This prospective comparative cohort study aims to evaluate the safety and efficacy of transvaginal mesh compared to native tissue repair (NTR) in the surgical correction of anterior and apical compartment pelvic organ prolapse (POP) over a 36-month follow-up period.
Prospective comparative cohort study to prove superiority for efficacy and non-inferiority for serious adverse events (SAEs). The setting was 49 sites across the United States, Canada, Europe, and Australia. Women with bothersome POP symptoms indicated for vaginal surgery with POP-Q scores of Ba ≥0 and C≥ -1/2 TVL were included. Interventions included vaginal NTR or single-incision transvaginal mesh based on shared decision making. POP recurrence, the primary efficacy endpoint, was defined as anatomical prolapse beyond the hymenal ring, subjective perception of protrusion or bulge, or retreatment in the target compartment. The primary safety endpoint consisted of the proportion of device and/or procedure-related SAEs in the target compartment. Secondary endpoints included surgical parameters, quality of life, postoperative pain, and sexual function.
POP recurrence rate at 12 months was 13.1% in the Mesh-arm and 11.5% in the NTR-arm (P = 0.44). The primary safety endpoint was met, with the Mesh-arm demonstrating statistically non-inferior outcomes compared to the NTR-arm in the incidence of device and/or procedure-related SAEs in the target compartment through 12 months (P < 0.01). At 36-months, the surgical POP recurrence rate was 26.7% in the Mesh-arm and 27.0% in the NTR-arm.
At 12- and 36-month follow-up, transvaginal mesh was not superior, but non-inferior in terms of efficacy and safety when compared to native tissue repair for patients with combined anterior and apical compartment prolapse.
Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC. 2024 Sep 09 [Epub ahead of print]
Eric R Sokol, Le Mai Tu, Sherry L Thomas, Ty B Erickson, Jan-Paul W R Roovers
Urogynecology and Pelvic Reconstructive Surgery, Stanford University School of Medicine, Stanford, CA, USA., Division of Urology, Department of Surgery, University of Sherbrooke, Sherbrooke, Quebec, Canada., Department of Family Medicine, University of Southern California, Los Angeles, CA, USA., Division of Urogynecology, Kirk Kevorkian School of Medicine, Las Vegas, NV, USA., Amsterdam UMC, University of Amsterdam, Department of Obstetrics and Gynaecology, Amsterdam Reproduction and Development Research Institute, Amsterdam, The Netherlands. Electronic address: .