一项比较无张力阴道吊带术与无张力阴道吊带闭孔术的随机试验：36个月的结果。
A randomized trial comparing tension-free vaginal tape with tension-free vaginal tape-obturator: 36-month results.
作者信息
Palva Kirsi, Rinne Kirsi, Aukee Pauliina, Kivelä Aarre, Laurikainen Eija, Takala Teuvo, Valpas Antti, Nilsson Carl Gustaf
机构信息
Department of Obstetrics and Gynecology, Helsinki University Central Hospital, POB 140 Haartmaninkatu 2, 00029, Helsinki, Finland.
出版信息
Int Urogynecol J. 2010 Sep;21(9):1049-55. doi: 10.1007/s00192-010-1160-y. Epub 2010 May 4.
INTRODUCTION AND HYPOTHESIS
This is a randomized multicenter study comparing two mid-urethra tape procedures, the tension-free vaginal tape (TVT) with the tension-free vaginal tape-obturator (TVT-O) in terms of cure rate and complication rate.
METHODS
Seven Finnish hospitals participated. Power calculations required 130 women in each group to detect a 10% difference in cure rate. A total of 267 underwent the allocated operation. Follow-up was scheduled at 2, 12, 36 and 60 months. A cough stress test was used as an objective outcome measure. Subjective outcome was assessed by five different condition-specific quality of life questionnaires.
RESULTS
At 36 months of follow-up, 96% of the patients were evaluated. Objective cure rate was 94.6% in the TVT group and 89.5% in the TVT-O group (p = 0.131). Subjective cure rates were significant with no difference between the groups.
CONCLUSION
The TVT and the TVT-O are equally effective in the treatment of stress urinary incontinence after 36-month follow-up with no difference in complication rates.
引言与假设
这是一项随机多中心研究，比较两种经尿道中段吊带手术，即无张力阴道吊带术（TVT）和无张力阴道吊带闭孔术（TVT - O）在治愈率和并发症发生率方面的差异。
方法
七家芬兰医院参与了该研究。功效计算表明，每组需要130名女性才能检测出治愈率10%的差异。共有267名患者接受了分配的手术。随访计划安排在术后2个月、12个月、36个月和60个月。采用咳嗽应力试验作为客观结局指标。通过五种不同的特定病情生活质量问卷评估主观结局。
结果
在36个月的随访中，96%的患者接受了评估。TVT组的客观治愈率为94.6%，TVT - O组为89.5%（p = 0.131）。主观治愈率有显著差异，但两组之间无差异。
结论
在36个月的随访中，TVT和TVT - O在治疗压力性尿失禁方面同样有效，并发症发生率无差异。
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