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.

神经性疾病或损伤后的神经源性膀胱功能障碍，如脊髓损伤(SCI)可导致 对于膀胱反射亢进，当膀胱体积较小时，膀胱会反射性地反复收缩。膀胱 反射亢进可引发自主神经反射障碍，导致大小便失禁、尿路感染、肾脏损害。 并降低了独立性和生活质量。我们的长期目标是开发并在临床上实施一种 “膀胱起搏器”可恢复脊髓损伤退伍军人的膀胱可控性。 电刺激感觉生殖神经可抑制参与多发性硬化的脊髓神经回路 反射性膀胱痉挛。生殖器神经刺激(GNS)已被多个群体用来抑制反射 急性(1次就诊)尿动力学检查中神经源性膀胱收缩。然而，这一政策的有效性 感觉通路的刺激可以习惯性，也可以随着重复激活而减少。我们最近做了一次。 证明了表面GNS抑制反射性膀胱收缩和减少个人尿失禁 在一个月的家庭使用期间，使用有限的刺激系统进行脊髓损伤。来自以下方面的资深反馈 研究发现了一些对日常生活和生活活动产生负面影响的刺激系统问题 阻止一些受试者参与这项研究。所需的改进包括消除有线 连接、更小的设备、扩展的刺激功能和改进的用户界面。 这项建议的目的是：1)确定感觉神经刺激的有效性 长期(≥1年)减少脊髓损伤退伍军人的大小便失禁并提高生活质量2)产生 有效的带回家的GNS系统，可以被更多的人使用，并用于多站点研究。这个 这项研究的成功将被用于对肾小球肾炎进行多点研究，并导致临床实施。