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）导致神经源性膀胱功能障碍，并且通常包括困难 由于逼尿肌括约肌协同失调（DSD）而排空膀胱。 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 可以使用骶前根刺激（SARS）来排空神经源性膀胱。 植入骶神经的电极可产生膀胱收缩，但这种排空可能会发生。 受尿道括约肌反射性收缩阻碍。骶感觉根通常被横断。 （神经根切断术）以减少这些反射性收缩，但这种神经根切断术也会损害理想的反射（例如性反射） 功能）和骶骨感觉（如果存在）动物实验表明，骶根刺激在。 600 Hz 可以抑制尿道括约肌活动，这种方法有潜力用来代替。 根切断术以提高膀胱排空效率。 目的：本研究的目的是测试 600 Hz 骶根的可行性和潜在有效性 刺激以限制神经源性膀胱功能障碍患者的尿道括约肌活动。 研究表明，与 600 Hz 频率相比，骶根刺激会导致尿道括约肌压力降低 对 SARS 通常使用的较低频率的刺激作出反应的压力。 研究设计：在本可行性研究中，我们将招募 8 名受试者，男性或女性，患有 SCI 且患有 已经使用植入的骶根前部刺激来管理他们的膀胱，参与者将充当他们自己的膀胱。 尿道括约肌抑制的刺激波形将在临床实验室中进行单次测试。 我们不需要进行新的手术或植入程序。主要结果指标是。 尿道括约肌压力，其他结果测量包括膀胱压力、直肠压力和 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排空的方法。 通过消除骶骨后神经根切断术的需要来排空。