Triggered sacral neuromodulation to treat neurogenic detrusor overactivity based on algorithmic classification of bladder filling status from wireless pressure data.

根据无线压力数据对膀胱充盈状态的算法分类，触发骶神经调节来治疗神经源性逼尿肌过度活动。

• 批准号: 10317462
• 负责人: Steve Majerus
• 金额: --
• 依托单位: LOUIS STOKES CLEVELAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-11-01 至 2024-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10317462
• 关键词: Activities of Daily Living; Affect; Algorithms; Autonomic Dysreflexia; Awareness; Behavior; Bladder; Botox; Catheters; Clinical; Computer software; Custom; Data; Detection; Diabetic Neuropathies; Disadvantaged; Disease; Effectiveness; Elderly; Evaluation; Event; Extravasation; Feasibility Studies; Feedback; Female; Frequencies; Future; Goals; Home; Hour; Human; Incontinence; Independent Living; Individual; Injections; Intestines; Kidney Failure; Label; Lead; Major Depressive Disorder; Measures; Meta-Analysis; Methods; Modeling; Multiple Sclerosis; Nerve; Nerve Degeneration; Outcome Measure; Parkinson Disease; Peripheral; Phase; Post-Traumatic Stress Disorders; Questionnaires; Radio; Rattus; Readiness; Reflux; Refractory; Reporting; Research; Research Project Grants; Risk; Sepsis; Sexual Dysfunction; Sheep; Signal Transduction; Social isolation; Spinal cord injury; Stroke; Symptoms; System; Technology; Testing; Time; Translational Research; Translations; Treatment Effectiveness; Urinary Incontinence; Urinary Retention; Urinary tract infection; Urine; Urodynamics; Veterans; Woman; Work; base; classification algorithm; comorbidity; decubitus ulcer; diaries; experience; fall risk; first-in-human; functional decline; implantation; improved; improved outcome; male; men; military service; neuroregulation; pressure; response; sensor; tool; translational goal; transmission process; treatment response; urinary; wireless; wireless communication; wireless sensor

Neurogenic detrusor overactivity (NDO) resulting from spinal cord injury or disorder (SCI/D) affects 80% of individuals with SCI/D. It is also associated with peripheral neurodegenerative conditions such as Parkinson’s disease, multiple sclerosis, diabetic neuropathy, or stroke. NDO causes urinary incontinence that profoundly impacts dignified, independent living, associates with numerous comorbidities and fall risk, and is a leading factor in functional decline among the elderly. Urinary incontinence contributes to social isolation and clinical depression and associates with military service and post-traumatic stress disorder in Veterans. Restoring urine storage is consistently cited as a high priority by individuals with NDO. Continuous SNM is an off-label treatment, which is effective for some individuals with NDO. Triggered sacral neuromodulation—in which SNM is applied only during the portion of the bladder fill cycle where NDO occurs—could show unique benefit in treatment in some individuals. While triggered SNM increased bladder capacity in sheep and rats, feasibility has not yet been demonstrated in humans with NDO. The primary goal of this research is to demonstrate the feasibility of increasing bladder capacity and reducing bladder filling pressures using triggered SNM in Veterans with NDO. This will expand on unique technologies developed by our team: the UroMonitor, the Context-Aware Threshold (CAT) algorithm, and the Application Specific Control Unit (ASCU). The UroMonitor is a small, transurethrally-inserted sensor that wirelessly transmits bladder pressure data. CAT is a wavelet-based algorithm that detects detrusor contractions from pressure data in real time. The ASCU is a modular neurostimulation platform supporting wireless communication and custom control software. We will modify and integrate these technologies to demonstrate the feasibility of automatically triggering SNM in Veterans. A secondary goal is to use the UroMonitor to determine bladder capacity, detrusor contraction rate, and filling pressures during a percutaneous SNM evaluation to identify individuals who respond to SNM therapy before a permanent implantation. Both translational goals will be accomplished through two Specific Aims (SA): SA1 will determine the change in bladder response to conditionally-triggered SNM during natural filling cycles after a two-week sacral neuromodulation evaluation phase in Veterans with NDO. In SA1a we will integrate a short-range radio and low-power algorithm processor into the ASCU to trigger percutaneous SNM under algorithm control. In SA1b we will develop and bench-validate a classification algorithm capable of triggering SNM based on adaptive detection of detrusor contractions. In SA1c we will apply triggered SNM using data transmitted from the UroMonitor to the ASCU. Triggered SNM will be applied for eight hours at three timepoints in the two-week percutaneous evaluation phase in eight Veterans. Voided urine volume, time between voids, and detrusor contraction frequency will be compared to determine change in conditional SNM response at the two timepoints and compared to baseline. Outcome measures will be measured from validated questionnaires, catheter-referenced bladder pressures, and collected voided urine. SA2 will determine change in bladder capacity, filling pressure, and detrusor contraction frequency during natural filling cycles throughout a two-week continuous sacral neuromodulation evaluation. In SA2a we will integrate adaptive antennas into the UroMonitor and develop an insertion tool for men and women. SA2b will demonstrate the feasibility of using the UroMonitor to characterize NDO symptoms (bladder capacity, filling pressure, and detrusor contraction rate) over several bladder filling/emptying cycles. Eight Veterans will receive standard, continuous percutaneous SNM for two weeks. NDO symptoms will be measured using the UroMonitor before SNM and after one and two weeks of continuous SNM. Accuracy of symptom quantification will be compared to standard catheter-based testing and validated urinary behavior questionnaires.

