Ultrasonic Techniques for Bladder Compliance Measurement

描述(申请人提供)：脊髓损伤神经原性膀胱患者的膀胱顺应性降低是常见的，并与多种不良后果有关，从令人烦恼的下尿路症状到危险的高逼尿肌存储压力并有可能导致肾功能衰竭。尿动力学研究(UDS)的一个组成部分--膀胱测压是目前评估膀胱顺应性的黄金标准，但这些研究具有侵入性、昂贵、耗时长、可能极不舒服，并存在临床副作用的风险。有必要开发替代的、非侵入性的方法来测量膀胱顺应性。这种方法在临床和研究中都是有用的。因此，本研究的目标是开发一种无创、定量、快速和敏感的方法来评估膀胱壁弹性，该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测振术(UBV)的技术来对膀胱进行非侵入性评估。本研究包括以下两个具体目的：目的1.评估膀胱顺应性的UBV测量与膀胱测压测量之间的一致性。这一目的的一般假设是，所提出的UBV方法可以提供与人体膀胱顺应性相关的新的、有用的信息。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的弹性测量结果将被用来与UDS的膀胱顺应性测量相关联。目的2.采用纵向研究方法，评价UBV测量作为预测新发脊髓损伤患者膀胱顺应性变化趋势的临床价值。其目的是验证一种假设，即膀胱的粘弹性参数及其随UBV测量的膀胱体积的变化可以在膀胱顺应性不佳或功能不良之前出现。为了验证这一假设，将进行一项纵向研究，定期对一组新的脊髓损伤患者进行UBV，这些患者具有顺应性膀胱，但有发展不顺应性膀胱的风险，因此，他们被安排定期(每年或每半年)进行包括UDS在内的膀胱评估。编辑的UBV结果将与临床结果进行比较，以确定UBV测量的变化是否比临床结果更早地预测膀胱功能障碍。阳性结果意味着UBV可以用于早期发现，从而加强对膀胱功能障碍的治疗。所提出的UBV方法具有新颖、无创、定量、快速、低成本、便携和适应当前超声技术的特点，只需更改软件即可，所有这些都意味着该技术可以很容易地转化为临床实践，并可在全球范围内广泛使用。此外，这一UBV提供了一组独特的关于膀胱的信息，这是以前没有的。这些信息可能有助于更早地发现并改善对膀胱功能障碍的管理。因此，该项目的成功完成可能会对膀胱功能障碍的诊断和治疗产生重大影响。

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.