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

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.