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: 10731729
• 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 2023-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10731729
• 关键词: Activities of Daily Living; Acute; Address; Autonomic Dysreflexia; Bladder; Bladder Control; Bladder Dysfunction; 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; Measures; Monitor; Nerve; Nervous System Trauma; Neurogenic Bladder; Neurologic; Neurologic Dysfunctions; Operative Surgical Procedures; Pacemakers; Pathway interactions; Pattern; Pharmacological Treatment; Quality of life; Resources; Sensory; Site; Spasm; Spinal; Spinal cord injury; Surface; System; Technology; Testing; Time; Urinary Incontinence; Urinary tract infection; Urodynamics; Validation; Vertebral column; Veterans; Visit; afferent nerve; blood pressure elevation; clinical implementation; comparison control; design; effectiveness evaluation; habituation; implantable device; improved; nervous system disorder; neural circuit; neurological pathology; prevent; recruit; renal damage; safety testing; side effect; success; wireless

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（如脊髓损伤（SCI））后的神经源性膀胱功能障碍可导致 到膀胱反射亢进，其中膀胱反射性地以小膀胱体积反复收缩。膀胱 反射亢进可触发自主反射异常，导致失禁、尿路感染、肾损伤 独立性和生活质量下降。我们的长期目标是开发和临床实施一种 “膀胱起搏器”能够恢复膀胱功能的退伍军人与脊髓损伤。 电刺激感觉生殖神经抑制脊髓神经回路参与超- 反射性膀胱痉挛生殖神经刺激（GNS）已被多个团体用于抑制反射性 急性（1次访视）尿动力学检查期间神经源性膀胱收缩。然而， 感觉通路的刺激可以随着重复激活而习惯或减少。我们最近 表明，表面GNS抑制反射性膀胱收缩，并减少个人尿失禁 在一个月的家庭使用期间，使用有限的刺激系统。来自这些的资深反馈 研究确定了一些刺激系统问题，这些问题对日常生活活动产生了负面影响， 阻止了一些受试者参与研究。所需的改进包括消除有线 连接、更小的设备、扩展的刺激能力和改进的用户界面。 本提案的目的是：1）确定感觉神经刺激的有效性， 慢性（≥1年）减少尿失禁并改善SCI退伍军人的生活质量，2）产生 有效的带回家GNS系统，可供更多人使用，并用于多中心研究。的 这项研究的成功将用于进行GNS的多中心研究，并导致临床实施。