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Trocarless system for mesh attachment in pelvic organ prolapse repair—1-year evaluation

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Abstract

Introduction and hypothesis

EndoFast Reliant™ system is a novel technology for pelvic organ prolapse (POP) repair that attaches mesh directly with metal fasteners.

Methods

This was a prospective multicenter study in 20 women who underwent vaginal POP repair to evaluate safety and efficacy. The patients were followed for 12 months, using POP-Q measures, questionnaires on symptoms (PFDI), and sexual function (FSFI).

Results

No intraoperative complications occurred. Prolapse has been anatomically resolved (< stage 2) in 85% at 1-year follow-up (17/20 patients). Pelvic Floor Distress Inventory (PFDI) scores showed significant improvement for 1 year in symptoms related to prolapse (4.1–0.7, p < 0.001) and bladder (1.4–0.7, p = 0.06) but not to rectum. Female Sexual Function Index (FSFI) scores did not change significantly. One case of mesh exposure was found (5%) and treated conservatively. No migration of fasteners was observed on X-ray.

Conclusions

The EndoFast Reliant™ system was found safe and efficacious. Future studies are needed to evaluate its advantages over techniques using trocars.

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Conflicts of interest

Dr Alcalay is a consultant of Endogun Medical Systems. Dr. Livneh was employed by IBI.

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Chaim Sheba Medical Center, Ramat Gan, 52621, Israel

    Menachem Alcalay

  2. CHRU de Lille, Lille, France

    Michel Cosson & Jean-Philippe Lucot

  3. IBI Israel Biomedical Innovations Ltd., Haogen, Israel

    Miron Livneh

  4. CHU de Caen, Caen, France

    Peter Von Theobald

Authors
  1. Menachem Alcalay
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  2. Michel Cosson
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  3. Miron Livneh
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  4. Jean-Philippe Lucot
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  5. Peter Von Theobald
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Corresponding author

Correspondence to Menachem Alcalay.

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Alcalay, M., Cosson, M., Livneh, M. et al. Trocarless system for mesh attachment in pelvic organ prolapse repair—1-year evaluation. Int Urogynecol J 22, 551–556 (2011). https://doi.org/10.1007/s00192-010-1349-0

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  • DOI: https://doi.org/10.1007/s00192-010-1349-0

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