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Lower exposure rates of partially absorbable mesh compared to nonabsorbable mesh for cystocele treatment: 3-year follow-up of a prospective randomized trial

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Abstract

Introduction and hypothesis

In surgery for pelvic organ prolapse (POP) the use of alloplastic meshes has become common. Among possible complications, mesh exposure is the most frequent problem. It is hypothesized that exposure rates are correlated to mesh weight and the amount of foreign material. Therefore, we conducted a prospective open-label randomized multicenter trial comparing a conventional polypropylene mesh (PP) with a partially absorbable polypropylene mesh (PA) for cystocele treatment.

Methods

A total of 200 patients with POP > stage I were randomized either to a conventional or a partially absorbable mesh. Exposure rates were observed after 3, 12, and 36 months and correlated to mesh material, patient characteristics, intraoperative data, and treatment centers. Furthermore, management of mesh exposure, satisfaction with surgery, and postoperative pain were evaluated.

Results

At all follow-up intervals mesh exposure rate was smaller in the group of the partially absorbable mesh (3 months PP 11.3 % vs PA 3.2 %, p = 0.0492; 12 months 6.6 % vs 6.3 %; 36 months 7.5 % vs 3.4 %). Over the course of time, mesh exposure was observed in 27 patients, with surgical intervention necessary in 11 patients. The rate of recurrent POP was higher (p > 0.05) in patients with the partially absorbable mesh. The majority of patients were fully satisfied with the operation (52.8 %) and had no pelvic floor pain (67.5 %).

Conclusion

In this prospective, randomized trial with a long-term follow-up there was a low exposure rate in both treatment groups with a trend toward fewer exposures in the group of the partially absorbable mesh.

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Abbreviations

POP:

Pelvic organ prolapse

PP:

Conventional nonabsorbable mesh

PA:

Partially absorbable mesh

FDA:

US Food and Drug Administration

ICS:

International Continence Society

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Conflicts of interest

The study was sponsored by Serag Wiessner KG, Naila, Germany. J. Farthmann: consultant for pfm medical; honoraria and travel expenses from Serag Wiessner, Johnson & Johnson, AMI. D. Watermann: travel expenses from Serag Wiessner, AMS and Johnson & Johnson, acceptance of payment for research from Serag Wiessner, consultant for Serag Wiessner, AMS, Johnson & Johnson. A. Niesel: honoraria from Serag Wiessner, BARD, AMS, AMI; consultant for Serag Wiessner, BARD, AMI. C. Fünfgeld: consultant and honoraria from Serag Wiessner, BARD, AMS, AMI, pfm medical, Astellas, Merckle. A. Kraus: honoraria from Serag Wiessner. A. Lenz: honoraria from Serag Wiessner. H. J. Augenstein: consultant for Serag Wiessner. E. Graf: none. B. Gabriel: travel expenses and payment for research from Serag Wiessner.

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Authors and Affiliations

  1. Department of Obstetrics & Gynecology, University Hospitals, Hugstetter Str. 55, 79106, Freiburg, Germany

    J. Farthmann & B. Gabriel

  2. Evangelisches Diakoniekrankenhaus Freiburg, Wirthstr. 11, 79110, Freiburg, Germany

    D. Watermann

  3. Kreiskrankenhaus Preetz, Am Krankenhaus 5, 24211, Preetz, Germany

    A. Niesel

  4. Klinikum Tettnang, Emil-Münch-Straße 16, 88069, Tettnang, Germany

    C. Fünfgeld

  5. Klinikum Fulda, Frauenklinik, Pacelliallee 4, 36043, Fulda, Germany

    A. Kraus

  6. Krankenhaus Hetzelstift, Stiftstraße 10, 67434, Neustadt, Germany

    F. Lenz

  7. Evangelisches Krankenhaus, Frauenklinik, Steinweg 13-17, 26122, Oldenburg, Germany

    H. J. Augenstein

  8. Office of Clinical Studies, University Hospital, Elsässer Str. 2, 79110, Freiburg, Germany

    E. Graf

Authors
  1. J. Farthmann
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  2. D. Watermann
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  3. A. Niesel
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  4. C. Fünfgeld
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  5. A. Kraus
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  8. E. Graf
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  9. B. Gabriel
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Correspondence to J. Farthmann.

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Farthmann, J., Watermann, D., Niesel, A. et al. Lower exposure rates of partially absorbable mesh compared to nonabsorbable mesh for cystocele treatment: 3-year follow-up of a prospective randomized trial. Int Urogynecol J 24, 749–758 (2013). https://doi.org/10.1007/s00192-012-1929-2

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  • DOI: https://doi.org/10.1007/s00192-012-1929-2

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