Laparoscopic Sacrocolpopexy vs Transvaginal Mesh Repair for Advanced Pelvic Organ Prolapse: 1 Year Results of a Multicenter Randomized Study

Abstract

Backgrounds: Laparoscopic sacrocolpopexy is considered the most durable operation for the repair of advanced uterovaginal prolapse. However, there is still disagreement about whether the efficacy and safety of vaginally implanted mesh to address advanced uterovaginal prolapse is comparable to sacrocolpopexy. Our goal was to evaluate the anatomical and subjective outcomes of laparoscopic sacrocolpopexy versus transvaginal mesh in a randomized trial in China. Methods: A multicenter randomized trial was carried out at 6 tertiary hospitals in China. Patients with symptomatic advanced prolapse (stages III-IV) were enrolled. Between January 2013 and June 2014, a total of 100 women were randomized. 40 laparoscopic sacrocolpopexy procedures and 42 transvaginal mesh procedures were performed. Patients were randomized to undergo either laparoscopic sacrocolpopexy or transvaginal mesh. Results: At 1 year, the anatomic success rate was 92.5% in the laparoscopic sacrocolpopexy arm, compared with 83.3% in the transvaginal mesh group (P=0.35). Laparoscopic sacrocolpopexy was associated with better apical support. The laparoscopic sacrocolpopexy group had a longer operative time. Mesh exposures occurred in 2.5% of laparoscopic repairs vs. 2.4% of transvaginal mesh repairs. Conclusion: In a randomized trial, 1-year objective cure rates were not statistically different. However the success rate was 9.2% higher for laparoscopic sacrocolpopexy. The two procedures had comparable mesh exposure rates, and other complications were rare in both groups. Trial registration: clinicaltrials.gov (NCT01762384). The date of registration was Jan 7th, 2013. URL was https://clinicaltrials.gov/ct2/show/NCT01762384?term=NCT01762384&draw=2&rank=1.