Posterior mesh fixation versus non-fixation in sacrocolpopexy: A randomized clinical trial

Abstract

Introduction

Urogenital prolapse affects up to 50% of women, and its treatment is essential for improving quality of life. Laparoscopic sacrocolpopexy is considered the gold standard, but there is no consensus on the optimal surgical approach. This study tests the hypothesis that the absence of posterior mesh fixation is non-inferior to its fixation.

Materials and Methods

We conducted a randomized, single-blinded, monocentric, non-inferiority trial in Italy (NCT04358978). In Group A, the posterior mesh was placed without fixation, while in Group B, it was fixed to the rectovaginal fascia and levator ani muscle. The primary outcome was the correction of prolapse, with secondary outcomes including intraoperative parameters, postoperative characteristics, and urogenital prolapse correction at 1, 6 and 12, months, as well as long-term morbidity.

Results

120 women were randomized into two groups with no significant differences. At 12 months, both groups reported no bulge symptoms, and pelvic pain was 3,3 %. Urinary dysfunction decreased in both groups, with a reduction in de novo incontinence (Group A: 1.6 %, Group B: 3.3 %) and persistent incontinence (Group A: 0 %, Group B: 7 %). Persistent constipation at 12 months was 3.3 % in Group A and 13 % in Group B. No cases of obstructed defecation or mesh erosion were observed. Five cases of failure (8.3 %) were reported in both groups, defined as Ba point reaching the hymen.

Conclusions

The absence of posterior mesh fixation is non-inferior to fixation in laparoscopic sacrocolpopexy in terms of treatment success and postoperative complications.