Sacral neuromodulation using the standardized tined lead implantation technique with a curved vs a straight stylet: 2-year clinical outcomes and sensory responses to lead stimulation
Sacral neuromodulation using the standardized tined lead implantation technique with a curved vs a straight stylet: 2-year clinical outcomes and sensory responses to lead stimulation
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DOI：
10.1111/bju.14650
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发表时间：
2019-05-01
影响因子：
4.5
通讯作者：
De Wachter, Stefan
中科院分区：
文献类型：
--
作者：
Vaganee, Donald;Kessler, Thomas M.;De Wachter, Stefan
目的评价24个月以上的临床随访资料，比较标准T形导线置入术中曲形和直形针头在接受骶神经调节的患者中的应用。患者和方法我们在2013年8月至2015年6月期间进行了一项单一的三级中心前瞻性研究，研究对象包括40名膀胱过度活动症患者和15名一线治疗难治的非梗阻性尿失禁患者。根据12个月和24个月的意向治疗分析，主要结果是TIND导联手术成功。第二个结果是编程期间最佳电极配置的数量。对数字和分类数据使用普通非参数检验进行统计分析。结果35例患者中，33例(94%)植入弧形导管，13例(65%)植入直形导管(P=0.005)。12个月和24个月的意向处理分析显示，弯曲针状组的成功率分别为94%和91%，而直形针状组的成功率分别为65%和45%(P=0.002和P<；0.001)。在弯曲针刺组中，60%和25%的电极配置被认为是最佳的和差的，而在直针刺组中，分别有40%和37%的电极配置被认为是最佳的和差的(P<；0.001)。结论与直形导管相比，采用标准化的弧形导管植入技术可获得更成功的T形导联操作，2年的随访率更高，电极的最佳配置数目更多。
Objectives To assess clinical follow-up data over 24 months, comparing the use of a curved vs straight stylet in patients undergoing sacral neuromodulation using the standardized tined lead implantation technique. Patients and Methods We conducted a single tertiary-centre, prospective study between August 2013 and June 2015 involving 40 patients with overactive bladder and 15 with non-obstructive urinary retention refractory to first-line treatment. The primary outcome was successful tined lead procedure according to intention-to-treat analyses at 12 and 24 months. The secondary outcome was number of optimal electrode configurations during programming. Statistical analysis was performed using plain non-parametric tests for numerical and categorical data. Results Successful tined lead procedures were achieved in 33 of 35 patients (94%) implanted with the curved stylet compared with 13 of 20 patients (65%) implanted with the straight stylet (P = 0.005). Intention-to-treat analyses at 12 and 24 months showed success rates of 94% and 91%, respectively, in the curved stylet group vs 65% and 45%, respectively, in the straight stylet group (P = 0.002 and P < 0.001). In the curved stylet group, 60% and 25% of the electrode configurations were considered optimal and poor, respectively, vs 40% and 37%, respectively, in the straight stylet group (P < 0.001). Conclusions The use of the standardized implantation technique with the curved stylet led to more successful tined lead procedures, better success rates after 2 years of follow-up and a greater number of optimal electrode configurations when compared to use of the straight stylet.