Laparoscopic versus transvaginal mesh surgery in treatment of apical pelvic organ prolapse in women: MESH-study protocol for a randomized controlled trial

Abstract

Lifetime risk for pelvic organ prolapse is 10–13%. As primary surgical treatment hysterectomy has been a common procedure, with or without colporrhaphies. The risk of recurrent apical prolapse is approximately 10%, and mesh surgery is often needed to gain sufficient support for the vaginal apex. Mesh can be inserted laparoscopically, most commonly by performing a colposacropexy (CSP) which is regarded as the gold standard procedure for vaginal apical prolapse, but also transvaginal (TVM) route is possible. According to previous data these two methods are similarly effective for recurrent vaginal apical prolapse; however, more complications are associated with TVM. Comparative data are scarce, and a randomized comparison of laparoscopic CSP with modern lightweight apical “sling-type” TVM is missing. In this study, we will primarily assess the subjective outcome of vaginal bulging and provide information on safety, anatomical results, patient satisfaction, and the cost-effectiveness of the interventions. We study in a randomized, prospective, comparative non-inferiority trial the outcomes of CSP with or without levator fixation and TVM in women with post-hysterectomy vaginal apical prolapse. Participants are allocated to three groups: CSP with apical fixation only, CSP with apical and levator fixation, or TVM. Follow-up is 5 years, with evaluations also at 6 and 12 months. The primary outcome is subjective efficacy, measured by question 3 of the Pelvic Floor Distress Inventory (PFDI-20) regarding vaginal bulging 12 months after surgery. Secondary outcomes include objective efficacy, peri- and postoperative complications, reoperation rate, subjective outcome and cost-effectiveness. Based on power calculations, 94 patients in the TVM group and 187 patients in the pooled CSP group are required to achieve 80% power with a one-sided alpha of 0.025 and a predefined non-inferiority margin of 20 percentage points. Assuming a 10% dropout rate, 318 patients (106 per study arm) will be recruited. Recruitment is ongoing; anticipated completion December 2026. Both CSP and TVM repairs are established techniques for treating vaginal apical prolapse, yet their risk/benefit profile remains uncertain. This randomized controlled study will provide comparative evidence on patient-reported and anatomical outcomes, safety and technical aspects, and cost-effectiveness to support individualized treatment selection. ClinicalTrials.gov (ID: NCT04478747), Registered on 2020-07-01, URL: https://clinicaltrials.gov/ct2/show/NCT04478747 . Ethics approval HUS/110/2020; Institutional research permission HUS/483/2020.