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脊髓损伤患者神经源性膀胱中无需脊神经切断术的骶神经刺激器植入术:二维手术视频。

Implantation of Sacral Nerve Stimulator Without Rhizotomy for Neurogenic Bladder in Patient With Spinal Cord Injury: 2-Dimensional Operative Video.

机构信息

Department of Neurosurgery, Stanford University, Stanford, California.

Division of Physical Medicine and Rehabilitation, Department of Neurosurgery, University of New Mexico School of Medicine, Albuquerque, New Mexico.

出版信息

Oper Neurosurg (Hagerstown). 2020 Sep 1;19(3):E299. doi: 10.1093/ons/opz429.

Abstract

There are approximately 12 000 new individuals with spinal cord injury (SCI) each year, and close to 200 000 individuals live with a SCI-related disability in the United States. The majority of patients with SCI have bladder dysfunction as a result of their injury, with over 75% unable to void volitionally following their injury. In patients with traumatic SCI, intermittent catheterization is commonly recommended, but a lack of adherence to clean intermittent catheterization (CIC) has been observed, with up to 50% discontinuing CIC within 5 yr of injury. The Finetech Brindley Bladder System (FBBS) is an implantable sacral nerve stimulator for improving bladder function in patients with SCI, avoiding the need for CIC. The FDA-approved implantation (Humanitarian Device Exemption H980008) of the FBBS is combined with a posterior rhizotomy to reduce reflex contraction of the bladder, improving continence. However, the posterior rhizotomy is irreversible and has unwanted effects; therefore, the current FDA-approved implantation is being studied without rhizotomy as part of a clinical trial (Investigational Device Exemption G150201) (ClinicalTrials.gov Identifier: NCT02978638). In this video, we present a case of a 66-yr-old female who presented 40-yr status post-T12 SCI, resulting in complete paraplegia and neurogenic bladder not satisfactorily controlled with CIC. We demonstrate the operative steps to complete the implantation of the device without rhizotomy in the first patient enrolled as part of the clinical trial Electrical Stimulation for Continence After SCI (NCT02978638). Appropriate IRB and patient consent were obtained.

摘要

每年大约有 12000 名新的脊髓损伤(SCI)患者,在美国有近 20 万名患者患有与 SCI 相关的残疾。大多数 SCI 患者都有膀胱功能障碍,超过 75%的患者在受伤后无法自主排空尿液。在创伤性 SCI 患者中,常推荐间歇性导尿,但观察到患者对清洁间歇性导尿(CIC)的依从性较差,多达 50%的患者在受伤后 5 年内停止 CIC。Finetech Brindley 膀胱系统(FBBS)是一种用于改善 SCI 患者膀胱功能的植入式骶神经刺激器,避免了对 CIC 的需求。FBBS 的 FDA 批准植入(人道主义设备豁免 H980008)与后路神经根切断术相结合,可减少膀胱反射性收缩,提高控尿能力。然而,后路神经根切断术是不可逆的,且具有不良影响;因此,目前正在作为临床试验的一部分(调查性设备豁免 G150201)(ClinicalTrials.gov 标识符:NCT02978638),对无神经根切断术的 FBBS 植入进行研究。在这个视频中,我们介绍了一位 66 岁女性的病例,她在 40 年前因 T12 SCI 导致完全截瘫和神经源性膀胱,CIC 不能充分控制,随后出现了这些症状。我们展示了在作为临床试验(NCT02978638)的第一例患者中,在不进行神经根切断术的情况下完成设备植入的手术步骤,该试验为“脊髓损伤后控尿的电刺激(NCT02978638)”。已获得适当的 IRB 和患者同意。

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