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）：异常尿道括约肌收缩可阻止膀胱排空，并导致神经系统疾病或损伤后的显著发病率和生活质量下降。现有的治疗选择是有限的有效性，破坏性，或具有全身性的副作用，减少患者接受这些疗法。骶运动神经根的电刺激可以恢复SCI后的膀胱排尿;然而，只有当与感觉脊神经根的不可逆手术横断（即，背根切断术）以消除尿道括约肌的反射性收缩，否则该反射性收缩会阻止排尿。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。本计画的目标是开发一种神经假体，利用电性阴部神经阻断来消除尿道括约肌的活动，并允许膀胱排尿。高频神经阻滞可提供快速、完全、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，并产生相当于神经切断动物膀胱排尿。我们还证明，阴部神经阻滞可以实现与现有的神经袖电极批准的人类研究。电阴部阻滞和改善人类排尿的示范是将这种方法应用于人类的下一个重要里程碑。植入阴部神经袖带电极进行可行性研究需要FDA批准试验用器械豁免（IDE）。本I期项目将确定和准备FDA试验用器械豁免（IDE）申请的必要组成部分，并与FDA举行IDE前会议。该过程和IDE前FDA会议将确定获得FDA批准在下一阶段（下一次申请）进行人体可行性试验所需的工作和资源。该I期项目还将使用临时麻醉阴部神经阻滞建立筛选程序，并确定植入器械的初始候选者。在第一阶段项目结束时，我们将准备组装并提交IDE，以便在下一阶段进行人体可行性研究。这种方法有望扩大可以从神经假体中受益的人群，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。 公共卫生相关性：尿道括约肌收缩异常可阻止膀胱排空。这个项目开始翻译的神经假体，以恢复膀胱排尿电阴部神经阻滞尿道括约肌。