{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T22:14:36Z","timestamp":1792620876509,"version":"4.5.0"},"reference-count":21,"publisher":"American Medical Association (AMA)","issue":"9","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"Importance<\/jats:title>Transvaginal mesh (TVM) can increase the durability of vaginal surgical procedures for pelvic organ prolapse (POP) and may be indicated in certain situations despite concerns about mesh-related complications. In addition, the expense of commercial mesh kits has limited their use. The effectiveness, safety, and cost of a self-cut mesh procedure compared with a commercial mesh-kit procedure for the surgical treatment of women with POP is unclear.<\/jats:p><\/jats:sec>Objective<\/jats:title>To assess the 1-year effectiveness and safety of self-cut titanium-coated polypropylene mesh compared with a precut commercial mesh kit for the transvaginal surgical treatment of women with severe symptomatic POP.<\/jats:p><\/jats:sec>Design, Setting, and Participants<\/jats:title>This multicenter randomized noninferiority clinical trial was conducted at 11 hospitals in 8 provinces of China. A total of 336 women with symptomatic stage 3 to 4 POP were enrolled between January 22, 2018, and November 11, 2019, with follow-up through December 11, 2020.<\/jats:p><\/jats:sec>Interventions<\/jats:title>Participants were randomized to receive a TVM procedure using either self-cut mesh (self-cut mesh group) or a precut commercial mesh kit (mesh-kit group), both of which used the same titanium-coated polypropylene mesh.<\/jats:p><\/jats:sec>Main Outcomes and Measures<\/jats:title>The primary outcome measure was composite surgical success at 1 year, which was defined as the absence of vaginal bulge symptoms, no additional retreatment for POP, and no vaginal prolapse at or beyond the hymen. Secondary outcomes included symptom-specific pelvic floor function and quality-of-life measures as well as perioperative complications, including mesh-related complications and hospitalization costs. Complications were categorized using the Clavien-Dindo system (with grade 1 indicating any deviation from the normal postoperative course but not requiring grade 2-4 interventions; grade 2, need for pharmacological treatment, blood transfusion, and\/or total parenteral nutrition; grade 3, the need for surgical, endoscopic, and\/or interventional radiological procedures; and grade 4, life threatening).<\/jats:p><\/jats:sec>Results<\/jats:title>Among 336 female participants (mean [SD] age, 63.3 [5.9] years; all of Chinese ethnicity), 169 patients were randomized to the self-cut mesh group, and 167 were randomized to the mesh-kit group. Three patients were unavailable for follow-up after 1 year. In the intention-to-treat analysis, 162 women (95.9%) in the self-cut mesh group had outcomes that met the definition of surgical success; this result was noninferior to the surgical success rate observed in the mesh-kit group (146 women [87.4%]; risk difference, 8.5%; 95% CI, 2.2%-14.3%; P<\/jats:italic>\u2009=\u2009.006). The frequency of Clavien-Dindo grade 1 to 3 perioperative complications was not significant between groups (12 of 166 women [7.2%] in the self-cut mesh group vs 20 of 161 women [12.4%] in the mesh-kit group; P<\/jats:italic>\u2009=\u2009.14). Vaginal mesh exposure rates in women examined at 1 year were similar (4 women [2.4%] in the self-cut mesh group vs 8 women [4.8%] in the mesh-kit group; P<\/jats:italic>\u2009=\u2009.23). Median (IQR) total hospitalization costs were $3663.00 ($3258.90-$4495.10) in the self-cut mesh group vs $6144.00 ($5434.90-$7160.20) in the mesh-kit group (P<\/jats:italic>\u2009&lt;\u2009.01), representing savings of $2481.00 (40.4%) with the use of self-cut mesh.<\/jats:p><\/jats:sec>Conclusions and Relevance<\/jats:title>In this clinical trial, the composite surgical success rate of a self-cut mesh procedure was noninferior to that of a commercial mesh-kit procedure using the same titanium-coated polypropylene mesh and reduced hospitalization expenses by 40.4%. These findings suggest that the use of self-cut mesh procedures may be advantageous for the surgical treatment of some women with severe POP, particularly those in countries with low and middle income.