SPECTROPHOTOMETRIC EVALUATION OF VASCULOGENIC IMPOTENCE

血管性阳痿的分光光度评估

• 批准号: 2771378
• 负责人: GUIXIAN GAO
• 金额: $ 37.28万
• 依托单位: NEAR INFRARED MONITORING, INC. (NIM)
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-09-22 至 2000-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2771378
• 关键词: biomedical equipment development; blood flow measurement; blood volume; clinical research; computer program /software; diagnosis design /evaluation; fiber optics; hemodynamics; human subject; impotence; infrared spectrometry; male; male reproductive system disorder diagnosis; method development; noninvasive diagnosis; penis erection; vasodilators

The proposed research involves development of a specialized near infrared spectroscopy (NIRS) instrument for use as a diagnostic tool in evaluation of erectile dysfunction. The research represents an extension of work completed during the Phase I component of the project. The hypothesis being tested is that the dynamics of blood volume changes in the penis have diagnostic significance and that determination of these by a simple spectrophotometric technique will have an impact on the management of vasculogenic impotence. The specific aims of the Phase II study include refinements in design and construction of the NIRS instrument with a focus on its clinical applicability and simple use, and performance of extensive clinical studies to validate the technology. Refinements in optical probe design and simplification of instrument operation will be made to improve the practical use of the equipment along with development of simplified calibration methods and data analysis procedures. Objectives of the clinical studies include establishing the test-retest reliability, reproducibility, normative parameters, and cross validation of NIRS with other diagnostic techniques,commonly used for the evaluation of erectile dysfunction. The basic clinical protocol will involve the simultaneous use of NIRS and other diagnostic methods (nocturnal penile tumescence monitoring, color duplex ultrasonography, penile tonometry, and clinical assessments) to evaluate the extent and time course of blood volume changes during the erection cycle in both healthy volunteer subjects and in patients with various degrees of erectile dysfunction. Both pharmacological and physiological methods will be used for induction of penile erection, including intracavernous injections of vasodilators, visual sexual stimulation and sleep-related erections. Volunteer subjects will represent specified age ranges, and patients will include various specific etiologies for erectile dysfunction, including diabetes, cardiovascular disease, neurological disease, and non-organic (psychogenic) disease. Findings from these studies can be expected to determine the utility of NIRS as a means of diagnosing erectile dysfunction easily and effectively, thereby suggesting the widespread use of NIRS for this purpose. PROPOSED COMMERCIAL APPLICATIONS The proposed research will lead to development of a specialized NIRS instrument to be used both by general urologists in the professional office environment as well as specialists at male sexual dysfunction clinics for medical evaluation and management of erectile dysfunction.

拟议的研究涉及开发专门的NEAR 用于诊断的红外光谱仪(NIRS) 勃起功能障碍的评估工具。这项研究表明 在第一阶段期间完成的工作的延伸 项目。正在测试的假设是血液的动力学 阴茎的体积变化具有诊断意义， 用一种简单的分光光度技术测定这些物质 将对血管性阳萎的治疗产生影响。 第二阶段研究的具体目标包括改善 近红外光谱仪的设计与建造 临床适用性强，使用简单，性能广泛 临床研究以验证这项技术。光学方面的改进 探头的设计和仪器操作的简化 为提高设备的实际使用率而制造的 简化标定方法的发展和数据分析 程序。临床研究的目标包括 建立重测信度、重复性、 标准参数，以及近红外光谱与其他数据的交叉验证 诊断技术，通常用于勃起功能的评估 功能障碍。基本的临床方案将涉及 同时使用近红外光谱和其他诊断方法(夜间 阴茎肿胀监测、彩色双功超声 眼压测量和临床评估)，以评估范围和 勃起周期血容量变化的时间进程 无论是健康志愿者还是各种不同疾病的患者 勃起功能障碍的程度。药理上和药理上的 生理学方法将用于阴茎的诱导 勃起，包括海绵体内注射血管扩张剂， 视觉性刺激和与睡眠相关的勃起。义工 受试者将代表特定的年龄范围，患者将 包括勃起功能障碍的各种特定病因， 包括糖尿病，心血管疾病，神经疾病， 以及非器质性(心理)疾病。这些研究的发现 可以预期确定近红外光谱作为一种手段的效用 轻松有效地诊断勃起功能障碍，从而 这表明了近红外光谱在这方面的广泛使用。 建议的商业应用建议的研究将导致 一种专门的近红外光谱仪器的开发 专业办公室环境中的普通泌尿科医生也是如此 作为男性性功能障碍诊所的内科专家 勃起功能障碍的评估和处理。