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Urinary and sexual impact of pelvic reconstructive surgery for genital prolapse by surgical route. A randomized controlled trial

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Abstract

Introduction and hypothesis

The main objective of the study was to evaluate the rates of de novo stress urinary (SUI) and postoperative dyspareunia after both sacrocolpopexy/hysteropexy (SCP) and vaginal mesh surgery.

Methods

A prospective, multicenter, randomized, open-label study with two parallel groups treated by either SCP or Uphold Lite vaginal mesh was carried out. Study participants were ≥ 50 and < 80 years old patients with Pelvic Organ Prolapse Quantification (POP-Q) stage ≥2 who were considered eligible for reconstructive surgery and who were sexually active with no dyspareunia and free from bothersome SUI at presentation. Women were assessed before surgery and at 4–8 weeks and 11–13 months after using validated measures including POP-Q, Pelvic Floor Disability Index (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR), and Patient Global Impression of Improvement (PGI-I). Data were also collected for health economics evaluation.

Results

Of the required sample of 156 women, 42 women (19 SCP and 23 vaginal mesh) were only recruited owing to the discontinuation of vaginal mesh worldwide. The median follow-up was 376 days. The rates of bothersome de novo SUI were similar in the SCP and Uphold vaginal mesh groups (15.79 vs 15.00%, OR 0.95 [95% CI 0.22–4.14]). Among 30 sexually active patients at follow-up, the rates of women reporting de novo dyspareunia “usually or always” were 6.7% after SCP vs 13.3% after vaginal mesh (p = 1). Health economics evaluation showed a cost saving of 280€ in favor of the Uphold vaginal mesh technique, but no significant difference in the total cost (2,934.97€ for SCP vs 3,053.26€ for Uphold vaginal mesh).

Conclusions

Bothersome de novo SUI and de novo dyspareunia occurred in approximately 15% and 23% of our study cohorts, with no significant difference between sacrocolpopexy/hysteropexy and anterior/apical vaginal mesh surgery. However, these results should be interpreted with caution owing to the small sample size.

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Acknowledgements

The authors would like to thank Ms. Pascale Fabbro-Peray for her methodological advice and Ms. Stéphanie Salles for her input in data management. The authors would also like to thank Superviseme Ltd medical writing services (http://www.superviseme.eu) for help with the medical writing and editing of the manuscript.

Funding

Nimes University Hospital, France, and Boston Scientific.

Author information

Authors and Affiliations

  1. Obstetrics and Gynecology Department, CHU Nîmes, University of Montpellier, Place du Pr Robert Debré, 30900, Nîmes, France

    Renaud de Tayrac

  2. Gynecology Department, Jeanne de Flandre Hospital, University of Lille, Lille, France

    Michel Cosson

  3. Gynecology Department, Clinique Beausoleil, Montpellier, France

    Laure Panel

  4. Obstetrics and Gynecology Department, CHU Arnaud de Villeneuve, University of Montpellier, Montpellier, France

    Clara Compan

  5. Department of Biostatistics, Epidemiology, Public Health and Innovation in Methodology (BESPIM), CHU Nîmes, University of Montpellier, Nîmes, France

    Mohammed Zakarya Zemmache & Sophie Bouvet

  6. Urology Department, CHU Nîmes, University of Montpellier, Nîmes, France

    Laurent Wagner

  7. Obstetrics and Gynecology Department, CHU Nîmes, University of Montpellier, Nîmes, France

    Brigitte Fatton

  8. Obstetrics and Gynecology Department, HFME hospital, University of Lyon, Lyon, France

    Géry Lamblin

Authors
  1. Renaud de Tayrac
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  2. Michel Cosson
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  3. Laure Panel
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  4. Clara Compan
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  5. Mohammed Zakarya Zemmache
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  6. Sophie Bouvet
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  7. Laurent Wagner
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  8. Brigitte Fatton
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  9. Géry Lamblin
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Contributions

R. de Tayrac: project development, data collection, data analysis, manuscript editing; G. Lamblin: data collection; M. Cosson: project development, data collection; L. Panel: data collection; C. Compan: data collection; L. Wagner: data collection; Z. Zemmache: data management, data analysis; S. Bouvet: data analysis; B. Fatton: project development.

Corresponding author

Correspondence to Renaud de Tayrac.

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Conflicts of interest

R. de Tayrac, M. Cosson, and B. Fatton are consultants for Boston Scientific. The remaining authors claim no conflicts of interest.

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de Tayrac, R., Cosson, M., Panel, L. et al. Urinary and sexual impact of pelvic reconstructive surgery for genital prolapse by surgical route. A randomized controlled trial. Int Urogynecol J 33, 2021–2030 (2022). https://doi.org/10.1007/s00192-021-05071-8

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  • DOI: https://doi.org/10.1007/s00192-021-05071-8

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