由脊髓损伤或疾病（SCI/D）产生的神经源性逆转过度（NDO）影响80％ 患有科幻/d的人。它也与外围神经退行性疾病（如帕金森氏症）有关 疾病，多发性硬化症，糖尿病神经病或中风。 NDO导致尿失禁 影响的影响，独立的生活，具有多种合并症和跌倒风险，是领先的 老年人功能下降的因素。尿失禁有助于社会隔离和临床 抑郁症和与退伍军人的兵役和创伤后应激障碍有关。 NDO患者始终将尿液储存量恢复为高度重视。连续SNM是 标签外治疗，对某些NDO有效。触发s骨神经调节 仅在NDO发生的膀胱填充周期的一部分中应用哪个SNM - 可以显示独特 在某些人的治疗中受益。当触发SNM增加绵羊和老鼠的膀胱容量时， NDO的人类尚未证明可行性。 这项研究的主要目的是证明增加膀胱能力和 使用NDO的退伍军人触发的SNM减少膀胱填充压力。这将扩展独特 我们的团队开发的技术：uromonitor，上下文感知阈值（CAT）算法和 应用特定控制单元（ASCU）。 uromonitor是一种小的，横断的插入传感器，该传感器是 无线传输膀胱压力数据。 CAT是一种基于小波的算法，可检测到逼尿肌 实时压力数据的收缩。 ASCU是一个支持的模块化神经刺激平台 无线通信和自定义控制软件。我们将修改并将这些技术整合到 演示自动在退伍军人中触发SNM的可行性。第二个目标是使用 尿液核定器以确定膀胱容量，迫切收缩率和填充压力 经皮SNM评估，以识别对SNM治疗反应的人 这两个翻译目标将通过两个特定目标（SA）实现： SA1将确定自然填充期间对有条件触发的SNM的膀胱反应的变化 NDO退伍军人进行为期两周的s骨神经调节评估阶段后的循环。在SA1A中，我们将 将短距离无线电和低功率算法处理器集成到ASCU中，以触发经皮SNM 在算法控制下。在SA1B中，我们将开发和替补验证一种能够分类算法 基于对逼rusor收缩的自适应检测触发SNM。在SA1C中，我们将应用触发的SNM 使用从乌象器传输到ASCU的数据。触发的SNM将在三个小时内使用八个小时 在八名退伍军人的两周经皮评估阶段中的时间点。无效的尿量，时间 在空隙和逼尿肌收缩频率之间将进行比较，以确定条件SNM的变化 在两个时间点上的响应，并将其与基线进行比较。结果指标将通过经过验证的 问卷，导管引用的膀胱压力，并收集了尿液。 SA2将确定膀胱容量的变化，填充压力和迫切收缩频率 在为期两周的连续s骨神经调节评估中，自然填充周期。在SA2A中，我们将 将自适应天线整合到泌尿诺剂中，并为男性和女性开发插入工具。 SA2B会 证明使用uromonitor表征NDO符号（膀胱容量，填充）的可行性 在几个膀胱填充/排空周期上的压力和迫切收缩率）。八名退伍军人将 接收标准的，连续的经皮SNM两周。 NDO症状将使用 在SNM之前和一周和两周的连续SNM之后。症状定量的准确性 将与基于标准导管的测试和验证尿液行为问卷进行比较。