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Comparison between trans-obturator trans-vaginal mesh and traditional anterior colporrhaphy in the treatment of anterior vaginal wall prolapse: results of a French RCT

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Abstract

Introduction and hypothesis

To compare the efficacy of a collagen-coated polypropylene mesh and anterior colporrhaphy in the treatment of stage 2 or more anterior vaginal wall prolapse.

Methods

Prospective, randomized, multicenter study conducted between April 2005 and December 2009. The principal endpoint was the recurrence rate of stage 2 or more anterior vaginal wall prolapse 12 months after surgery. Secondary endpoints consisted of functional results and mesh-related morbidity.

Results

One hundred and forty-seven patients were included, randomized and analyzed: 72 in the anterior colporrhaphy group and 75 in the mesh group. The anatomical success rate was significantly higher in the mesh group (89 %) than in the colporrhaphy group (64 %) (p = 0.0006). Anatomical and functional recurrence was also less frequent in the mesh group (31.3 % vs 52.2 %, p = 0.007). Two patients (2.8 %) were reoperated on in the colporrhaphy group for anterior vaginal wall prolapse recurrence. No significant difference was noted regarding minor complications. An erosion rate of 9.5 % was noted. De novo dyspareunia occurred in 1/14 patients in the colporrhaphy group and in 3/13 patients in the mesh group. An analysis of the quality of life questionnaires showed an overall improvement in both groups, with no statistical difference between them. Satisfaction rates were high in both groups (92 % in the colporrhaphy group and 96 % in the mesh group).

Conclusion

Trans-obturator Ugytex® mesh used to treat anterior vaginal wall prolapse gives better 1-year anatomical results than traditional anterior colporrhaphy, but with small a increase in morbidity in the mesh group.

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Acknowledgements

The study was funded by The Department of Clinical Research of Paris-Ile-de-France (Project n°P040306-CRC04001). Sofradim corporation provided partial funding for meshes, data management, and data analysis. We are indebted to all investigators: N. Aflak, B. Deval, X. Deffieux, C. Frayret, B. Fatton, B. Jacquetin, P. Ferry, P. Costa, P. Mares, L. Wagner, C. Courtieu, V. Descheemaeker, P.L. Broux, J. Blanchot, F. Sergent, L. Marpeau and M.C. Anton-Bousquet. We also wish to thank the members of BESPIM for data management and statistical analysis (especially P. Fabbro-Peray).

Financial disclaimer/conflicts of interest

R .de Tayrac is consultant for Boston Scientific, has had research funding from Sofradim-Covidien, Boston-Scientific, and has accepted speaker’s fees from Boston Scientific, Coloplast, and American Medical System. G. Eglin has acted as a consultant for Sofradim. H. Fernandez is a consultant for American Medical System. A. Cornille, O. Guilbaud, A. Mansoor, and S. Alonso have no conflict of interest to declare.

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Caremeau University Hospital, Nimes, France

    R. de Tayrac & A. Cornille

  2. Department of Gynecology, Clinique Champeau, Beziers, France

    G. Eglin

  3. Department of Obstetrics and Gynecology, Chartres Hospital, Chartres, France

    O. Guilbaud

  4. Department of Obstetrics and Gynecology, Issoire Hospital, Issoire, France

    A. Mansoor

  5. Department of Biostatistics, Caremeau University Hospital, Nimes, France

    S. Alonso

  6. Department of Obstetrics and Gynecology, Kremlin Bicêtre University Hospital, Kremlin Bicêtre, France

    H. Fernandez

  7. Service de Gynécologie-Obstétrique, Hôpital Carémeau, Place du Professeur Robert Debré, 30029, Nimes Cedex 9, France

    R. de Tayrac

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  1. R. de Tayrac
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Correspondence to R. de Tayrac.

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de Tayrac, R., Cornille, A., Eglin, G. et al. Comparison between trans-obturator trans-vaginal mesh and traditional anterior colporrhaphy in the treatment of anterior vaginal wall prolapse: results of a French RCT. Int Urogynecol J 24, 1651–1661 (2013). https://doi.org/10.1007/s00192-013-2075-1

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  • DOI: https://doi.org/10.1007/s00192-013-2075-1

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