36 months

Study Arms (1)

Treatment with Restorelle Flat Mesh

OTHER

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

Device: Restorelle® Flat Mesh

Interventions

Restorelle® Flat Mesh DEVICE

Pelvic organ prolapse repair using Restorelle® Flat Mesh

Treatment with Restorelle Flat Mesh

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female subjects who have completed childbearing,
• Subjects have failed conservative management for POP and desire a surgical option using transvaginal mesh, and who have a:
• recurrent vaginal prolapse after a prior failed native tissue repair, OR,
• ≥ stage II uterine prolapse where a surgeon would typically perform a hysterectomy if native tissue repair were to be performed, OR,
• large pelvic organ prolapse (overall stage of prolapse ≥ stage III) where the risk of recurrence is high if native tissue repair is performed
• Subjects with a uterus desire a uterine-sparing procedure called hysteropexy
• The subject will provide written informed consent acknowledging her desire to participate in the study using transvaginally placed nonabsorbable mesh with the explicit understanding that there are other surgical options available to her, including but not limited to, transabdominal sacrocolpopexy, sacrospinous ligament fixation, and hysterectomy with vaginal wall repair with support.

You may not qualify if:

• Subject is unable or unwilling to comply with the follow-up regimen,
• Subject cannot complete study questionnaires,
• Lacks English competency,
• Declines to participate in the investigation,
• Active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI), or tissue necrosis,
• History of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical),
• Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area,
• Subject has taken systemic steroids (within the last month), or immunosuppressive or immunomodulatory treatment (within the last 3 months),
• Subject has a systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan syndrome, Ehlers Danlos, collagenosis, polymyositis or polymyalgia rheumatica),
• Chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis,
• Known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury, or stroke with residual neurologic deficit),
• Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis),
• Subject is unable to put her legs up in the dorsal lithotomy position due to hip arthritis,
• Subject is currently participating in or plans to participate in another device or drug study during this study,
• Known sensitivity to polypropylene,

Sponsors & Collaborators

• Michigan Institution of Women's Health PC: lead

Study Sites (1)

Michigan Women's Institution of Health PC.

Dearborn, Michigan, 48124, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Salil Khandwala, MD

  Michigan Women's Institution of health PC.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Model Details: This will be a single-center, open-label, prospective clinical trial of 30 subjects undergoing pelvic organ prolapse repair using the Restorelle® Flat Mesh in the treatment of uterine (by uterine-sparing hysteropexy) and recurrent or advanced pelvic organ prolapse. They will be followed for a period of 36 months. Eligible subjects shall undergo a detailed medical history and physical exam including a Pelvic Organ Prolapse Quantification (POP-Q)13 system assessment to determine the degree of prolapse. Validated self-reported questionnaires will be completed at baseline including the PFDI-20, PFIQ-7, MESA, and PISQ-12. Baseline demographic information shall be documented. A pelvic ultrasound assessment will be performed to assess the pelvic prolapse. Subjects shall undergo transvaginal mesh surgery per the surgeon's specifications.

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: January 25, 2024
• Study Start: September 1, 2021
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: January 25, 2024

Record last verified: 2024-01

Locations

US (1)