High frequency sacral root stimulation to improve bladder and bowel emptying following SCI
High frequency sacral root stimulation to improve bladder and bowel emptying following SCI
批准号:
10662457
负责人:
DENNIS BOURBEAU
金额:
$0.0万
依托单位国家:
美国
项目类别:
财政年份:
2022
资助国家:
美国
项目状态:
已结题
起止时间:
2022-07-01 至 2024-06-30
关键词:
AcuteAddressAmericanAnimalsAnteriorAtaxiaAutonomic DysreflexiaBladderBladder ControlBladder DysfunctionCatheterizationCathetersChronicClinicalClinical TrialsComputer softwareCoupledDataDevicesEffectivenessElectric StimulationEnrollmentEsthesiaFDA approvedFeasibility StudiesFemaleFrequenciesFutureGoalsHealthcare SystemsHumanIatrogenesisImpairmentImplantImplantation procedureImplanted ElectrodesIndividualInjuryInterruptionInterventionIntestinesLaboratoriesLifeManufacturerMeasuresMedicalMethodsMotorMuscle ContractionMuscle FatigueNerveNeurogenic BladderNeurotransmittersOperative Surgical ProceduresOutcome MeasureParticipantPatternPharmacologic SubstancePhysiologic pulsePilot ProjectsPopulationRecoveryRectumReflex actionRefluxRelaxationResearchResearch DesignRhizotomy procedureRiskSacral nerveSafetySensorySex FunctioningSphincterSpinal cord injurySpinal nerve structureStimulusSystemTechniquesTestingUrethral sphincterUrinary IncontinenceUrinary tract infectionUrodynamicsVertebral columnVeteransWorkafferent nerveclinical implementationcostexperimental studyfeasibility testinghospital readmissionimprovedinnovationmalepilot testpreservationpressurepreventprimary outcomerecruitrectalrenal damageresponseside effectsphincter ani muscle structure
中文摘要
背景:脊髓损伤(SCI)导致神经源性膀胱功能障碍,通常包括困难
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。
英文摘要
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.
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会议论文
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项目类别:
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资助金额:$27.49万
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依托单位:
海外基金