Department of Urology, Ochsner Medical Center, New Orleans, LA, USA.
Medtronic Pelvic Health, Minneapolis, MN, USA.
Neuromodulation. 2024 Feb;27(2):392-398. doi: 10.1016/j.neurom.2023.07.002. Epub 2023 Aug 16.
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.
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.
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.
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.
骶神经调节（SNM）疗法的标准护理依赖于视觉-运动反应和患者报告的感觉反应，以确定优化的引线放置和编程。刺激反应的自动检测可以为优化 SNM 提供一个简单、一致的指标。本研究旨在测量和描述使用商业的有齿 SNM 引线刺激骶神经时产生的骶神经诱发电位（SER）。
在对 SNM 进行分期（有齿引线）评估期间，将带有刺激和感应硬件的定制外部研究系统连接到植入引线的经皮延伸部分。该系统在 21 名患有膀胱过度活动症（OAB）和非梗阻性尿潴留（NOUR）的患者的术中及术后会议期间，在一系列预设刺激设置（双极刺激和双极感应的电极配置组合）下收集 SER 记录。在同一会议期间收集了运动和感觉阈值。
在所有 21 名受试者中均检测到 SER。SER 形态（峰数、幅度和时间）在受试者内和受试者间的电极配置中有所不同。在测试的受试者和电极配置中，记录在 75%至 80%的受试者中包含在运动阈值和/或感觉阈值处的 SER。
本研究证实，植入的 SNM 引线可用于直接记录 OAB 和 NOUR 患者刺激引起的 SER。在典型的 SNM 刺激设置和程序时间点，SER 很容易被检测到。将这些 SER 用作 SNM 反应的可能客观测量指标，有可能实现患者特定的 SNM 治疗的自动化，从而提供一致的引线放置、编程和/或闭环治疗。
