Clinical Feasibility of Wireless Catheter-Free Urodynamics for Extended, Comprehensive Urological Evaluation in the Home Setting
无线无导管尿动力学在家庭环境中进行扩展、综合泌尿外科评估的临床可行性
基本信息
- 批准号:10762486
- 负责人:
- 金额:$ 5.4万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-03-01 至 2024-07-31
- 项目状态:已结题
- 来源:
- 关键词:AddressAdoptedAffectAmericanAnxietyAwardBenign Prostatic HypertrophyBladderCareer MobilityCathetersClinicalClinical ManagementClinical ResearchDevicesDiagnosisDiagnosticDistressEntrepreneurshipError SourcesEvaluationFailureFunctional disorderFutureGoalsHealthHomeHome environmentLeadershipLiquid substanceLower urinary tractMedicalMedical DeviceMentorsMonitorNeurogenic BladderOutcomes ResearchOveractive BladderParentsPatientsPerformancePhasePhysiologicalPre-Clinical ModelRectumResolutionRoleSafetySpecificitySymptomsSystemTechnologyTestingTimeUrinary IncontinenceUrodynamicsUrologistWorkcommercializationcostdetrusor underactivitydiagnostic accuracydiagnostic strategydiagnostic valueeconomic outcomehuman subjectimprovedoptimal treatmentspressurerectalsafety and feasibilitysensorskillsurinaryurologicwireless
项目摘要
ABSTRACT
Urodynamics (UDS) evaluations are conducted to aid in diagnosis and treatment of patients with Lower Urinary
Tract Dysfunction (LUTD). Although conventional UDS (cUDS) is the current objective standard, up to 46% of
UDS evaluations fail to replicate the patient’s symptoms. This failure is primarily due to the lack of physiological
relevance of the study itself. The placement of a urinary catheter, a rectal catheter, retrograde filling of the bladder
during pressure-flow studies, and the patient discomfort and anxiety involved in the study have all been identified
as sources of error and have confounded the diagnostic accuracy of cUDS. Thus, the study is fundamentally
flawed due to limitations of technology, and only provides a snapshot of bladder performance in an artificially
controlled setting. Therefore, there is a clinical need for a diagnostic study that can accurately reproduce patient
symptoms to identify patients with detrusor underactivity and enable Urologists to plan their treatment path
accordingly. While ambulatory UDS (aUDS) has shown promise, the presence of both a urinary and rectal
catheter continue to confound the diagnostic capabilities of the system. In addition, allowing for natural filling
removes the clinician’s ability to precisely monitor the amount of fluid in the bladder, which can impact the
specificity of this approach. While aUDS is an improvement over cUDS, it has not been widely adopted due to
the complexity of the study, the time demand, and the technical failure rate of these systems. Therefore, there
is a clear clinical need for a wireless, catheter-free UDS that provides a more physiologically relevant and natural
assessment of bladder function. To address this need, Bright Uro has developed the UroMonitor to provide high-
resolution information about bladder function under more physiologically relevant conditions to better replicate
patient symptoms and improve diagnostic accuracy. The UroMonitor has been tested in both preclinical models
and human subjects and has shown a concordance with cUDS during simultaneous assessment of 0.874, with
high accuracy and precision. The overall goal of the parent Phase II award is to demonstrate the safety and
clinical feasibility of the UroMonitor in a rigorous, pivotal study. In the parent award, we are optimizing the
UroMonitor to include pressure sensing and improve device performance for clinical use (Specific Aim 1).
Subsequently, we will evaluate the safety and feasibility of the UroMonitor for extended urological monitoring in
the home environment (Specific Aim 2). In the present supplement, we have assigned Dr. Brittany Carter,
Director of Clinical Affairs, a clinical research management role in the project and will support her
entrepreneurship skills to ultimately allow her to advance her career in clinical leadership within the Medical
Device startup space. She will manage the clinical study led by PD/PI and mentor Mr. Derek Herrera and develop
and execute clinical strategies and health and economics outcomes research to support future commercialization
of the UroMonitor. The proposed work for Brittany will be performed within the overall scope of the parent award.
摘要
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Derek Herrera其他文献
Derek Herrera的其他文献
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{{ truncateString('Derek Herrera', 18)}}的其他基金
Clinical Feasibility of Wireless Catheter-Free Urodynamics for Extended, Comprehensive Urological Evaluation in the Home Setting
无线无导管尿动力学在家庭环境中进行扩展、综合泌尿外科评估的临床可行性
- 批准号:
10384381 - 财政年份:2021
- 资助金额:
$ 5.4万 - 项目类别:
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