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用于局部麻醉下经皮植入的新型骶神经调节电极:描述与首次经验

New sacral neuromodulation lead for percutaneous implantation using local anesthesia: description and first experience.

作者信息

Spinelli Michele, Giardiello Gianluca, Gerber Martin, Arduini Andrea, van den Hombergh Ubi, Malaguti Silvia

机构信息

Ospedale Fornaroli, Magenta, Via Vittadini 21, 20136 Milan, Italy.

出版信息

J Urol. 2003 Nov;170(5):1905-7. doi: 10.1097/01.ju.0000092634.64580.9a.

DOI:10.1097/01.ju.0000092634.64580.9a
PMID:14532804
Abstract

PURPOSE

In functional urology today chronic stimulation of the sacral nerves has become one of the most accepted methods of stimulation treatment. Many studies have described the advantage of test stimulation prior to implanting the definitive system to enable effective patient selection. We studied a method aimed at improving lead anchoring by developing a self-blocking electrode with a simple placement procedure, in the process creating a 2-stage approach to full percutaneous implantation that allows a long screening period during the first temporary stimulation stage.

MATERIALS AND METHODS

A new tined lead was specifically designed to allow minimally invasive percutaneous lead placement requiring no incision and no additional fascial anchoring. From September 2001 to November 2002, 15 consecutive patients (3 males and 12 females) 27 to 70 years old (mean age 49) underwent this procedure and were prospectively evaluated. No PNE test was performed.

RESULTS

Following the first stage screening phase 12 patients were implanted with the implantable pulse generator (IPG), while 3 who did not respond positively to test stimulation (neurogenic voiding dysfunction, urge incontinence and neurogenic urge incontinence in 1 each) did not undergo IPG implantation and had the tined lead removed under local anesthesia. We did not observe any lead displacement during the screening period (average 38.8 days) or during followup of IPG implanted cases (average 11 months, range 5 to 19).

CONCLUSIONS

Our results show that the new tined anchoring system is a reliable way to allow truly minimally invasive placement of the chronic lead.

摘要

目的

在当今的功能性泌尿外科中,骶神经慢性刺激已成为最被广泛接受的刺激治疗方法之一。许多研究都描述了在植入最终系统之前进行测试刺激的优势,以便能够有效地选择患者。我们研究了一种方法,旨在通过开发一种具有简单放置程序的自锁定电极来改善电极固定,在此过程中创建了一种两阶段的完全经皮植入方法,该方法在第一个临时刺激阶段允许较长的筛查期。

材料与方法

专门设计了一种新的带倒刺电极,以允许进行微创经皮电极放置,无需切口且无需额外的筋膜固定。从2001年9月至2002年11月,连续15例年龄在27至70岁(平均年龄49岁)的患者(3例男性和12例女性)接受了该手术,并进行了前瞻性评估。未进行阴部神经体感诱发电位(PNE)测试。

结果

在第一阶段筛查期后,12例患者植入了植入式脉冲发生器(IPG),而3例对测试刺激无阳性反应的患者(分别为神经源性排尿功能障碍、急迫性尿失禁和神经源性急迫性尿失禁各1例)未进行IPG植入,并在局部麻醉下取出了带倒刺电极。在筛查期(平均38.8天)或IPG植入病例的随访期(平均11个月,范围5至19个月)内,我们未观察到任何电极移位情况。

结论

我们的结果表明,新的带倒刺固定系统是一种可靠的方法,可实现慢性电极的真正微创放置。

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