FEMALE SEXUAL DYSFUNCTION DIAGNOSTIC TOOL DEVELOPMENT

女性性功能障碍诊断工具的开发

• 批准号: 7687569
• 负责人: Wendelin L. Sachtler
• 金额: $ 33.01万
• 依托单位: CORPORA SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-30 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7687569
• 关键词: Address; Adverse effects; American; American Medical Association; Americas; Anxiety; Arousal; Basic Science; Bladder; Blood; Body of uterus; Clinical; Clinical Research; Clinical Trials; Clinical assessments; Collection; Complex; Computer software; Custom; Data; Diabetes Mellitus; Diagnosis; Diagnostic; Disease; Ensure; Erectile dysfunction; Evaluation; Event; Feedback; Female; Foundations; Gender; Genital system; Goals; Gold; Health; Heart Diseases; Hypertension; Impairment; Indiana; International; Journals; Life; Light; Measurement; Measures; Methods; Modification; Monitor; Morbidity - disease rate; Nature; Nurses; Operating System; Optics; Orgasm; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Phase I Clinical Trials; Physiological; Physiological Processes; Postmenopause; Process; Production; Publishing; Quality of life; Regulation; Reporting; Reproduction; Research; Research Institute; Sampling; Self Assessment; Sex Functioning; Sexual Arousal; Sexual Dysfunction; Somatotype; Source; Staging; Surveys; System; Tactile; Temperature; Testing; Time; Universities; Vagina; Weight; Woman; base; clinical practice; data acquisition; depressive symptoms; design; direct application; experience; improved; instrument; men; optical sensor; pressure; prototype; public health relevance; reproductive; response; sensor; sex; social; tool; tool development

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.

描述（由申请人提供）：1999年发表在《美国医学会杂志》上的一项全国健康和社会生活调查表明，43%的美国妇女在一生中遇到生殖反应问题。尽管患有这种疾病的妇女明显多于男子，但妇女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界定和衡量女性疾病。与勃起功能障碍相似，这些疾病可以作为孤立的身体损害或糖尿病，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，或作为滥用的结果出现，作为抑郁或焦虑的症状，或作为治疗这些疾病的各种药物的副作用。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存在未满足的需求。这是一个根本的缺点，因为生殖反应的特点是复杂的相互作用的生理过程。不同的疾病可以表示为在一个生理指标中发生而不是另一个生理指标的异常，或者在时间上重叠的几个指标中发生的异常。目前的方法仍然严重依赖于患者的自我评估和报告，这些疾病的私人性质进一步阻碍了可靠和可重复数据的收集。用于收集生理反应的几个选项是（1）功能有限，（2）在许多类型的常规功能期间不可用，以及（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。语料库系统旨在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。在第一阶段开发的原型的临床试验成功地证明了其基本疗效。在第二阶段，将进一步开发该仪器，为商业生产做准备。将进行临床试验以验证测量的因素。 公共卫生相关性 在美国，大约有5000万妇女在一生中的某个时候受到性问题的困扰，这些情况仍然知之甚少。该仪器将通过极大地改善与性功能相关的生理反应的测量，大大推进女性性功能障碍（FSD）的研究和潜在治疗。因此，该工具将通过为改进诊断和治疗方法提供基础，对数百万妇女的生活质量产生重大影响。