{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T13:21:40Z","timestamp":1740144100150,"version":"3.37.3"},"reference-count":12,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2020,2,26]],"date-time":"2020-02-26T00:00:00Z","timestamp":1582675200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2020,2,26]],"date-time":"2020-02-26T00:00:00Z","timestamp":1582675200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Chinese academy of medical science","award":["(CAMS-2017-12M-1-002)"],"award-info":[{"award-number":["(CAMS-2017-12M-1-002)"]}]},{"name":"Medstron Medical(shanghai) Co. Ltd","award":["NA"],"award-info":[{"award-number":["NA"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2020,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n<jats:title>Background<\/jats:title>\n<jats:p>Pelvic organ prolapse (POP) is a common health problem and has significant negative effects on a woman\u2019s quality of life. The transvaginal mesh procedure is a durable reconstructive surgery, but the mesh kits are expensive for underdeveloped countries. Our previous case-series study showed that the use of self-cut mesh had a good success rate (91.8% at 1-year follow-up) and low complication rate. This trial is designed to compare a self-cut titanium-coated polypropylene mesh procedure with a mesh kit for the treatment of symptomatic stage III\u2013IV anterior or apical prolapse in terms of efficacy, safety and cost-effectiveness.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Methods<\/jats:title>\n<jats:p>The trial is a randomized controlled multicenter non-inferiority trial. The primary outcome measure is the composite success rate at 1-year follow-up. The secondary outcomes are anatomic outcomes of each vaginal segment (anterior, posterior and apical) using the POP-Q score, subjective improvement of quality of life according to questionnaires, intraoperative parameters, complications and costs. Analysis will be performed according to the intention-to-treat principle. Based on a comparable success rate of 90% and 10% as the margin (\u03b2 = 0.2 and one-sided \u03b1 = 0.025), about 312 patients in total from 11 centers will be recruited including 10% dropout. The aims of the research are to demonstrate whether the self-cut mesh procedure is non-inferior to the mesh-kit procedure and to investigate the performance of titanium-coated mesh for vaginal prolapse repair.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Discussion<\/jats:title>\n<jats:p>This multicenter non-inferiority trial will evaluate whether the efficacy and safety of self-cut mesh is non-inferior to mesh kits in women with severe symptomatic stage III\u2013IV anterior or apical prolapse. If we are able to show that the self-cut mesh procedure is non-inferior to the mesh-kit procedure in success rates, then the self-cut mesh procedure may be more cost-effective.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Trial registration<\/jats:title>\n<jats:p>ClinicalTrials.gov, <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT03283124\">NCT03283124<\/jats:ext-link>. Registered on 17 January 2018.<\/jats:p>\n<\/jats:sec>","DOI":"10.1186\/s13063-019-3966-3","type":"journal-article","created":{"date-parts":[[2020,2,26]],"date-time":"2020-02-26T19:02:52Z","timestamp":1582743772000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Self-cut titanium-coated polypropylene mesh versus pre-cut mesh-kit for transvaginal treatment of severe pelvic organ prolapse: study protocol for a multicenter non-inferiority trial"],"prefix":"10.1186","volume":"21","author":[{"given":"Juan","family":"Chen","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jiajie","family":"Yu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abraham","family":"Morse","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian","family":"F\u00fcnfgeld","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kuanhui","family":"Huang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jian","family":"Gong","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Guangshi","family":"Tao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Binan","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuling","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiangyang","family":"Jiang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gulina","family":"Ababaikeli","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peishu","family":"Liu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hatiguli","family":"Nisier","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiaowei","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ping","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xin","family":"Sun","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5753-5426","authenticated-orcid":false,"given":"Lan","family":"Zhu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2020,2,26]]},"reference":[{"issue":"6","key":"3966_CR1","doi-asserted-by":"publisher","first-page":"558","DOI":"10.1080\/13697137.2016.1240771","volume":"19","author":"RM Islam","year":"2016","unstructured":"Islam RM, Bell RJ, Billah B, Hossain MB, Davis SR. The prevalence of symptomatic pelvic floor disorders in women in Bangladesh. Climacteric. 2016;19(6):558\u201364.","journal-title":"Climacteric."},{"issue":"1","key":"3966_CR2","doi-asserted-by":"publisher","first-page":"141","DOI":"10.1097\/AOG.0000000000000057","volume":"123","author":"JM Wu","year":"2014","unstructured":"Wu JM, Vaughan CP, Goode PS, Redden DT, Burgio KL, Richter HE, Markland AD. Prevalence and trends of symptomatic pelvic floor disorders in U.S. women. Obstet Gynecol. 