经阴道闭孔尿道中段吊带术治疗女性压力性尿失禁的长期疗效：E-TOT 随机对照试验
Long-term outcomes of transobturator tapes in women with stress urinary incontinence: E-TOT randomised controlled trial.
机构信息
Urogynaecology, University of Aberdeen, Aberdeen, UK.
出版信息
BJOG. 2017 May;124(6):973-981. doi: 10.1111/1471-0528.14561.
OBJECTIVE
To assess the long-term patient-reported outcomes and adverse events following surgery using transobturator tension-free vaginal tape (TO-TVT).
DESIGN
Postal follow-up of the E-TOT randomised controlled trial (RCT).
SETTING
A tertiary urogynaecology centre in the UK; all procedures took place in 2005-2007.
POPULATION
A total of 341 women were randomised to receive either 'inside-out' TVT-O (Ethicon Inc., Somerville, NJ, USA) or 'outside-in' TOT-ARIS (Coloplast Corp., Minneapolis, MN, USA) procedure.
METHODS
Long-term follow-up (median 9 years) using validated symptom severity and quality-of-life (QoL) questionnaires. Statistical analysis was performed using spss 22.0 and GraphPad statistics 2014.
MAIN OUTCOME MEASURES
The primary outcome was patient-reported success rate, defined as 'very much/much improved' on the Patient's Global Impression of Improvement (PGI-I) scale. Secondary outcomes included impact on women's QoL and sexual function, adverse events, and re-operations for stress urinary incontinence (SUI).
RESULTS
The adjusted response rate was 67.8% and the median follow-up period was 9.2 years. The overall patient-reported success rate was 71.6%, with a further 14% reporting 'improvement', and there was no significant difference between inside-out and outside-in groups (P = 0.76; odds ratio, OR 0.8676; 95% confidence interval, 95% CI 0.4744-1.5865). The success rate showed a significant reduction compared with 1-year results (71.6 versus 80%; P = 0.004), but a clinically insignificant reduction when compared with the 3-year results (71.6 versus 73.1%). A total of 7.96% underwent further continence surgery, the tape extrusion/erosion rate was 4.5%, and groin pain/discomfort was reported in 4.32%, with only 1.4% requiring treatment.
CONCLUSIONS
This is the largest and longest follow-up randomised trial of TO-TVT. TO-TVT is associated with 71.6% patient-reported success rate, 4% groin pain/discomfort, and 8% continence re-operation rate at a median of 9 years follow-up. The success rate is almost stable after 3 years.
TWEETABLE ABSTRACT
The success rate for TO-TVT is 71% at 9 years, and is almost stable after 3 years; 8% required repeat surgery.
目的
评估经闭孔无张力阴道吊带（TO-TVT）手术后的长期患者报告结局和不良事件。
设计
E-TOT 随机对照试验（RCT）的邮寄随访。
设置
英国一家三级泌尿妇科中心；所有手术均于 2005 年至 2007 年进行。
人群
341 名女性被随机分配接受“内翻”TVT-O（Ethicon Inc.，Somerville，NJ，美国）或“外翻”TOT-ARIS（Coloplast Corp.，Minneapolis，MN，美国）手术。
方法
使用经过验证的症状严重程度和生活质量（QoL）问卷进行长期随访（中位数 9 年）。使用 spss 22.0 和 GraphPad statistics 2014 进行统计分析。
主要结局指标
主要结局是患者报告的成功率，定义为患者整体改善印象（PGI-I）量表上的“非常好/好得多”。次要结局包括对女性 QoL 和性功能的影响、不良事件以及压力性尿失禁（SUI）的再次手术。
结果
调整后的应答率为 67.8%，中位随访时间为 9.2 年。总体患者报告成功率为 71.6%，另有 14%报告“改善”，内翻组和外翻组之间无显著差异（P=0.76；优势比，OR 0.8676；95%置信区间，95%CI 0.4744-1.5865）。与 1 年结果相比，成功率显著下降（71.6%对 80%；P=0.004），但与 3 年结果相比，下降幅度较小（71.6%对 73.1%）。共有 7.96%的患者接受了进一步的控尿手术，吊带脱出/侵蚀率为 4.5%，腹股沟疼痛/不适为 4.32%，仅有 1.4%需要治疗。
结论
这是最大和最长时间的 TO-TVT 随机试验随访。TO-TVT 与 71.6%的患者报告成功率、4%的腹股沟疼痛/不适和 8%的控尿手术率相关，中位随访时间为 9 年。3 年后成功率几乎稳定。
推文摘要
TO-TVT 在 9 年时的成功率为 71%，3 年后几乎稳定；8%需要再次手术。
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