TVT-O与单切口吊带TVT SECUR系统治疗压力性尿失禁女性疗效比较的随机试验——2年随访
Randomized trial of a comparison of the efficacy of TVT-O and single-incision tape TVT SECUR systems in the treatment of stress urinary incontinent women--2-year follow-up.
作者信息
Masata Jaromir, Svabik Kamil, Zvara Karel, Drahoradova Petra, El Haddad Rachid, Hubka Petr, Martan Alois
机构信息
Department of Obstetrics and Gynaecology, 1st Medical Faculty, Charles University and General Teaching Hospital, Prague, Czech Republic.
出版信息
Int Urogynecol J. 2012 Oct;23(10):1403-12. doi: 10.1007/s00192-012-1662-x.
INTRODUCTION AND HYPOTHESIS
The aim of this study was to compare the efficacy of the use of tension-free vaginal tape obturator (TVT-O) and single-incision TVT SECUR, hammock and U approach (TVT-S, H and U), in the treatment of urodynamic stress urinary incontinence (SUI).
METHODS
This single-center randomized three-arm trial compared the objective and subjective efficacy and early failure rate of the TVT-O and TVT-S H and U approach by objective criteria (cough test) and subjective criteria using the International Consultation on Incontinence Questionnaire--Short Form (ICIQ-UI SF). The objective efficacy rate was defined as the number of patients with a negative cough stress test. Subjective cure was defined by no stress leakage of urine after surgery based on the evaluation of ICIQ-UI SH (when patients ticked "Never"/"Urine does not leak" in answer to question 6: When does urine leak?). Objective and subjective efficacy were evaluated using Last Failure Carried Forward analysis, i.e., final analysis also included patients with early failure. To describe outcome at different time points, the Last Observation Carried Forward method was also implemented.
RESULTS
One hundred ninety-seven women with proven SUI were randomized into three groups--TVT-O (n = 68), TVT-S H (n = 64), and TVT-S U (n = 65). Each patient allocated to a treatment group received the planned surgery. There were no differences in each group in preoperative characteristics. Median follow-up after surgery was 2 years (SD, 0.8; range, 0.1 to 3.8 years). Of the subjects, 92.6% in the TVT-O group, 68.8% in the TVT-S H group, and 69.2% in the TVT-S U group had negative stress test (p < 0.001). Of the subjects, 85.3 % in the TVT-O group, 68.8% in the TVT-S H group, and 61.5% in the TVT-S U group were subjectively continent (p = 0.02).
CONCLUSIONS
Our study demonstrated a significantly lower subjective and objective cure rate in the single-incision TVT group compared to the TVT-O group.
引言与假设
本研究旨在比较无张力阴道吊带闭孔术（TVT - O）与单切口TVT SECUR、吊床和U形入路（TVT - S、H和U）治疗尿动力学压力性尿失禁（SUI）的疗效。
方法
本单中心随机三臂试验通过客观标准（咳嗽试验）和使用国际尿失禁咨询问卷简表（ICIQ - UI SF）的主观标准，比较了TVT - O和TVT - S H和U形入路的客观和主观疗效及早期失败率。客观有效率定义为咳嗽压力试验阴性的患者数量。主观治愈定义为根据ICIQ - UI SH评估术后无压力性尿漏（当患者在问题6“尿液何时漏出？”的回答中勾选“从不”/“尿液不漏出”时）。使用末次失败结转分析评估客观和主观疗效，即最终分析也包括早期失败的患者。为描述不同时间点的结果，还采用了末次观察结转法。
结果
197例确诊为SUI的女性被随机分为三组——TVT - O组（n = 68）、TVT - S H组（n = 64）和TVT - S U组（n = 65）。分配到治疗组的每位患者均接受了计划的手术。各组术前特征无差异。术后中位随访时间为2年（标准差，0.8；范围，0.1至3.8年）。TVT - O组中92.6%的受试者、TVT - S H组中68.8%的受试者和TVT - S U组中69.2%的受试者咳嗽压力试验为阴性（p < 0.001）。TVT - O组中85.3%的受试者、TVT - S H组中68.8%的受试者和TVT - S U组中61.5%的受试者主观上无尿失禁（p = 0.02）。
结论
我们的研究表明，与TVT - O组相比，单切口TVT组的主观和客观治愈率显著较低。
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