Search / Trial NCT06225375

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

Launched by MICHIGAN INSTITUTION OF WOMEN'S HEALTH PC · Jan 15, 2024

Trial Information

Current as of October 07, 2024

Unknown status

Keywords

Description

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).Subjects shall undergo transvaginal mesh surgery per the surgeon's specifications. The surgical procedure may include either a posterior Restorelle or an anterior R...

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • * 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:
  • 1. recurrent vaginal prolapse after a prior failed native tissue repair, OR,
  • 2. ≥ stage II uterine prolapse where a surgeon would typically perform a hysterectomy if native tissue repair were to be performed, OR,
  • 3. 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.
  • Exclusion Criteria:
  • * 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,
  • * Previous prolapse repair with mesh in the target compartment(s)

About Michigan Institution Of Women's Health Pc

The Michigan Institution of Women's Health PC is a dedicated clinical trial sponsor committed to advancing women's health through innovative research and evidence-based practices. With a focus on understanding and addressing the unique health needs of women, the institution conducts rigorous clinical trials that contribute to the development of new therapies and interventions. By collaborating with leading healthcare professionals and researchers, the Michigan Institution of Women's Health PC aims to enhance the quality of care for women, ensuring that their health concerns are prioritized and effectively managed. Through its commitment to ethical standards and patient-centered research, the institution plays a vital role in shaping the future of women's healthcare.

Locations

Dearborn, Michigan, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0