Multicenter, randomized trial comparing native vaginal tissue repair and synthetic mesh repair for genital prolapse surgical treatment

Abstract

Introduction and hypothesis: This trial aimed to compare the outcomes of native vaginal tissue repair versus polypropylene mesh repair for the treatment of severe genital prolapse.

Methods: This multicenter randomized trial included 184 women, with POP-Q stage 3 or 4. They were randomly assigned to undergo surgical treatment using native tissue repair (n = 90) or synthetic mesh repair (n = 94). Native tissue repair surgery was performed according to site-specific defects, including sacrospinous ligament fixation for apical defects. Mesh repair (Prolift™) was performed in accordance with manufacturer recommendations. Hysterectomy was performed in all cases of uterine prolapse. Statistical tests were used to compare between-group and within-group differences before the surgery and at 1-year follow-up. We considered cure to have occurred when the POP-Q point evaluation was equal to or less than 0 and POP-Q point C better than or equal to half the total vaginal length (TVL) after 1 year. The patients answered the Prolapse Quality-of-Life Questionnaire (PQoL) and the Sexual Quotient Female Version (QS-F) questionnaire.

Results: Both groups were homogeneous preoperatively. There were no differences between the groups in operative time, complications or pain. At 1-year follow-up, anatomical cure rates were better in the mesh group in the anterior compartment (p = 0.019). Significant improvement in PQoL scores at 1-year follow up were observed in each group; between-group comparisons of changes in PQoL scores revealed greater improvement in the mesh group.

Conclusion: Both techniques were effective. Anatomical efficacy was superior in the mesh group regarding the anterior compartment; quality of life changes were also greater in the mesh group. Complications were significantly higher in the mesh group.