FEMALE SEXUAL DYSFUNCTION DIAGNOSTIC TOOL DEVELOPMENT

描述（由申请人提供）：1999年《美国医学协会杂志》上发表的一项全国健康和社会生活调查表明，43%的美国妇女在其一生中经历过生殖反应性问题。尽管受这类疾病困扰的女性明显多于男性，但针对女性的诊断和治疗选择相对较少。造成这种差异的一个原因是难以定义和衡量女性疾病。与勃起功能障碍类似，这些障碍可以作为单独的身体损害存在，也可以作为糖尿病、心脏病或高血压的合并症存在。此外，它们可以作为更年期和产后的正常部分发生，也可以作为虐待的结果，作为抑郁或焦虑的症状，或作为治疗这些病症的各种药物的副作用而发生。在研究、药物试验和临床实践中，对测量与生殖反应性相关的生理事件的仪器的需求尚未得到满足。这是一个根本的缺点，因为生殖反应的特点是生理过程的复杂相互作用。不同的疾病可以表现为一种生理指标出现异常，而另一种生理指标没有出现异常，或者几个指标在时间上重叠。目前的方法仍然严重依赖于患者的自我评估和报告，这些疾病的私密性进一步阻碍了可靠和可重复数据的收集。收集生理反应的几种选择：(1)功能有限，(2)在许多类型的正常功能中不可用，(3)必须在临床环境中使用。由于这些限制，缺乏良好的规范性数据。Corpora Systems的目标是开发和测试一种产品，该产品将开始解决这三个缺陷，并成为研究和药物试验的标准工具，具有用于诊断和绘制治疗进展图表的潜力。第一阶段的临床试验成功地证明了它的基本功效。在第二阶段，该仪器将进一步发展，为商业化生产做准备。将进行临床试验来验证测量的因素。

DESCRIPTION (provided by applicant): A 1999 National Health and Social Life Survey published in the Journal of the American Medical Association indicated that 43% of American women experience problems with reproductive reactivity in the course of their lives. Despite the fact that significantly more women than men are afflicted with such disorders, there are comparatively few diagnostic and treatment options for women. A reason for this discrepancy is the difficulty of defining and measuring female disorders. Similar to erectile dysfunction, these disorders can exist as an isolated physical impairment or as a co-morbidity of diabetes, heart disease, or hypertension. In addition, they can occur as a normal part of menopause and post-partum, or arise as a consequence of abuse, as a symptom of depression or anxiety, or as a side effect from the various medications treating these conditions. There is an unmet need in research, pharmaceutical trials, and clinical practice for instruments to measure physiological events associated with reproductive reactivity. This is a fundamental shortcoming since reproductive reactivity is characterized by a complex interplay of physiological processes. Different disorders can be expressed as anomalies that occur in one physiological indicator but not another, or in several indicators that overlap in time. Current methods remain heavily dependent on patient self-assessment and reporting, and the private nature of these disorders further hinders the collection of reliable and repeatable data. The few options for collecting physiological response are (1) of limited functionality, (2) not usable during many types of regular functioning, and (3) must be used in a clinical setting. Because of these limitations, there is a lack of good normative data. Corpora Systems aims to develop and test a product that will begin to address these three deficits and become a standard tool for research and pharmaceutical trials, with the potential for use in diagnosis and charting of treatment progress. Clinical trials of the prototype developed in Phase I successfully demonstrated its fundamental efficacy. In Phase II, the instrument will be developed further to prepare for commercial production. Clinical trials will be performed to validate the measured factors. PUBLIC HEALTH RELEVANCE Approximately 50 million women in America are afflicted with sexual problems at some point in their lives, and these conditions are still poorly understood. The proposed instrument will significantly advance research and potential treatments for Female Sexual Disorders (FSD) by greatly improving measurement of physiological responses associated with sexual function. The instrument will thus have significant impact on the quality of life of millions of women by providing the foundation for improved diagnostic and treatment methods.