Pudendal nerve mapping towards improved neuromodulation for urinary retention

阴部神经映射以改善尿潴留的神经调节

• 批准号: 9807652
• 负责人: Timothy M. Bruns
• 金额: $ 66.82万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9807652
• 关键词: Anatomy; Attention; Bladder; Clinical; Computer Simulation; Devices; Electrophysiology (science); FDA approved; Image; Implant; Incontinence; Individual; Knowledge; Location; Maps; Medical; Modeling; Nerve; Organ; Outcome; Outcome Study; Overactive Bladder; Participant; Pathway interactions; Patients; Pelvis; Population; Research Design; Risk; Techniques; Testing; Urinary Retention; Work; clinically relevant; follow-up; implantable device; improved; nerve supply; neuroregulation; off-label use; programs; recruit; relating to nervous system; response; Anatomy; Attention; Bladder; Clinical; Computer Simulation; Devices; Electrophysiology (science); FDA approved; Image; Implant; Incontinence; Individual; Knowledge; Location; Maps; Medical; Modeling; Nerve; Organ; Outcome; Outcome Study; Overactive Bladder; Participant; Pathway interactions; Patients; Pelvis; Population; Research Design; Risk; Techniques; Testing; Urinary Retention; Work; clinically relevant; follow-up; implantable device; improved; nerve supply; neuroregulation; off-label use; programs; recruit; relating to nervous system; response

Our targeted medical condition is detrusor underactivity, a bladder problem in which individuals are unable to effectively empty their bladder. This is a widespread clinical problem that receives far less attention than overactive bladder and incontinence conditions. We propose to use neuromodulation of the pudendal nerve, with the Medtronic Interstim implantable neurostimulator, to evaluate stimulation-driven voiding in patients that are receiving the stimulator as a treatment for bladder problems. We expect that this study represents a low level of risk. Although we are studying an implant, the Interstim device is approved by the FDA for the conditions under study and we are already implanting the device at this location, in an off-label use. We will use imaging and electrophysiology to map the pudendal nerve in ten patients receiving the implant. Next, we will create patient-specific computational models of the implant and nerve, allowing us to simulate optimal stimulation paradigms for recruiting bladder excitation pathways in the pudendal nerve. These optimal paradigms will be evaluated in a follow-up test session with patients in which we will seek to drive bladder voiding responses. The final two participants in this study will have detrusor underactivity, allowing us to evaluate whether our approach works in the target patient group. Our study outcomes will include demonstrating successfully-driven bladder contractions and voiding, creating validated patient-specific computational models of pudendal nerve stimulation, and mapping pudendal nerve anatomy. Figure 1 shows our overall study design, with example figures of our anticipated study progression as implemented for another neuromodulation approach by our team [1]. A primary objective of the SPARC program is to enhance knowledge of anatomical and functional neural innervation of autonomic organs towards improved neuromodulation therapies. We believe our project aligns perfectly with this objective, as we will use imaging and electrophysiology techniques to map a key nerve innervating pelvic organs in a relevant clinical population. A principal outcome of the entire SPARC program will be a model for simulating a user-selected neuromodulation therapy on an end organ. Our plan to perform patient-specific modeling of pudendal nerve neuromodulation directly aligns with this program outcome, and may integrate directly within that simulator.

我们针对性的医疗状况是越来越多的越来越小的，这是一个膀胱问题 哪些人无法有效清空膀胱。这是一个广泛的临床 与过度活跃的膀胱和尿失禁条件相比，受到关注的问题要少得多。我们 提议使用Medtronic Intermable植入式神经的神经调节 神经刺激剂，以评估接受刺激驱动的失散剂 刺激器作为膀胱问题的治疗。我们希望这项研究代表低水平 风险。尽管我们正在研究植入物，但Interstim设备已由FDA批准 正在研究的条件，我们已经在该位置将设备植入了标签外 使用。我们将使用成像和电生理学来绘制十名患者的底端神经 接收植入物。接下来，我们将创建植入物的特定于患者的计算模型 和神经，使我们能够模拟最佳刺激范例，以募集膀胱激发 底座神经中的途径。这些最佳范例将在后续测试中评估 与我们寻求驱动膀胱无效反应的患者会议。最后两个 这项研究的参与者将使镇定剂不足，从而使我们能够评估我们的 目标患者组有效。我们的研究成果将包括证明 成功驱动的膀胱收缩和排尿，创造了经过验证的患者 刺激性神经刺激的计算模型和绘制底端神经解剖结构。 图1显示了我们的整体研究设计，以及我们预期研究的示例图 我们的团队为另一种神经调节方法实施的进展[1]。 SPARC计划的主要目的是增强解剖学和 自主器官对改善神经调节疗法的功能神经支配。 我们相信我们的项目与这个目标完全一致，因为我们将使用成像和 在相关临床中绘制关键神经支配骨盆器官的电生理技术 人口。整个SPARC计划的主要结果将是模拟A 用户选择的神经调节疗法在最终器官上。我们执行特定患者的计划 阴道神经调节的建模直接与该程序结果保持一致，并 可以直接集成该模拟器。