Abstract：
OBJECTIVE: Sacral neuromodulation (SNM) therapy standard of care relies on visual-motor responses and patient-reported sensory responses in deciding optimized lead placement and programming. Automatic detection of stimulation responses could offer a simple, consistent indicator for optimizing SNM. The purpose of this study was to measure and characterize sacral evoked responses (SERs) resulting from sacral nerve stimulation using a commercial, tined SNM lead.
METHODS: A custom external research system with stimulation and sensing hardware was connected to the percutaneous extension of an implanted lead during a staged (tined lead) evaluation for SNM. The system collected SER recordings across a range of prespecified stimulation settings (electrode configuration combinations for bipolar stimulation and bipolar sensing) during intraoperative and postoperative sessions in 21 subjects with overactive bladder (OAB) and nonobstructive urinary retention (NOUR). Motor and sensory thresholds were collected during the same sessions.
RESULTS: SERs were detected in all 21 subjects. SER morphology (number of peaks, magnitude, and timing) varied across electrode configurations within and across subjects. Among subjects and electrode configurations tested, recordings contained SERs at motor threshold and/or sensory threshold in 75% to 80% of subjects.
CONCLUSIONS: This study confirmed that implanted SNM leads can be used to directly record SERs elicited by stimulation in subjects with OAB and NOUR. SERs were readily detectable at typical SNM stimulation settings and procedural time points. Using these SERs as possible objective measures of SNM response has the capability to automate patient-specific SNM therapy, potentially providing consistent lead placement, programming, and/or closed-loop therapy.
METHODS: A custom external research system with stimulation and sensing hardware was connected to the percutaneous extension of an implanted lead during a staged (tined lead) evaluation for SNM. The system collected SER recordings across a range of prespecified stimulation settings (electrode configuration combinations for bipolar stimulation and bipolar sensing) during intraoperative and postoperative sessions in 21 subjects with overactive bladder (OAB) and nonobstructive urinary retention (NOUR). Motor and sensory thresholds were collected during the same sessions.
RESULTS: SERs were detected in all 21 subjects. SER morphology (number of peaks, magnitude, and timing) varied across electrode configurations within and across subjects. Among subjects and electrode configurations tested, recordings contained SERs at motor threshold and/or sensory threshold in 75% to 80% of subjects.
CONCLUSIONS: This study confirmed that implanted SNM leads can be used to directly record SERs elicited by stimulation in subjects with OAB and NOUR. SERs were readily detectable at typical SNM stimulation settings and procedural time points. Using these SERs as possible objective measures of SNM response has the capability to automate patient-specific SNM therapy, potentially providing consistent lead placement, programming, and/or closed-loop therapy.
摘要：
目的：骶神经调节（SNM）治疗标准依赖于视觉运动反应和患者报告的感觉反应来决定优化的导线放置和编程。自动检测刺激反应可以提供一个简单的，优化SNM的一致指标。这项研究的目的是测量和表征由骶神经刺激引起的骶诱发反应（SER）使用商业，镀锡SNM铅。
方法：在对SNM进行分阶段（染色导线）评估期间，将带有刺激和传感硬件的定制外部研究系统连接到植入导线的经皮延伸。该系统在21例膀胱过度活动症（OAB）和非阻塞性尿潴留（NOUR）患者的术中和术后会话期间，收集了一系列预定刺激设置（双极刺激和双极感应的电极配置组合）的SER记录。在相同的疗程中收集运动和感觉阈值。
结果：在所有21名受试者中均检测到SERs。SER形态(峰数,量级,和定时）在受试者内部和受试者之间的电极配置之间变化。在测试的受试者和电极配置中，记录包含75％至80％的受试者的运动阈值和/或感觉阈值的SER。
结论：这项研究证实，植入的SNM导线可用于直接记录OAB和NOUR受试者的刺激引起的SERs。在典型的SNM刺激设置和程序时间点容易检测到SER。使用这些SERs作为SNM反应的可能的客观测量具有自动化患者特异性SNM治疗的能力。可能提供一致的引线放置，编程，和/或闭环治疗。
方法：在对SNM进行分阶段（染色导线）评估期间，将带有刺激和传感硬件的定制外部研究系统连接到植入导线的经皮延伸。该系统在21例膀胱过度活动症（OAB）和非阻塞性尿潴留（NOUR）患者的术中和术后会话期间，收集了一系列预定刺激设置（双极刺激和双极感应的电极配置组合）的SER记录。在相同的疗程中收集运动和感觉阈值。
结果：在所有21名受试者中均检测到SERs。SER形态(峰数,量级,和定时）在受试者内部和受试者之间的电极配置之间变化。在测试的受试者和电极配置中，记录包含75％至80％的受试者的运动阈值和/或感觉阈值的SER。
结论：这项研究证实，植入的SNM导线可用于直接记录OAB和NOUR受试者的刺激引起的SERs。在典型的SNM刺激设置和程序时间点容易检测到SER。使用这些SERs作为SNM反应的可能的客观测量具有自动化患者特异性SNM治疗的能力。可能提供一致的引线放置，编程，和/或闭环治疗。
