目的:胫神经刺激是膀胱过度活动症(OAB)的有效治疗方法,多年来一直被用作面对面的反复治疗选择。本研究的主要目的是评估长期植入式器械的安全性和有效性,以及利用逆行方法将器械(带有集成四极电极的经皮植入式脉冲发生器[pIPG])放置在胫神经的方法(ProtectPNS;UroMedicalCorp.).
方法:通过多次尸体解剖开发了一种新颖的逆行植入技术,以经皮植入慢性,无线,在胫神经处具有集成四极电极的微创pIPG装置(现获UroMedical许可)。被批准为FDAIDE的一部分的概念验证PIPG设备旨在获得难治性OAB受试者的早期经验。在局部麻醉下使用新的逆行方法将pIPG植入办公室,刺激是使用称为发射器的外部无线能量源激活的。最初,设计了一项初步研究,以比较随机接受经皮胫神经刺激(PTNS)或ProtectPNS治疗的受试者的结局.然而,由于目前可用的样本量较小,无法比较两组。因此,本手稿的目的是描述接受ProtectPNS系统植入的受试者的结局.评估12个月的安全性和有效性。
结果:9名受试者参加了随机试验研究;pIPG组5名,PTNS组4名,所有患者均完成了为期13周的主要终点.随后,PTNS组的两名受试者选择交叉并在13周后植入pIPG.描述了接受pIPG植入的七名受试者的结果。没有发现与办公室程序相关的并发症。两个较旧的型号pIPG设备在1周和4周时变得无反应并被更换。报告并解决了6个次要不良事件。受试者报告了急迫性尿失禁(UUI)发作的改善,OAB症状,和生活质量。用pIPG插入的受试者早在1周报告UUI减少50%。
结论:这项初步研究的结果表明,逆行经皮植入pIPG是安全的,微创一期诊疗术治疗急迫性尿失禁相关OAB症状,12个月随访后无明显并发症。未来的研究将需要比较治疗方式之间的结果。
Tibial nerve stimulation is an effective treatment for overactive bladder (OAB) and has been utilized as an in-person recurring session treatment option for many years. The primary objective of this study was to evaluate the safety and efficacy of a long-term implantable device and the method of utilizing a retrograde approach to place the device (a percutaneous implantable pulse generator [pIPG] with integrated quadripolar electrodes) at the tibial nerve (Protect PNS; Uro Medical Corp.).
A novel retrograde implant technique was developed through multiple cadaveric dissections to percutaneously implant a chronic, wireless, minimally invasive pIPG device with integrated quadripolar electrodes (now licensed to Uro Medical) at the tibial nerve. A proof-of-concept pIPG device approved as part of an FDA IDE was designed to gain early experience in subjects with refractory OAB. The pIPG was implanted in the office under local anesthesia using the novel retrograde approach, and stimulation was activated using an external wireless energy source called a transmitter. Initially, a pilot study was designed to compare outcomes in subjects randomized to either percutaneous tibial nerve stimulation (PTNS) or Protect PNS. However, due to the small sample sizes available at this time, it was not possible to compare the two groups. Thus, the purpose of this manuscript is to describe the outcome of subjects who underwent implantation of the Protect PNS system. Twelve-month safety and efficacy were evaluated.
Nine subjects were enrolled in the randomized pilot study; 5 to the pIPG group and 4 to PTNS, and all completed the 13-week primary endpoint. Subsequently, two subjects in the PTNS group chose to cross over and have the pIPG implanted after 13 weeks. Outcomes of the seven subjects who underwent implantation of the pIPG are described. No complications related to the office procedure were noted. Two of the older model pIPG devices became nonresponsive at 1 and 4 weeks and were replaced. Six minor adverse events were reported and resolved. Subjects reported improvement in urge urinary incontinence (UUI) episodes, OAB symptoms, and quality of life. Subjects impanted with a pIPG reported a 50% reduction in UUI as early as 1 week.
Results of this pilot study suggest that retrograde percutaneous implantation of a pIPG is a safe, minimally invasive one-stage office procedure for treatment for urge incontinence related OAB symptoms, without significant complications after 12 months follow-up. Future studies will be required to compare outcomes among treatment modalities.