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Improvement of pelvic floor-related quality of life and sexual function after vaginal mesh implantation for cystocele: primary endpoint of a prospective multicentre trial

  • General Gynecology
  • Published:
Archives of Gynecology and Obstetrics Aims and scope Submit manuscript

Abstract

Purpose

Pelvic organ prolapse (POP) impairs quality of life (QoL) due to vaginal bulge symptoms and changes in bladder/bowel and sexual function. The effect of alloplastic meshes on QoL is still being discussed. The purpose of this study was to prospectively evaluate the effect of mesh implantation on QoL and sexual function over 1 year.

Methods

289 women with cystocele > stage I were included in this prospective multicenter study, with nine hospitals participating (ClinicalTrials.gov NCT01084889). Mesh exposures rates and pelvic floor-related QoL using the validated German version of the p-QoL questionnaire were evaluated as the primary endpoints. Based on a single-sided binominal test with α = 0.05 and a power of 0.80, a sample size of 225 for the mesh exposures was calculated. The mesh used was a 6-arm mesh with titanium coating (TILOOP® Total 6, sponsor pfm medical ag, Germany). Preoperative data were compared to 6 and 12 months postoperative data, using Wilcoxon test.

Results

The mean age of the patients was 67 years (min 43, max 87). All domains of QoL improved significantly compared after surgery: mean prolapse score dropped from 73.7 to 19.4 after 6 and 16.2 after 12 months (p < 0.001). Sexual function also improved significantly. The rate of dyspareunia was lower at follow-up.

Conclusions

In this prospective trial, a significant positive effect of mesh implantation on pelvic floor-related QoL was observed. These findings remained stable 1 year after surgery with further improvement. This trial adds further data to the ongoing discussion on the role and risk of meshes in POP surgery.

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Abbreviations

POP:

Pelvic organ prolapse

QoL:

Quality of life

FDA:

US food and drug administration

eCRF:

Electronic case report form

MCID:

Minimal clinically important difference

POP-Q:

Pelvic organ prolapse quantification system

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Acknowledgments

We thank Mr. Arim Shukri for the statistical analysis and Mr. Lutz Sternfeld for the external monitoring.

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology, University Medical Center, Hugstetterstr. 55, 79106, Freiburg, Germany

    Juliane Farthmann

  2. Department of Obstetrics and Gynecology, Klinikum Oberlausitzer Bergland, Zittau, Germany

    Mathias Mengel

  3. Department of Obstetrics and Gynecology, St. Elisabeth-Krankenhaus, Leipzig, Germany

    Birgit Henne

  4. Department of Obstetrics and Gynecology, Staedtisches Klinikum Friedrichstadt, Dresden, Germany

    Markus Grebe

  5. Department of Obstetrics and Gynecology, Evangelisches Diakoniekrankenhaus, Freiburg, Germany

    Dirk Watermann

  6. Department of Obstetrics and Gynecology, Klinikum Ludwigsburg, Ludwigsburg, Germany

    Jan Kaufhold

  7. Department of Obstetrics and Gynecology, Klinik Tettnang, Tettnang, Germany

    Margit Stehle & Christian Fuenfgeld

Authors
  1. Juliane Farthmann
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  2. Mathias Mengel
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  6. Jan Kaufhold
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  7. Margit Stehle
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  8. Christian Fuenfgeld
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Corresponding author

Correspondence to Juliane Farthmann.

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Funding

The study was sponsored by pfm medical ag, Cologne, Germany.

Conflict of interest

We have had full control of all primary data and agree to allow the Journal to review our data if requested.

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Farthmann, J., Mengel, M., Henne, B. et al. Improvement of pelvic floor-related quality of life and sexual function after vaginal mesh implantation for cystocele: primary endpoint of a prospective multicentre trial. Arch Gynecol Obstet 294, 115–121 (2016). https://doi.org/10.1007/s00404-016-4014-0

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  • DOI: https://doi.org/10.1007/s00404-016-4014-0

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