Pudendal Nerve Block Neural Prosthesis

阴部神经阻滞神经假体

• 批准号: 8251269
• 负责人: Kenneth J. Gustafson
• 金额: $ 12.54万
• 依托单位: CONSERVOCARE, LLC
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-01 至 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8251269
• 关键词: Adverse effects; Anesthetics; Animals; Bilateral; Bladder; Bladder Control; Chemicals; Clinical; Clinical Research; Cytolysis; Data; Defecation; Devices; Dorsal; Effectiveness; Electric Stimulation; Electrodes; Elements; Esthesia; Feasibility Studies; Feedback; Frequencies; Goals; Health; Health Care Costs; Healthcare Systems; Human; Implanted Electrodes; Individual; Investigation; Local Anesthetics; Morbidity - disease rate; Motor; Nerve; Nerve Block; Nervous System Trauma; Neural Conduction; Neurologic; Operative Surgical Procedures; Patients; Phase; Plant Roots; Population; Procedures; Process; Protocols documentation; Proxy; Quality of life; Reflex action; Reporting; Research; Resources; Rhizotomy procedure; Screening procedure; Sensory; Sex Functioning; Spinal cord injury; Spinal nerve root structure; System; Technology; TimeLine; Translating; Translations; Urethral sphincter; clinical efficacy; cost; design; implantable device; implantation; improved; innovation; meetings; nervous system disorder; neural prosthesis; operation; patient population; prevent; prototype

DESCRIPTION (provided by applicant): Abnormal urethral sphincter contractions can prevent bladder emptying and cause significant morbidity and reduction in quality of life after neurological disease or injury. Existing treatment options are of limited effectiveness, destructive, or possess systemic side effects, reducing patient acceptance of these therapies. Electrical stimulation of sacral motor nerve roots can restore bladder voiding after SCI; however only when combined with the irreversible surgical transection of the sensory spinal nerve roots (i.e., a dorsal rhizotomy) to eliminate reflex contractions of the urethral sphincter that otherwise prevent voiding. Other effects of the rhizotomy (loss of remaining sensation, reflex sexual function and reflex defecation) limit the clinical acceptance of this procedure. The goal of this project is to develop a neural prosthesis that uses electrical pudendal nerve block to eliminate urethral sphincter activation and allow bladder voiding. High frequency nerve block provides, rapid, complete and reversible local nerve conduction block. We have demonstrated that bilateral pudendal nerve block can prevent urethral sphincter activation and produce bladder voiding equivalent to nerve transection in animals. We have also demonstrated that pudendal nerve block can be achieved with available nerve cuff electrodes approvable for human studies. Demonstration of electrical pudendal block and improved voiding in humans is the next major milestone to translate this approach to humans. Implantation of a pudendal nerve cuff electrode for the feasibility study requires FDA approval of an investigational device exemption (IDE). This Phase I project will identify and prepare the necessary components for an FDA investigational device exemption (IDE) application and conduct a pre-IDE meeting with the FDA. This process and the pre-IDE FDA meeting will define the effort and resources required to obtain FDA approval to conduct the human feasibility trial in the next phase (next application). This Phase I project will also establish a screening procedure using temporary anesthetic pudendal nerve block and identify initial candidates for the implanted device. At the end of this Phase I project, we will be ready to assemble and submit an IDE to conduct the human feasibility study in the next phase. This approach is expected to expand the population of individuals who could benefit from neural prostheses to control the bladder, and thereby improve their health and quality of life while reducing costs to the healthcare system. PUBLIC HEALTH RELEVANCE: Abnormal urethral sphincter contractions can prevent bladder emptying. This project begins the translation of a neural prosthesis to restore bladder voiding using electrical pudendal nerve block of the urethral sphincter.

描述（由申请人提供）：异常的尿道括约肌收缩会阻止膀胱排空，并在神经系统疾病或损伤后导致显着的发病率和生活质量下降。现有的治疗方案效果有限、具有破坏性或具有全身副作用，从而降低了患者对这些疗法的接受度。电刺激骶运动神经根可恢复 SCI 后膀胱排尿；然而，只有与感觉脊神经根的不可逆手术横断术（即背神经根切断术）相结合，才能消除尿道括约肌的反射性收缩，否则会阻止排尿。神经根切断术的其他影响（剩余感觉丧失、反射性功能和反射性排便）限制了该手术的临床接受度。该项目的目标是开发一种神经假体，使用电阴部神经阻滞来消除尿道括约肌激活并允许膀胱排尿。高频神经阻滞提供快速、完全和可逆的局部神经传导阻滞。我们已经证明，双侧阴部神经阻滞可以防止尿道括约肌激活并产生相当于动物神经横断的膀胱排尿。我们还证明，使用可用于人体研究的神经袖带电极可以实现阴部神经阻滞。在人类中展示电阴部阻滞和改善排尿是将这种方法转化为人类的下一个重要里程碑。用于可行性研究的阴部神经袖带电极植入需要 FDA 批准研究设备豁免 (IDE)。该第一阶段项目将确定并准备 FDA 研究器械豁免 (IDE) 申请所需的组件，并与 FDA 举行 IDE 前会议。该流程和 IDE 前 FDA 会议将确定获得 FDA 批准在下一阶段（下一个申请）进行人体可行性试验所需的努力和资源。该第一阶段项目还将建立使用临时麻醉阴部神经阻滞的筛查程序，并确定植入装置的初始候选者。在第一阶段项目结束时，我们将准备好组装并提交一个 IDE，以在下一阶段进行人类可行性研究。这种方法预计将扩大可以受益于控制膀胱的神经假体的人群，从而改善他们的健康和生活质量，同时降低医疗保健系统的成本。 公众健康相关性：尿道括约肌异常收缩会阻碍膀胱排空。该项目开始使用尿道括约肌的阴部神经电阻滞来翻译神经假体以恢复膀胱排尿。