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Randomized Controlled Trial
. 2022 Jul;33(7):2021-2030.
doi: 10.1007/s00192-021-05071-8. Epub 2022 Jan 19.

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

Renaud de Tayrac  1 , Michel Cosson  2 , Laure Panel  3 , Clara Compan  4 , Mohammed Zakarya Zemmache  5 , Sophie Bouvet  5 , Laurent Wagner  6 , Brigitte Fatton  7 , Géry Lamblin  8
Affiliations
Randomized Controlled Trial

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

Renaud de Tayrac et al. Int Urogynecol J. 2022 Jul.

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.

Keywords: Dyspareunia; Mesh; POP; Pelvic organ prolapse; Sacrocolpopexy; Sacrohysteropexy; Sexual function; Urinary incontinence.

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References

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