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（如脊髓损伤 (SCI)）后的神经源性膀胱功能障碍可导致 膀胱反射亢进，即膀胱在小膀胱容量下反复收缩。 反射亢进可引发自主神经反射异常，导致尿失禁、尿路感染、肾损伤 我们的长期目标是开发并临床实施一种治疗方法。 “膀胱起搏器”能够帮助患有 SCI 的退伍军人恢复膀胱失禁。 感觉生殖神经的电刺激会抑制参与过度兴奋的脊髓神经回路 多个团体已使用反射性膀胱痉挛（GNS）来抑制反射性膀胱痉挛。 急性尿动力学测试期间神经源性膀胱收缩（1 次就诊）然而，其有效性。 我们最近发现，感觉通路的刺激可以随着重复激活而习惯或减少。 表面 GNS 抑制反射性膀胱收缩并减少个体失禁 使用来自这些的退伍军人反馈的有限刺激系统在一个月的家庭使用中进行 SCI。 研究发现了许多刺激系统问题，这些问题对日常生活和活动产生负面影响 阻止了一些受试者参与研究。 需要改进的地方包括取消有线连接。 连接、更小的设备、扩展的刺激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 年）减少 SCI 退伍军人的失禁并提高生活质量，并且 2) 产生 有效的带回家 GNS 系统，可供更多人使用并用于多地点研究。 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。