<\/jats:p><\/jats:sec>Trial Registration<\/jats:title>ClinicalTrials.gov identifier: NCT03283124<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2022.31869","type":"journal-article","created":{"date-parts":[[2022,9,16]],"date-time":"2022-09-16T15:31:10Z","timestamp":1663342270000},"page":"e2231869","source":"Crossref","is-referenced-by-count":13,"title":["Effectiveness of Self-cut vs Mesh-Kit Titanium-Coated Polypropylene Mesh for Transvaginal Treatment of Severe Pelvic Organ Prolapse"],"prefix":"10.1001","volume":"5","author":[{"given":"Juan","family":"Chen","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, National Clinical Research Center for Obstetric and Gynecologic Diseases, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiajie","family":"Yu","sequence":"additional","affiliation":[{"name":"Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abraham","family":"Morse","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Tufts University School of Medicine, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guangshi","family":"Tao","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jian","family":"Gong","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Wuxi Maternal and Child Health Care Hospital, Wuxi, Jiangsu, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Binan","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Changsha Maternal and Child Health Care Hospital, Changsha, Hunan, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuling","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Gynecology, Foshan Women and Children Hospital, Southern Medical University, Foshan, Guangdong, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gulina","family":"Ababaikeli","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, The First Affiliated Hospital of Xinjiang Medical University, \u00dcr\u00fcmqi, Xinjiang, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiangyang","family":"Jiang","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Shaanxi Provincial People\u2019s Hospital, Xi'an, Shaanxi, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peishu","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, Jinan, Shandong, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaowei","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hatiguli","family":"Nisier","sequence":"additional","affiliation":[{"name":"Department of Gynecology, The People's Hospital of Xinjiang, Uygur, Autonomous Region \u00dcr\u00fcmqi15, Xinjiang, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ping","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Gynecology, West China Second Hospital of Sichuan University, Chengdu, Sichuan, China"},{"name":"Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education, West China Second Hospital of Sichuan University, Chengdu, Sichuan, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"F\u00fcnfgeld","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Klinik Tettnang, Tettnang, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kuanhui","family":"Huang","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City, Taiwan"},{"name":"Department of Obstetrics and Gynecology, Xiamen Chang Gung Memorial Hospital, Xiamen, Fujian, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heping","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, Yale University School of Public Health, New Haven, Connecticut"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xin","family":"Sun","sequence":"additional","affiliation":[{"name":"Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China"},{"name":"NMPA Key Laboratory for Real World Data Research and Evaluation, Hainan, Chengdu, China"},{"name":"Sichuan Center of Technology Innovation for Real World Data, Chengdu, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lan","family":"Zhu","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, National Clinical Research Center for Obstetric and 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FDA takes action to protect women\u2019s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices. News release. April 16, 2019. Accessed August 4, 2022. https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-takes-action-protect-womens-health-orders-manufacturers-surgical-mesh-intended-transvaginal"}],"container-title":["JAMA Network Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/articlepdf\/2796361\/chen_2022_oi_220903_1662670450.69144.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,9,16]],"date-time":"2022-09-16T15:31:13Z","timestamp":1663342273000},"score":1,"resource":{"primary":{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/fullarticle\/2796361"}},"subtitle":["A Multicenter Randomized Noninferiority Clinical Trial"],"short-title":[],"issued":{"date-parts":[[2022,9,16]]},"references-count":21,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2022,9,1]]}},"URL":"https:\/\/doi.org\/10.1001\/jamanetworkopen.2022.31869","relation":{},"ISSN":["2574-3805"],"issn-type":[{"value":"2574-3805","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,9,16]]}}}