SPECTROPHOTOMETRIC EVALUATION OF VASCULOGENIC IMPOTENCE

拟议的研究涉及开发一种专门的近 红外光谱（NIRS）仪器，用作诊断 勃起功能障碍的症状有哪些该研究代表了 第一阶段期间完成的工作的延长 项目正在测试的假设是血液的动力学 阴茎体积变化具有诊断意义， 通过简单的分光光度技术测定这些 将对血管性阳痿的治疗产生影响。 第二阶段研究的具体目标包括： 设计和建设的近红外光谱仪，重点是其 临床适用性强，使用简单，性能广泛 临床研究来验证这项技术。优化光学性能 探头设计和仪器操作的简化将是 沿着改进设备的实际使用， 制定简化的校准方法和数据分析 程序.临床研究的目的包括 建立重测信度，再现性， 规范性参数，并与其他NIRS交叉验证 诊断技术，通常用于评估勃起 功能障碍基本临床方案将涉及 同时使用NIRS和其他诊断方法（夜间 阴茎肿胀监测，彩色双功超声，阴茎 眼压测量和临床评估），以评估 勃起周期中血容量变化的时间过程 健康志愿者受试者和患有各种 勃起功能障碍的症状药理学和 将使用生理方法诱导阴茎 勃起，包括海绵体内注射血管扩张剂， 视觉性刺激和睡眠性勃起志愿 受试者将代表指定的年龄范围，患者将 包括勃起功能障碍各种特定病因， 包括糖尿病、心血管疾病、神经系统疾病 非器质性（心因性）疾病。这些研究的结果 可以预期确定NIRS作为一种手段的效用， 容易有效地诊断勃起功能障碍，从而 这表明NIRS广泛用于此目的。 拟议的商业应用拟议的研究将导致 开发一种专门的NIRS仪器， 一般泌尿科医生在专业的办公室环境，以及 作为男性性功能障碍诊所的专家， 勃起功能障碍的诊断和治疗

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.