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)导致神经原性膀胱功能障碍,常伴有困难。
因逼尿肌-括约肌协同失调(DSD)而排空膀胱。当前的膀胱管理
策略包括导尿术、药物和/或手术,但这些干预措施不足以满足需要。
个人的需要。神经原性膀胱可通过以下方法排空:骶前根刺激(SARS)
在骶神经上植入电极以产生膀胱收缩。然而,这种清空可以是
被尿道括约肌的反射性收缩所阻碍。骶骨感觉神经根通常是横断的。
(切断根)以减少这些反射性收缩,但这种切断根也会损害理想的反射(例如,性
功能)和骶骨感觉(如果存在)。在动物身上的实验表明,在
600赫兹可以抑制尿路括约肌的活动,这是有潜力的。这种方法可以用来代替
切断膀胱根以提高膀胱排空效率。
目的:本研究的目的是测试600赫兹骶神经根治疗的可行性和潜在的疗效。
神经原性膀胱功能障碍患者限制尿道括约肌活动的刺激。我们
假设以600赫兹刺激骶神经根将导致较低的尿路括约肌压力。
对SARS通常使用的较低频率刺激的反应压力。
研究设计:在这项可行性研究中,我们将招募8名患有脊髓损伤和
已使用植入的骶根前路刺激来管理他们的膀胱。参与者将充当他们自己的角色
控制。尿路括约肌抑制的刺激波形将在临床实验室进行单次测试
会议。我们将不需要进行新的手术或植入程序。主要结果衡量标准是
尿道括约肌压力和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容量。
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
阻碍脊髓损伤患者的膀胱排空。我们可以改进促进膀胱的方法
通过消除对骶骨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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批准号:10459673
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项目类别:
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资助金额:$27.49万
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财政年份:2017
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依托单位:
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依托单位:
海外基金