Transformation of Dormant Spinal Networks to Mitigate Symptoms of Neurogenic Bladder

总结 脊髓损伤总是导致严重的下尿路功能障碍;患者出现泌尿系统疾病。 尿失禁、复发性尿路感染、膀胱排空不全和膀胱压力高。 依靠导管排空膀胱几乎是普遍的。下尿路的成熟疗法 由于脊髓损伤引起的功能障碍的重点是预防和管理并发症，而不是恢复 功能凭借我们多年来在瘫痪后运动功能康复方面的经验，我们有信心 我们也可以改变脊髓损伤患者的膀胱护理模式。经皮 脊髓神经电调节（TESCoN）提供了一种与经典疗法截然不同的方法 对于神经性膀胱：通过向脊髓递送低强度亚运动阈值电脉冲， TESCoN激活脊髓损伤导致的腰椎神经网络功能障碍， 下尿路和负责排尿控制的高级神经中枢之间的通信。 我们的初步研究结果表明TESCoN介导的神经调节可改善膀胱 容量，减少尿失禁，并显着恢复膀胱感觉，即使在个人， 脊髓损伤在临床上被认为是完全性的。 在这个第二阶段的应用中，我们建议建立一个商业版本的TESCoN原型， 设计控制并在临床确认研究中使用器械。我们提出了一个多中心随机对照 试验证明TESCoN对瘫痪的下尿路的有益作用。通过招募60名 脊髓损伤的个体，并比较假刺激和真刺激对他们下尿路的影响。 道，我们的目的是表明，TESCoN在管理和恢复泌尿功能的重要作用， 临床环境（主要结局）。我们公司的学术根基和我们组建的团队 （工程师，企业家和临床医生）确保我们的研究设计，实施和分析将是既 有影响力和严谨。本研究的成功完成将为FDA 510（k）提交提供证据。 最后，如果TESCoN在像脊髓损伤这样具有破坏性的神经损伤的情况下是成功的， 我们有信心，我们将能够把这项技术带给更多的病人， 由于神经和非神经疾病引起的下尿路功能障碍，如中风， 多发性硬化症、帕金森病和特发性膀胱过度活动症。

Summary Spinal cord injury invariably leads to severe dysfunction of the lower urinary tract; patients develop urinary incontinence, recurrent urinary tract infections, incomplete bladder emptying and high bladder pressures. Reliance on catheters to empty the bladder is virtually universal. Established therapies for lower urinary tract dysfunction due to spinal cord injury focus on preventing and managing complications rather than on restoring function. Relying on our years of experience in rehabilitation of motor function after paralysis, we are confident that we can change the paradigm of bladder care in individuals with spinal cord injuries as well. Transcutaneous Electrical Spinal Cord Neuromodulation (TESCoN) offers a diametrically different approach to classic therapies for neurogenic bladder: by delivering low-intensity sub-motor threshold electrical pulses to the spinal cord, TESCoN activates lumbar neural networks rendered dysfunctional by the spinal cord injury and restores some communication between the lower urinary tract and higher neural centers responsible for micturition control. Results from our preliminary studies indicate that TESCoN-mediated neuromodulation improves bladder capacity, diminishes urinary incontinence and, remarkably, restores bladder sensation even in individuals, whose spinal cord injury is considered clinically complete. In this Phase II application, we propose to build a commercial version of the TESCoN prototype under design controls and use the device in a clinical validation study. We propose a multicenter randomized control trial to demonstrate the beneficial effects of TESCoN on the paralyzed lower urinary tract. By recruiting sixty individuals with spinal cord injury and comparing the effects of sham and true stimulation on their lower urinary tract, we aim to show that TESCoN has a significant role in managing and rehabilitating urinary function in the clinical setting (primary outcome). The academic roots of our company and the team we have assembled (engineers, entrepreneurs and clinicians) ensure that our study design, implementation and analysis will be both impactful and rigorous. Successful completion of this study will provide evidence for a FDA 510(k) submission. Finally, if TESCoN is successful in the case of a neurological impairment as devastating as a spinal cord injury, we are confident that we will be able to bring this technology to a much larger population of patients suffering from lower urinary tract dysfunction due to both neurological and non-neurological conditions, such as stroke, multiple sclerosis, Parkinson’s disease and idiopathic overactive bladder.