The Impact of Transvaginal Meshes on Sexual Function– the Provis Study

Abstract

Introduction and Hypothesis: Due to a potential risk of de novo dyspareunia, transvaginal meshes (TVM) are mainly used in postmenopausal women and in case of recurrent prolapse. Partially absorbable TVM are based on a highly flexible macroporous polypropylene of which half is absorbed within 84 days. These meshes have been assumed to affect sexual experiencing less than conventional TVM do. Therefore, we hypothesized that there is no worsening in vita sexualis after implantation of this product. Methods: We conducted a prospective single-arm multicentre post-marketing study with intrapersonal comparison. Prolapse was quantified by ICS-Pelvic organ prolapse quantification system (POPQ). Patients filled in the validated German versions of the Female Sexual Function Index Questionnaire (FSFI-d) and the Pelvic Floor Questionnaire (PFQ) before and 12 months after mesh implantation. Twelve months after surgery patients were interviewed on their level of satisfaction with the operation by a Visual Analog Scale (VAS), the Patient Global Impression (PGI) question and the question whether they would undergo that procedure again. Patient accrual was closed after11 patients due to the withdrawal of the product from the market. Results: Postoperative FSFI-d total score showed not only non-inferiority but even superiority compared to baseline. FSFI-d subscore pain also disproved non-inferiority and showed a tendency towards superiority. All PFQ subscores improved 12 months after surgery. Patient satisfaction was high. Conclusions: Despite the lack of statistical power, there was no worsening of sexual experiencing following implantation of TVM.