ICS 11.020 CCS C 30 T/GDMDMA 0048—2025团 体 标 准 女性压力性尿失禁尿道中段悬吊手术 应用标准 The application standards for mid-ur ethral sling for female str ess urinary incontinence 2025-06-23 发布          2025 -06-23 实施 广东省医疗器械管理学会 发 布T/GDMDMA 全国团体标准信息平台 全国团体标准信息平台 T/GDMDMA 0048—2025 Ⅰ目 次T/GDMDMA0048—2025 前言 ···························································································································· Ⅲ 引言 ···························································································································· Ⅳ 1 范围 ························································································································· 1 2 规范性引用文件 ········· ································································································· 1 3 术语和定义 ················································································································ 1 4 总则 ························································································································· 1 5 尿道中段悬吊术的适应证及禁忌证 ···································· ·············································· 1 5.1 适应证 ················································································································· 1 5.2 禁忌证 ················································································································· 2 6 术前评估和准备 ··································································································· ······· 2 6.1 术前评估 ·············································································································· 2 6.2 查体 ···················································································································· 2 6.3 非复杂性压力性尿失禁评估 ······················································································ 2 6.4 复杂性压力性尿失禁评估 ···························· ····························································· 2 6.5 压力性尿失禁患者心理评估 ······················································································ 2 6.6 术前病人谈话与知情同意 ························································································· 3 7 手术步骤和注意事项 ···································································································· 3 7.1 经耻骨后路径尿道中段悬 吊术（TVT 术） ····································································· 3 7.2 经闭孔路径尿道中段悬吊术（TVT -O术） ······································································ 3 7.3 手术注意事项 ········································································································ 3 8 手术并发症的预防及处理 ······························································································ 4 8.1 手术并发症的预防 ·································································································· 4 8.2 手术并发症的处理 ·································································································· 4 参考文献 ························································································································ 5 全国团体标准信息平台 T/GDMDMA 0048—2025 Ⅱ全国团体标准信息平台 T/GDMDMA 0048—2025 Ⅲ前   言 本文件按照GB/T 1.1—2020《标准化工作导则 第1部分：标准化文件的结构和起草规则》的规定 起草。 请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别专利的责任。 本文件由中国医学科学院北京协和医院提出。 本文件由广东省医疗器械管理学会归口。本文件起草单位：中国医学科学院北京协和医院、上海市第六人民医院、武汉大学人民医院、江 西省妇幼保健院、重庆市妇幼保健院、解放军总医院第四医学中心、四川大学华西二院、成都市妇女 儿童中心医院、宁夏医科大学总医院、烟台毓璜顶医院、湖北省妇幼保健院、南京市妇幼保健院、山 西省白求恩医院、空军军医大学西京医院、陆军军医大学第一附属医院、哈尔滨医科大学附属第一医 院、郑州大学第三附属医院、大连市妇女儿童医疗中心集团、华中科技大学同济医学院附属协和医院。 本文件主要起草人：朱兰、史宏晖、梁硕、叶扬、曹杨、吴氢凯、洪莉、汪利群、刘禄斌、鲁永 鲜、苗娅莉、何丽、哈 春芳、曲路芸、杜欣、张蕾、刘小春、张潍、王延洲、徐柏、李蕾、陈礼全、 韩璐、沈怡。 全国团体标准信息平台 6T/GDMDMA 0048—2025 Ⅳ  引   言 女性压力性尿失禁（stress urinary incontinence， SUI）是由于腹压增加导致的尿液不自主溢出的中 老年女性常见的疾病，盆底肌锻炼是SUI的一线治疗方法，对于非手术治疗效果不佳或愿意手术的 中重度SUI患者可考虑手术治疗。植入不可吸收合成材料吊带的经阴道无张力尿道中段悬吊术（mid- urethral slings， MUS）为国际公认的一线的治疗SUI术式。与耻骨后尿道固定术（Burch手术）、自体筋 膜悬吊术等传统术式相比，MUS更微创、手术时间更短，术后成功率不差于传统术式。由于经阴道植 入的不可吸收合成材料吊带由生物医用材料加工而成，长期植入体内，因此，为了保证手术的获益高 于潜在风险，制定应用合成吊带的 MUS的合理手术适应证及术后管理是十分重