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评估Axonics调制技术骶神经调节系统治疗排尿和排便功能障碍的效果。

Evaluation of the axonics modulation technologies sacral neuromodulation system for the treatment of urinary and fecal dysfunction.

作者信息

Cohn Joshua A, Kowalik Casey G, Kaufman Melissa R, Reynolds W Stuart, Milam Douglas F, Dmochowski Roger R

机构信息

a Department of Urologic Surgery , Vanderbilt University Medical Center , Nashville , TN , USA.

出版信息

Expert Rev Med Devices. 2017 Jan;14(1):3-14. doi: 10.1080/17434440.2017.1268913. Epub 2016 Dec 11.

Abstract

Sacral neuromodulation (SNM) remains one of the few effective treatments for refractory bladder and bowel dysfunction. However, SNM is associated with frequent need for surgical intervention, in many cases because of a failed battery. A rechargeable SNM system, with a manufacturer-reported battery life of 15 years or more, has entered post-market clinical testing in Europe but has not yet been approved for clinical testing in the United States. Areas covered: We review existing neuromodulation technologies for the treatment of lower urinary tract and bowel dysfunction and explore the limitations of available technology. In addition, we discuss implantation technique and device specifications and programming of the rechargeable SNM system in detail. Lastly, we present existing evidence for the use of SNM in bladder and bowel dysfunction and evaluate the anticipated trajectory of neuromodulation technologies over the next five years. Expert commentary: A rechargeable system for SNM is a welcome technological advance. However surgical revision not related to battery changes is not uncommon. Therefore, while a rechargeable system would be expected to reduce costs, it will not eliminate the ongoing maintenance associated with neuromodulation. No matter the apparent benefits, all new technologies require extensive post-market monitoring to ensure safety and efficacy.

摘要

骶神经调节(SNM)仍然是治疗难治性膀胱和肠道功能障碍的少数有效疗法之一。然而,SNM常常需要进行手术干预,在许多情况下是因为电池失效。一种可充电的SNM系统,制造商报告其电池寿命为15年或更长,已在欧洲进入上市后临床试验,但尚未获美国批准进行临床试验。涵盖领域:我们回顾了用于治疗下尿路和肠道功能障碍的现有神经调节技术,并探讨了现有技术的局限性。此外,我们详细讨论了可充电SNM系统的植入技术、设备规格和编程。最后,我们展示了SNM用于膀胱和肠道功能障碍的现有证据,并评估了未来五年神经调节技术的预期发展轨迹。专家评论:用于SNM的可充电系统是一项受欢迎的技术进步。然而,与电池更换无关的手术翻修并不罕见。因此,虽然可充电系统预计会降低成本,但它不会消除与神经调节相关的持续维护。无论有明显的益处如何,所有新技术都需要广泛的上市后监测以确保安全性和有效性。

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