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.

脊髓损伤或疾病 (SCI/D) 导致的神经源性逼尿肌过度活动 (NDO) 影响 80% 患有 SCI/D 的个体也与帕金森氏症等周围神经退行性疾病有关。 疾病、多发性硬化症、糖尿病性神经病变或中风会严重导致尿失禁。 影响有尊严、独立的生活，与多种合并症和跌倒风险相关，是一个主要的 老年人功能衰退的因素导致社会隔离和临床。 抑郁症与退伍军人服兵役和创伤后应激障碍有关。 连续性 SNM 患者始终将恢复尿液储存视为重中之重。 一种超说明书治疗，对某些 NDO 患者有效。 仅在发生 NDO 的膀胱充盈周期部分应用 SNM — 可以显示出独特的 虽然触发 SNM 可以增加绵羊和大鼠的膀胱容量， 尚未在患有 NDO 的人类中证明其可行性。 这项研究的主要目标是证明增加膀胱容量和 使用 NDO 触发 SNM 来降低退伍军人的膀胱充盈压力 这将扩展独特的功能。 我们团队开发的技术：UroMonitor、上下文感知阈值 (CAT) 算法和 专用控制单元 (ASCU) 是一种小型、经尿道插入的传感器。 无线传输膀胱压力数据 CAT 是一种基于小波的算法，用于检测逼尿肌。 ASCU 是一个模块化神经刺激平台，支持实时压力数据的收缩。 我们将修改和集成这些技术来实现无线通信和定制控制软件。 证明退伍军人自动触发 SNM 的可行性。第二个目标是使用 UroMonitor 用于确定膀胱容量、逼尿肌收缩率和充盈压力 经皮 SNM 评估，以确定在永久治疗前对 SNM 治疗有反应的个体 两个转化目标将通过两个具体目标（SA）来实现： SA1 将确定自然充盈期间膀胱对条件触发 SNM 的反应变化 在 SA1a 中，我们将在患有 NDO 的退伍军人中进行为期两周的骶神经调节评估阶段后的周期。 将短程无线电和低功耗算法处理器集成到 ASCU 中以触发经皮 SNM 在算法控制下，我们将开发并验证能够执行以下操作的分类算法： 基于逼尿肌收缩的自适应检测触发 SNM 在 SA1c 中，我们将应用触发 SNM。 使用从 UroMonitor 传输到 ASCU 的数据将在三点应用八小时。 八名退伍军人的两周经皮评估阶段的时间点排尿量、时间。 将比较空隙之间的情况和逼尿肌收缩频率，以确定条件 SNM 的变化 将根据经过验证的结果来衡量两个时间点的反应并与基线进行比较。 问卷调查、导管参考膀胱压力并收集排尿。 SA2 将确定膀胱容量、充盈压和逼尿肌频率收缩期间的变化。 在 SA2a 中，我们将进行为期两周的连续骶神经调节评估的自然充盈周期。 将自适应天线集成到 UroMonitor 中并开发适用于男性和女性的插入工具 SA2b。 证明使用 UroMonitor 表征 NDO 症状（膀胱容量、充盈度）的可行性 八名退伍军人将在几个膀胱充盈/排空周期中进行测量。 接受标准、连续经皮 SNM 两周，将使用 NDO 症状进行测量。 SNM 之前以及连续 SNM 一周和两周后的 UroMonitor 症状量化的准确性。 将与标准的基于导管的测试和经过验证的排尿行为问卷进行比较。