Ultrasonic Techniques for Bladder Compliance Measurement

描述（由申请人提供）：膀胱依从性降低在神经源性膀胱脊髓损伤患者中很常见，并与多种不良后果相关，从恼人的下尿路症状到危险的高逼尿肌储存压力，并可能导致肾功能衰竭。膀胱测量是尿动力学研究（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，并且有临床副作用的风险。有必要发展替代的，无创的方法来测量膀胱顺应性。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、定量、快速和敏感的方法来评估膀胱壁弹性，这些信息可用于评估膀胱顺应性。为了解决这个问题，我们提出了一种称为超声膀胱振动测量（UBV）的技术，用于膀胱的无创评估。本研究包括以下两个具体目的：目的1。估计超紫外线测量与膀胱顺应性测量之间的一致性。本研究的一般假设是，所提出的UBV方法可以提供与人类受试者膀胱顺应性有关的新的有用信息。为了验证这一假设，将对一组接受UDS的脊髓损伤神经源性患者进行UBV。UBV弹性测量结果将用于与UDS膀胱顺应性测量相关联。目标2。在新发脊髓损伤患者中，采用纵向研究方法评估UBV测量作为膀胱不顺应性趋势预测因子的临床价值。该目的的目的是验证膀胱粘弹性参数及其随膀胱体积变化的假设，如UBV测量，可以早于膀胱不合规或功能不良。为了验证这一假设，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，这些患者有膀胱顺应性，但有发展为膀胱不顺应性的风险，因此，他们将定期（每年或半年）进行膀胱评估，包括UDS。将编译的uvb结果与临床结果进行比较，以确定uvb测量的变化是否比临床结果更早地预测膀胱功能障碍。一个积极的结果意味着UBV可以用于早期发现，从而加强膀胱功能障碍的治疗。该方法具有新颖、无创、定量、快速、低成本、便携、适用于当前超声技术的特点，只需对软件进行更改，所有这些都意味着该技术可以很容易地转化为临床实践，并为全世界的大量患者提供服务。此外，这种uvb提供了一套独特的关于膀胱的信息，这是以前没有的。这些信息可能会导致早期发现和改善膀胱功能障碍的管理。因此，本课题的成功完成可能对膀胱功能障碍的诊断和治疗有重要的影响。

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.