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

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.

我们的目标医疗状况是逼尿肌活动不足，即膀胱问题 这些人无法有效地排空膀胱。这是临床上普遍存在的 与膀胱过度活动症和尿失禁相比，这一问题受到的关注要少得多。我们 建议使用 Medtronic Interstim 植入式阴部神经神经调节 神经刺激器，用于评估接受刺激的患者的刺激驱动排尿 刺激器作为膀胱问题的治疗方法。我们预计这项研究代表了低水平 的风险。虽然我们正在研究植入物，但 Interstim 设备已获得 FDA 批准用于 正在研究的条件下，我们已经在标签外的位置植入该设备 使用。我们将使用成像和电生理学来绘制 10 名患者的阴部神经图 接受植入物。接下来，我们将创建患者特定的植入物计算模型 和神经，使我们能够模拟招募膀胱兴奋的最佳刺激范例 阴部神经的通路。这些最佳范例将在后续测试中进行评估 我们将与患者进行会谈，寻求推动膀胱排尿反应。最后两场 这项研究的参与者将有逼尿肌活动不足，使我们能够评估我们的 该方法适用于目标患者群体。我们的研究成果将包括证明 成功驱动膀胱收缩和排尿，创建经过验证的患者特异性 阴部神经刺激的计算模型，以及绘制阴部神经解剖图。 图 1 显示了我们的总体研究设计，以及我们预期研究的示例图 我们团队实施的另一种神经调节方法的进展[1]。 SPARC 计划的主要目标是增强解剖学和 自主器官的功能性神经支配，以改善神经调节疗法。 我们相信我们的项目完全符合这一目标，因为我们将使用成像和 电生理学技术在相关临床中绘制支配盆腔器官的关键神经 人口。整个 SPARC 计划的主要成果将是一个用于模拟 用户选择的对末端器官的神经调节治疗。我们的计划是针对特定患者进行 阴部神经神经调节的建模与该计划的结果直接一致，并且 可以直接集成到该模拟器中。