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A 3-month preclinical trial to assess the performance of a new TVT-like mesh (TVTx) in a sheep model

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Abstract

The objective of this study was to evaluate in a sheep model the performance of a new polypropylene mesh (TVTx), which is intended as a less invasive treatment for female stress urinary incontinence. Eight female sheep were used in this study, each one being implanted with eight TVTx samples. At each time-point (weeks 1, 2, 4, and 12) seven TVTx were pulled out, while one TVTx was carefully dissected for histological investigations. One TVTx and one TVT, moreover, were inserted and immediately pulled out for obtaining the initial pullout forces in all sheep. The initial pullout values of TVT and TVTx were overlapping. The pullout forces of TVTx were >5 N (500 g) and increasing from weeks 1 to 12 (p<0.001). Histology revealed good tissue integration of TVTx in the tissue within 12 weeks after implantation. No abnormal histological findings were observed. This data could support the realization of a clinical trial with the TVTx mesh.

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Acknowledgements

All the authors would like to thank Dan Smith and Xin Fu for the precious collaboration they offered to the study. The study was designed and performed in collaboration with ETHICON GmbH.

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Authors and Affiliations

  1. Department of Women’s & Children’s Health Obstetrics & Gynecology, Uppsala University, Uppsala, Sweden

    Masoumeh Rezapour

  2. Department of Oncological and Surgical Sciences, Urology Clinic, University of Padua, Via Giustiniani 2-35128, Padua, Italy

    Giacomo Novara & Walter Artibani

  3. ETHICON GmbH, R&D Europe, Hamburg, Germany

    Peter A. Meier, Joerg Holste & Susanne Landgrebe

Authors
  1. Masoumeh Rezapour
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  2. Giacomo Novara
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  3. Peter A. Meier
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  4. Joerg Holste
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  5. Susanne Landgrebe
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  6. Walter Artibani
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Corresponding author

Correspondence to Walter Artibani.

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Rezapour, M., Novara, G., Meier, P.A. et al. A 3-month preclinical trial to assess the performance of a new TVT-like mesh (TVTx) in a sheep model. Int Urogynecol J 18, 183–187 (2007). https://doi.org/10.1007/s00192-006-0130-x

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  • DOI: https://doi.org/10.1007/s00192-006-0130-x

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