Ultrasonic Techniques for Bladder Compliance Measurement

描述（由申请人提供）：膀胱顺应性降低在脊髓损伤的神经源性膀胱患者中很常见，并与多种不良结局相关，从令人烦恼的下尿路症状到危险的高逼尿肌储尿压力，可能导致肾衰竭。膀胱测压是尿动力学研究（UDS）的一个组成部分，是目前评估膀胱顺应性的金标准，但这些研究是侵入性的，昂贵的，时间密集的，可能非常不舒服，并具有临床副作用的风险。需要开发用于测量膀胱顺应性的替代的非侵入性方法。这种方法在临床和研究上都是有用的。因此，本研究的目的是开发一种无创的，定量的，快速的，和敏感的方法来评估膀胱壁的弹性，这些信息可以用来评估膀胱的顺应性。为了解决这个问题，我们提出了一种技术，称为超声膀胱振动（UBV）的膀胱无创评估。本研究包括以下两个具体目标：目标1。评估膀胱顺应性的UBV测量和膀胱测压测量之间的一致性。该目的中的一般假设是所提出的UBV方法可以提供与人类受试者中的膀胱顺应性相关的新的有用信息。为了检验这一假设，将对一组接受UDS的脊髓损伤神经源性患者进行UBV。通过UBV测量的弹性结果将用于与膀胱顺应性的UDS测量相关联。目标二。在新发脊髓损伤患者中，采用纵向研究方法评价UBV测量作为膀胱不依从趋势预测因子的临床价值。本研究的目的是检验膀胱的粘弹性参数及其变化与膀胱体积的关系（通过UBV测量）可以预测膀胱的不顺应性或功能不良的假设。为了检验这一假设，将进行一项纵向研究，其中将对一组新的脊髓损伤患者定期进行UBV，这些患者具有顺应性膀胱，但有发展为非顺应性膀胱的风险，因此，他们计划定期（每年或每半年）进行膀胱评价，包括UDS。将编译的UBV结果与临床结果进行比较，以确定UBV指标的变化是否比临床结果更早预测膀胱功能障碍。一个积极的结果意味着UBV可以用于早期检测，从而加强膀胱功能障碍的治疗。所提出的UBV方法是新颖的、非侵入性的、定量的、快速的、低成本的、便携式的，并且仅通过软件改变而适应于当前的超声技术，所有这些都意味着该技术可以容易地转化为临床实践并且可用于全球的大量患者群体。此外，该UBV提供了一组以前不可用的关于膀胱的独特信息。这些信息可能会导致膀胱功能障碍的早期检测和改善管理。因此，成功完成本项目可能对膀胱功能障碍的诊断和管理产生重大影响。

DESCRIPTION (provided by applicant): Reductions in bladder compliance are common in spinal cord injured patients with neurogenic bladder and are associated with multiple adverse outcomes ranging from bothersome lower urinary tract symptoms to dangerously high detrusor storage pressures with the potential for renal failure. Cystometry, a component of Urodynamic Study (UDS) is the current gold standard for assessing bladder compliance, but these studies are invasive, expensive, time intensive, can be extremely uncomfortable, and carry a risk of clinical side effects. There is a need for the development of alternate, noninvasive methods for measuring bladder compliance. Such a method would be useful both clinically and for research. Thus, the goal of this study is to develop a noninvasive, quantitative, rapid, and sensitive method for evaluation of bladder wall elasticity where this information can be used to assess bladder compliance. To address this problem, we propose a technique called Ultrasound Bladder Vibrometry (UBV) for noninvasive assessment of bladder. This study includes the following two Specific Aims: Aim 1. Estimate concordance between UBV measures and cystometry measures of bladder compliance. The general hypothesis in this Aim is the proposed UBV method can provide new, useful information that relates to bladder compliance in human subjects. To test this hypothesis, UBV will be performed on a select group of spinal cord injured neurogenic patients undergoing UDS. Results of elasticity measures by UBV will be used to correlate to the UDS measures of bladder compliance. Aim 2. Evaluate the clinical value of UBV measures as a predictor of bladder non-compliance trend using a longitudinal study approach in patients with new spinal cord injury. The goal of this Aim is to test the hypothesis that viscoelastic parameters of the bladder and their variations versus bladder volume, as measured by UBV, can predate noncompliance or poor function of bladder. To test this hypothesis, a longitudinal study will be conducted in which UBV will be performed periodically on a group of new spinal cord injured patients who have compliant bladder but are at risk for developing non-compliant bladder, and for this reason, they are scheduled for periodic (annual or semiannual) bladder evaluations including UDS. Compiled UBV results will be compared against the clinical findings to determine if variations in UBV measures predict bladder dysfunction earlier than clinical findings. A positive outcome means that UBV can be used for early detection and hence enhanced treatment of bladder dysfunction. The proposed UBV method is novel, noninvasive, quantitative, fast, low cost, portable, and adaptable to current ultrasound technology with only software changes, all of which mean that this technique can be readily translated into clinical practice and become available to a large patient population worldwide. Additionally, this UBV provides a unique set of information about bladder that has not been available before. This information can potentially lead to earlier detection and improved management of bladder dysfunction. Thus, successful completion of this project may have a significant impact in diagnosis and management of bladder dysfunction.