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

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.