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Related Experiment Video

Updated: Sep 20, 2025

Transvaginal Mesh Insertion in the Ovine Model
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Transvaginal Mesh Compared With Native Tissue Repair for Pelvic Organ Prolapse.

Bruce Kahn1, R Edward Varner, Miles Murphy

  • 1Department of Obstetrics & Gynecology, Scripps Clinic, San Diego, California; Division of Women's Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama; the Institute for Female Pelvic Medicine & Reconstructive Surgery, North Wales, Pennsylvania; the Department of Obstetrics and Gynecology, University of Chicago Pritzker School of Medicine, Chicago, and the Division of Urogynecology, Department of Obstetrics and Gynecology, NorthShore University HealthSystem, Winnetka, Illinois; the American Association of Female Pelvic Medicine Specialists, Inc., Westlake Village, California; the, Department of Family Medicine, University of Southern California, Westlake Village, California; the Division of Female Pelvic Medicine & Reconstructive Surgery, Department of Obstetrics and Gynecology, Cooper University Health Care, Cooper Medical School of Rowan University, Camden, New Jersey; the Department of Urology, Columbia University Irving Medical Center, New York, New York; the Department of Urology, West Chester Hospital, West Chester Township, and the Division of Urology, Department of Surgery, University of Cincinnati College of Medicine Cincinnati, Ohio; and Division of Urogynecology and Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics & Gynecology, School of Medicine, University of California, Irvine, Orange, California.

Obstetrics and Gynecology
|June 8, 2022
PubMed
Summary

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Transvaginal mesh repair was noninferior to native tissue repair for pelvic organ prolapse, showing similar subjective success rates and safety profiles. Mesh repair demonstrated superiority in secondary composite outcomes but not primary ones.

Area of Science:

  • Urogynecology
  • Pelvic Floor Disorders
  • Surgical Innovation

Background:

  • Pelvic organ prolapse (POP) affects many women, with surgical repair options including transvaginal mesh and native tissue repair.
  • The U.S. Food and Drug Administration (FDA) mandated a 522 study to compare the safety and effectiveness of these two POP surgical methods.

Purpose of the Study:

  • To compare the safety and effectiveness of transvaginal mesh (TVM) repair versus native tissue repair (NTR) for pelvic organ prolapse.
  • To assess co-primary endpoints of superiority and noninferiority between TVM and NTR.

Main Methods:

  • A prospective, nonrandomized, multi-center trial involving 710 patients undergoing TVM or NTR for POP.
  • Primary endpoints included composite treatment success (anatomical, subjective, retreatment) and serious adverse events at 36 months.

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  • Propensity score stratification was used to adjust for baseline differences between groups.

    • Main Results:

    • TVM demonstrated noninferiority to NTR for the primary composite success endpoint (89.3% vs. 80.2%), but was not superior (P=.056).
    • TVM showed superiority in a secondary composite endpoint (P=.009).
    • Subjective success rates were similar between groups (92.4% TVM vs. 92.8% NTR), and TVM was noninferior for serious adverse events (3.1% vs. 2.7%).

    Conclusions:

    • Transvaginal mesh repair is not superior to native tissue repair for pelvic organ prolapse at 36 months.
    • Both methods offer high and similar subjective success rates from the patient's perspective.
    • Transvaginal mesh repair is as safe as native tissue repair concerning serious adverse events.