Efficacy of Self-Cut Titanium-Coated Polypropylene Mesh Versus Mesh-Kit for Transvaginal Treatment of Severe Pelvic Organ Prolapse: A Multicenter Randomized Non-Inferiority Trial

Background: Transvaginal mesh can increase the durability of surgery for pelvic organ prolapse. However, commercial mesh kits can be expensive. We assessed the efficacy of a much cheaper self-cut titanium-coated polypropylene mesh with a mesh-kit for treating symptomatic pelvic organ prolapse. Methods: We conducted a multicenter, randomized, non-inferiority trial. Patients were randomized to either self-cut mesh or commercial mesh-kit. Patients with symptomatic stage III-IV pelvic organ prolapse were enrolled at 11 centers between January 2018 and November 2019. The primary outcome measure was composite success at one year defined by absence of vaginal bulge symptoms, and no additional re-treatment for POP, and no vaginal prolapse at or beyond the hymen. Secondary outcomes included symptom-specific pelvic floor function and quality of life measures, complications and costs. Findings: A total of 336 participants were randomized. In the intention-to-treat analysis, 95∙9% (162/169) met the definition of surgical success in the self-cut group, which was noninferior to the 87∙4% (146/167) surgical success in the mesh-kit group (risk difference, 8∙5 [95%CI 2∙2 to 14∙3]). The frequency of Clavien-Dindo grade I-III complications were not significant between groups (12 [7∙2%] vs 20 [12∙4%], P=0∙14). Vaginal mesh exposure rates in women examined within 1 year [self-cut group 4/169 (2∙4%) vs mesh-kit group 8/167 (4∙8%)] were similar (P=0∙23). Interpretation: This trial demonstrated that composite surgical success of a self-cut mesh procedure was non-inferior to a commercial mesh-kit procedure using the same mesh. The use of self-cut mesh was effective and safe, while reducing the hospitalization expense by approximately 40%. Clinical Trial Registration Details: Clinicaltrials.gov, NCT03283124. Funding Information: Chinese Academy of Medical Science Initiative for Innovative Medicine(CAMS-2017-12M-1-002). Medstron Medical(shanghai) Co. Ltd, the agent of Tiloop® products in China, provided monetary support for this research including interim meeting and third party (LinkDoc Beijing company) EDC system. Declaration of Interests: We declare no competing interests. Ethics Approval Statement: The study was approved by the Institutional Review Board of Peking Union Medical College Hospital (JS-1278).