2014;123(1):141\u20138.","journal-title":"Obstet Gynecol"},{"issue":"11","key":"3966_CR3","doi-asserted-by":"publisher","first-page":"1085","DOI":"10.1016\/j.jogc.2017.05.006","volume":"39","author":"M Larouche","year":"2017","unstructured":"Larouche M, Geoffrion R, Walter JE. No. 351-Transvaginal Mesh Procedures for Pelvic Organ Prolapse. J Obstet Gynaecol Can. 2017;39(11):1085\u201397.","journal-title":"J Obstet Gynaecol Can"},{"issue":"9","key":"3966_CR4","first-page":"647","volume":"49","author":"Urogynecology Subgroup, Chinese Society of Obstetrics and Gynecology, Chinese Medical Association; Urogynecology Subgroup Chinese Society of Obstetrics and Gynecology Chinese Medical Association","year":"2014","unstructured":"Urogynecology Subgroup, Chinese Society of Obstetrics and Gynecology, Chinese Medical Association; Urogynecology Subgroup Chinese Society of Obstetrics and Gynecology Chinese Medical Association. Guideline for the diagnosis and management of pelvic organ prolapse (draft). Zhonghua Fu Chan Ke Za Zhi. 2014;49(9):647\u201351.","journal-title":"Zhonghua Fu Chan Ke Za Zhi"},{"issue":"3","key":"3966_CR5","doi-asserted-by":"publisher","first-page":"328","DOI":"10.1097\/gme.0b013e3181f083ae","volume":"18","author":"L Zhu","year":"2011","unstructured":"Zhu L, Lang J, Sun Z, Ren C, Liu X, Li B. Pelvic reconstruction with mesh for advanced pelvic organ prolapse: a new economic surgical method. Menopause. 2011;18(3):328\u201332.","journal-title":"Menopause."},{"issue":"6S","key":"3966_CR6","doi-asserted-by":"publisher","first-page":"S245","DOI":"10.1016\/j.jmig.2015.08.856","volume":"22","author":"L Zhu","year":"2015","unstructured":"Zhu L, Zhang L, Xu T, Lang J. Long-term outcomes of the self-cut mesh-related modified total pelvic reconstructive surgical repair for pelvic organ prolapse in China: a 7-year prospective cohort study. J Minim Invasive Gynecol. 2015;22(6S):S245.","journal-title":"J Minim Invasive Gynecol"},{"issue":"8","key":"3966_CR7","first-page":"564","volume":"46","author":"ZJ Sun","year":"2011","unstructured":"Sun ZJ, Zhu L, Lang JH, Hua KQ, Yang X, Han JS, Liang ZQ, Hu LN, Wang JL, Ma L. Prospective multi-center study in \u201cXiehe\u201d pelvic floor reconstruction surgery for severe pelvic organ prolapse. Zhonghua Fu Chan Ke Za Zhi. 2011;46(8):564\u20139.","journal-title":"Zhonghua Fu Chan Ke Za Zhi"},{"issue":"1","key":"3966_CR8","doi-asserted-by":"publisher","first-page":"115","DOI":"10.1007\/s00404-016-4014-0","volume":"294","author":"J Farthmann","year":"2016","unstructured":"Farthmann J, Mengel M, Henne B, Grebe M, Watermann D, Kaufhold J, Stehle M, Fuenfgeld C. Improvement of pelvic floor-related quality of life and sexual function after vaginal mesh implantation for cystocele: primary endpoint of a prospective multicentre trial. Arch Gynecol Obstet. 2016;294(1):115\u201321.","journal-title":"Arch Gynecol Obstet"},{"key":"3966_CR9","doi-asserted-by":"publisher","first-page":"993","DOI":"10.1055\/s-0043-116857","volume":"77","author":"C F\u00fcnfgeld","year":"2017","unstructured":"F\u00fcnfgeld C, Stehle M, Henne B, Kaufhold J, Watermann D, Grebe M, Mengel M. Quality of life, sexuality, anatomical results and side-effects of implantation of an alloplastic mesh for cystocele correction at follow-up after 36 months. Geburtsh Frauenheilk. 2017;77:993\u20131001.","journal-title":"Geburtsh Frauenheilk"},{"issue":"2","key":"3966_CR10","first-page":"181","volume":"34","author":"AI Fang-fang","year":"2018","unstructured":"Fang-fang AI, Lan ZHU, Zhi-jing SUN, Juan CHEN, Hong-hui SHI, Jing-he LANG. Short-term effects of application of titanized polypropylene lightweight mesh in modified total pelvic floor reconstruction. Zhongguo Shi Yong Fu Ke Yu Chan Ke Za Zhi. 2018;34(2):181\u20135.","journal-title":"Zhongguo Shi Yong Fu Ke Yu Chan Ke Za Zhi"},{"issue":"9","key":"3966_CR11","doi-asserted-by":"publisher","first-page":"1030","DOI":"10.1097\/gme.0b013e31820fbcbe","volume":"18","author":"L Zhu","year":"2011","unstructured":"Zhu L, Yu S, Xu T, Yang X, Lu Y, Li B, Lang J. Chinese validation of the Pelvic Floor Impact Questionnaire short form. Menopause. 2011;18(9):1030\u20133.","journal-title":"Menopause."},{"issue":"2","key":"3966_CR12","doi-asserted-by":"publisher","first-page":"117","DOI":"10.1016\/j.ijgo.2011.08.021","volume":"116","author":"L Zhu","year":"2012","unstructured":"Zhu L, Yu S, Xu T, Yang X, Lu Y, Lang J. Validation of the Chinese version of the Pelvic Organ Prolapse\/Urinary Incontinence Sexual Questionnaire short form (PISQ-12). Int J Gynaecol Obstet. 2012;116(2):117\u20139.","journal-title":"Int J Gynaecol Obstet"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-019-3966-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1186\/s13063-019-3966-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-019-3966-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,2,25]],"date-time":"2021-02-25T00:25:05Z","timestamp":1614212705000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-019-3966-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,2,26]]},"references-count":12,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2020,12]]}},"alternative-id":["3966"],"URL":"https:\/\/doi.org\/10.1186\/s13063-019-3966-3","relation":{},"ISSN":["1745-6215"],"issn-type":[{"type":"electronic","value":"1745-6215"}],"subject":[],"published":{"date-parts":[[2020,2,26]]},"assertion":[{"value":"24 January 2019","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"6 December 2019","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"26 February 2020","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"The study protocol and informed consent was approved by the institutional review board of Peking Union Medical College Hospital (JS-1278). The written informed consent will be obtained and documented for all study participants.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"The authors declare that they agree with publication.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"226"}}