High frequency sacral root stimulation to improve bladder and bowel emptying following SCI

高频骶根刺激可改善 SCI 后膀胱和肠道排空

• 批准号: 10662457
• 负责人: DENNIS BOURBEAU
• 金额: --
• 依托单位: LOUIS STOKES CLEVELAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10662457
• 关键词: Acute; Address; American; Animals; Anterior; Ataxia; Autonomic Dysreflexia; Bladder; Bladder Control; Bladder Dysfunction; Catheterization; Catheters; Chronic; Clinical; Clinical Trials; Computer software; Coupled; Data; Devices; Effectiveness; Electric Stimulation; Enrollment; Esthesia; FDA approved; Feasibility Studies; Female; Frequencies; Future; Goals; Healthcare Systems; Human; Iatrogenesis; Impairment; Implant; Implantation procedure; Implanted Electrodes; Individual; Injury; Interruption; Intervention; Intestines; Laboratories; Life; Manufacturer; Measures; Medical; Methods; Motor; Muscle Contraction; Muscle Fatigue; Nerve; Neurogenic Bladder; Neurotransmitters; Operative Surgical Procedures; Outcome Measure; Participant; Pattern; Pharmacologic Substance; Physiologic pulse; Pilot Projects; Population; Recovery; Rectum; Reflex action; Reflux; Relaxation; Research; Research Design; Rhizotomy procedure; Risk; Sacral nerve; Safety; Sensory; Sex Functioning; Sphincter; Spinal cord injury; Spinal nerve structure; Stimulus; System; Techniques; Testing; Urethral sphincter; Urinary Incontinence; Urinary tract infection; Urodynamics; Vertebral column; Veterans; Work; afferent nerve; clinical implementation; cost; experimental study; feasibility testing; hospital readmission; improved; innovation; male; pilot test; preservation; pressure; prevent; primary outcome; recruit; rectal; renal damage; response; side effect; sphincter ani muscle structure

Background: Spinal cord injury (SCI) leads to neurogenic bladder dysfunctions, and often includes difficulty with emptying the bladder due to detrusor-sphincter dyssynergia (DSD). Current bladder management strategies include catheterization, pharmaceuticals, and/or surgery, but these interventions insufficiently meet individuals’ needs. The neurogenic bladder can be emptied using sacral anterior root stimulation (SARS) with electrodes implanted on the sacral nerves to produce bladder contractions. However, this emptying can be impeded by reflex contractions of the urethral sphincter. The sacral sensory roots are typically transected (rhizotomy) to reduce these reflex contractions, but this rhizotomy also impairs desirable reflexes (e.g. sexual function) and sacral sensation if present. Experiments in animals have shown that sacral root stimulation at 600 Hz can inhibit urethral sphincter activity, which has the potential. This approach could be used in lieu of the rhizotomy to improve bladder emptying efficiency. Objective: The objective of this study is to test the feasibility and potential effectiveness of 600 Hz sacral root stimulation to limit urethral sphincter activity in individuals with neurogenic bladder dysfunction. We hypothesize that sacral root stimulation at 600 Hz will result in lower urethral sphincter pressures compared to pressures in response to stimulation at the lower frequencies that are typically used for SARS. Study Design: In this feasibility study, we will enroll 8 participants, male or female, who have SCI and who already use implanted sacral root anterior stimulation to manage their bladder. Participants will act as their own controls. Stimulus waveforms for urethral sphincter inhibition will be tested in the clinical laboratory in a single session. We will not need to conduct new surgeries or implant procedures. The primary outcome measure is urethral sphincter pressure, and additional outcome measures include bladder pressure, rectal pressure, and bladder volume as measured in clinically standard urodynamics examination. Clinical Impact: This approach could help restore bladder function by reducing urethral sphincter activity that impedes bladder emptying for individuals with SCI. We could improve approaches for promoting bladder emptying by eliminating the need for sacral posterior rhizotomy.

背景：脊髓损伤（SCI）可导致神经源性膀胱功能障碍， 由于逼尿肌-括约肌协同失调（DSD）而排空膀胱。当前膀胱管理 策略包括导管插入术，药物和/或手术，但这些干预措施不足以满足 个人的需要。神经源性膀胱可以使用骶前根刺激（SARS）排空， 植入骶神经以产生膀胱收缩的电极。然而，这种排空可以是 被尿道括约肌的反射收缩阻碍。骶骨感觉根通常是横断的 （神经根切断术）以减少这些反射收缩，但是这种神经根切断术也损害期望的反射（例如，性反射）。 功能）和骶骨感觉（如果存在）。动物实验表明，骶神经根刺激， 600 Hz可抑制尿道括约肌活动，具有潜力。这种方法可以用来代替 神经根切断术以改善膀胱排空效率。 目的：探讨600 Hz骶神经根电刺激的可行性和潜在疗效 刺激以限制神经源性膀胱功能障碍个体的尿道括约肌活动。我们 假设600 Hz骶神经根刺激将导致尿道括约肌压力较低， 压力响应于在通常用于SARS的较低频率下的刺激。 研究设计：在这项可行性研究中，我们将招募8名男性或女性SCI患者， 已经使用植入的骶神经根前刺激来管理他们的膀胱。参与者将作为自己的 对照尿道括约肌抑制的刺激波形将在临床实验室中进行测试， 上网时段我们将不需要进行新的手术或植入程序。主要结局指标是 尿道括约肌压力，以及额外的结果测量包括膀胱压力，直肠压力， 在临床标准尿动力学检查中测量的膀胱体积。 临床影响：这种方法可以通过减少尿道括约肌活动来帮助恢复膀胱功能， 阻碍SCI患者的膀胱排空。我们可以改进促进膀胱的方法 通过消除对骶后根切断术的需要来排空。