Pudendal nerve mapping towards improved neuromodulation for urinary retention

我们的目标医疗条件是逼尿肌活动不足，这是 这些人无法有效地排空他们的膀胱。这是一种广泛的临床应用 与膀胱过度活动和大小便失禁相比，这个问题受到的关注要少得多。我们 建议使用神经调节阴部神经，并植入Medtronic Interstim 神经刺激器，以评估接受刺激治疗的患者的刺激驱动排尿 刺激器是治疗膀胱问题的一种方法。我们预计这项研究代表了一个较低的水平 风险的恐惧。虽然我们正在研究一种植入物，但Interstim设备已被FDA批准用于 情况正在研究中，我们已经在这个位置植入了这个装置，在标签外 使用。我们将使用成像和电生理学来标测10名患者的阴部神经。 接受植入手术。接下来，我们将创建针对患者的植入物计算模型 和神经，使我们能够模拟最优的刺激范例来招募膀胱兴奋 阴部神经的通路。这些最佳范例将在后续测试中进行评估 与患者的会议中，我们将寻求推动膀胱排尿反应。最后两名 这项研究的参与者将会有逼尿肌活动不足，这使我们能够评估我们的 方法适用于目标患者组。我们的研究成果将包括证明 成功驱动膀胱收缩和排尿，创建有效的特定于患者的 阴部神经刺激的计算模型和阴部神经解剖图。 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 我们团队为另一种神经调节方法实施的进展[1]。 SPARC计划的一个主要目标是增强解剖学和 自主神经器官的功能性神经支配，走向改进的神经调节疗法。 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 电生理技术在相关临床中对支配盆腔器官的关键神经的标测 人口。整个SPARC计划的主要成果将是一个模拟 在末端器官上进行用户选择的神经调节疗法。我们的计划是针对特定患者执行 阴部神经调节的模型直接与这个项目的结果一致，并且 可以直接集成在该模拟器中。

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.