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Multicenter, randomized trial comparing native vaginal tissue repair and synthetic mesh repair for genital prolapse surgical treatment

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Abstract

Introduction and hypothesis

This trial aimed to compare the outcomes of native vaginal tissue repair versus polypropylene mesh repair for the treatment of severe genital prolapse.

Methods

This multicenter randomized trial included 184 women, with POP-Q stage 3 or 4. They were randomly assigned to undergo surgical treatment using native tissue repair (n = 90) or synthetic mesh repair (n = 94). Native tissue repair surgery was performed according to site-specific defects, including sacrospinous ligament fixation for apical defects. Mesh repair (Prolift™) was performed in accordance with manufacturer recommendations. Hysterectomy was performed in all cases of uterine prolapse. Statistical tests were used to compare between-group and within-group differences before the surgery and at 1-year follow-up. We considered cure to have occurred when the POP-Q point evaluation was equal to or less than 0 and POP-Q point C better than or equal to half the total vaginal length (TVL) after 1 year. The patients answered the Prolapse Quality-of-Life Questionnaire (PQoL) and the Sexual Quotient Female Version (QS-F) questionnaire.

Results

Both groups were homogeneous preoperatively. There were no differences between the groups in operative time, complications or pain. At 1-year follow-up, anatomical cure rates were better in the mesh group in the anterior compartment (p = 0.019). Significant improvement in PQoL scores at 1-year follow up were observed in each group; between-group comparisons of changes in PQoL scores revealed greater improvement in the mesh group.

Conclusion

Both techniques were effective. Anatomical efficacy was superior in the mesh group regarding the anterior compartment; quality of life changes were also greater in the mesh group. Complications were significantly higher in the mesh group.

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Acknowledgements

The authors would like to thank Solange Maria da Silva for her work as trial monitor, Rosangela Ferreira Magalhaes for her work in trial management and distribution of tested materials, and Selma Maria Mena Romeiro Nishimura for administering the questionnaires used by the coordinating center.

Conflict of interest

Johnson & Johnson donated the polypropylene meshes. All the authors declare that Johnson & Johnson had no involvement in the study design, analysis, results, writing or submission of this manuscript.

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Authors and Affiliations

  1. Hospital Universitário da Universidade de São Paulo, R. Luis Martins, 5/ 102, São Paulo, SP, Brazil, 05060-050

    Simone dos Reis Brandão da Silveira & Miriam Goncalves Markos Kawabata

  2. Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil

    Jorge Milhem Haddad, Fernanda Nastri & Edmund Chada Baracat

  3. Universidade Federal de São Paulo, São Paulo, Brazil

    Zsuzsanna Ilona Katalin de Jármy-Di Bella & Claudinei Alves Rodrigues

  4. Irmandade da Santa Casa de Misericórdia de São Paulo, São Paulo, Brazil

    Silvia da Silva Carramão & Antonio Pedro Flores Auge

Authors
  1. Simone dos Reis Brandão da Silveira
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  2. Jorge Milhem Haddad
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  3. Zsuzsanna Ilona Katalin de Jármy-Di Bella
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Correspondence to Simone dos Reis Brandão da Silveira.

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dos Reis Brandão da Silveira, S., Haddad, J.M., de Jármy-Di Bella, Z.I.K. et al. Multicenter, randomized trial comparing native vaginal tissue repair and synthetic mesh repair for genital prolapse surgical treatment. Int Urogynecol J 26, 335–342 (2015). https://doi.org/10.1007/s00192-014-2501-z

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  • DOI: https://doi.org/10.1007/s00192-014-2501-z

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