A multicenter, randomized trial comparing pelvic organ prolapse surgical treatment with native tissue and synthetic mesh: A 5-year follow-up study.

ABSTRACT

INTRODUCTION: The aim of this study was to compare long-term outcomes in patients who underwent either native tissue repair or monofilament macroporous polypropylene mesh. METHODS: This multicenter, randomized trial included-at the end of 5 years follow-up-122 women with severe pelvic organ prolapse, who were randomly assigned to undergo surgical treatment using native tissue repair (native tissue group, n = 59) or synthetic mesh repair (mesh group, n = 63). Cure criterion was when pelvic organ prolapse-quantification (POP-Q) point was ≤0. Quality of life was assessed using the prolapse quality-of-life questionnaire and sexual function with the quality of sexual function. RESULTS: Groups were homogeneous preoperatively with the exception of the previous pelvic surgery variable, which was higher in mesh (P = .019). Cure rate was significantly better for mesh group in the anterior compartment (P = .002) and in the combination of all compartments (P = .001). Native tissue group was significantly better when there was prolapse in the posterior and apical compartment (P = .031). In the quality of life analysis, mesh group showed a significant improvement compared with native tissue group (P = .004). Complications were significantly higher in mesh and recurrence in native tissue. Regarding the reoperation rate, there was no difference between groups, but native tissue had a higher reoperation rate due to recurrence (P = .031). CONCLUSIONS: Outcomes in women with severe POP were better with mesh use than native tissue repair, both in the anterior compartment and in the multicompartmental prolapse after 5-year follow-up. Complications were more common in the mesh group and recurrences were more frequent in the native tissue group.