Long Term Genital Nerve Stimulation to Improve Urinary Continence

长期生殖神经刺激改善尿失禁

• 批准号: 10402756
• 负责人: Steven W. Brose
• 金额: --
• 依托单位: LOUIS STOKES CLEVELAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-06-01 至 2022-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10402756
• 关键词: Activities of Daily Living; Acute; Address; Autonomic Dysreflexia; Bladder; Bladder Control; Bladder Dysfunction; Blood Pressure; Case Study; Chronic; Clinical; Clinical effectiveness; Computer software; Contracts; Dangerousness; Data; Devices; Effectiveness; Electric Stimulation; Enrollment; Event; FPS-FES Oncogene; Feedback; Future; Genital; Genitalia; Goals; Hand functions; Home; Hyperreflexia; Impairment; Incontinence; Individual; Lead; Measures; Monitor; Nerve; Nervous System Trauma; Neurogenic Bladder; Neurologic; Neurologic Dysfunctions; Operative Surgical Procedures; Overactive Bladder; Pacemakers; Pathway interactions; Pattern; Pharmacological Treatment; Quality of life; Reflex action; Resources; Sensory; Site; Spasm; Spinal; Spinal cord injury; Surface; System; Technology; Testing; Time; Urinary Incontinence; Urinary tract infection; Urodynamics; Use Effectiveness; Validation; Veterans; Visit; Wireless Technology; afferent nerve; clinical implementation; design; effectiveness evaluation; implantable device; improved; nervous system disorder; neural circuit; neurological pathology; prevent; recruit; renal damage; safety testing; side effect; success

Neurogenic bladder dysfunction after neurologic disease or injury such as spinal cord injury (SCI) can lead to bladder hyper-reflexia where the bladder reflexively contracts repeatedly at small bladder volumes. Bladder hyper-reflexia can trigger autonomic dysreflexia, result in incontinence, urinary tract infections, renal damage and decreased independence and quality of life. Our long-term goal is to develop and clinically implement a “bladder pacemaker” able to restore bladder continence for veterans with SCI. Electrical stimulation of the sensory genital nerves inhibits the spinal neural circuits involved in hyper- reflexive bladder spasms. Genital nerve stimulation (GNS) has been used by multiple groups to inhibit reflexive neurogenic bladder contractions during acute (1 visit) urodynamic testing. However, the effectiveness of stimulation of sensory pathways can habituate or decrease with repetitive activation. We have recently  demonstrated that surface GNS inhibits reflexive bladder contractions and reduces incontinence in individuals with SCI during one month of home use using a limited stimulation system. Veteran feedback from these studies identified a number of stimulation system issues that negatively impacted activities of daily living and prevented some subjects from participating in the study. Required improvements include elimination of wired connections, a smaller device, expanded stimulation capabilities, and an improved user interface. The purposes of this proposal are to 1) determine the effectiveness of sensory nerve stimulation to chronically (≥1 year) reduce incontinence and improve quality of life for veterans with SCI and 2) produce an effective take home GNS system that can be used by more individuals and used for multi-site studies. The success of this study will be used to conduct a multi-site study of GNS and lead to clinical implementation.

神经系统疾病或损伤（例如脊髓损伤（SCI））的神经源性膀胱功能障碍可以领导 在小膀胱质量在小膀胱体积上反复收缩的膀胱反射症。膀胱 超反射可以触发自主性逆转录病毒，导致尿失禁，尿路感染，肾脏损害 并发展了独立性和生活质量。我们的长期目标是开发和临床实施 “膀胱起搏器”可以恢复具有SCI的退伍军人的膀胱延续。 感觉生殖器神经的电模拟抑制了参与高度的脊柱神经回路 反身膀胱痉挛。生殖器神经刺激（GNS）已被多组用于抑制反射性 急性（1次访问）尿动力测试期间的神经源性膀胱收缩。但是，有效性 刺激感觉途径可以随着重复激活而习惯或减少。我们最近有 证明表面GN抑制反射性膀胱收缩并降低个体的尿失禁 使用有限的刺激系统在家庭使用的一个月内使用SCI。这些来自这些的退伍军人反馈 研究确定了许多模拟系统问题，这些问题对日常生活的活动产生了负面影响 阻止了一些受试者参加研究。所需的改进包括消除有线 连接，较小的设备，扩展的仿真功能以及改进的用户界面。 该提案的目的是1）确定感觉神经刺激的有效性 长期（≥1岁）降低了尿失禁并改善了SCI和2）的生活质量 有效的带回家GNS系统，可以被更多个体使用并用于多站点研究。这 这项研究的成功将用于进行GNS多站点研究，并导致临床实施。