Portable Standardization Tool for Erectile Dysfunction

描述(申请人提供)：勃起功能障碍影响3000万美国男性。尽管近年来在手术和非手术方面取得了重要进展，但病情的诊断、病情进展的图表和治疗反应的记录仍然是非标准化的，严重依赖于患者的自我评估和报告。由于对触觉和视觉输入刺激的选择不一致，而且往往是特殊的，功能评估进一步复杂化。勃起功能障碍的私密性也阻碍了在临床环境中收集可靠和可重复的数据。拟议的研究是为了开发和测试一种将解决这些当前缺陷的产品。将在三个领域取得技术进步：(1)刺激标准化，(2)同时实时收集肿胀、僵硬、温度、血压和心率的数据，以及(3)将所有传感和执行元件集成到一个紧凑的封装中，以便于携带和使用。该产品将通过使用已知和可重复的刺激，在诊断和治疗开始时建立基线反应，并将使西地那非等新药和其他与勃起功能障碍有关的治疗方法的临床试验标准化。到目前为止，Corporation Systems已经证明了新技术的关键方面的有效性，并寻求充分开发这些单独的组件，并将其集成到具有额外生理测量功能的单个设备中。第一阶段的资金将使综合系统的运行原型做好概念验证测试的准备。这些原型将包括将在整个项目过程中开发的测量系统的子集。为了确认功能性和安全性，将在健康人群上进行I期临床试验，特别是评估刺激效果和患者对该产品的接受度。刺激的开发和表征将是这一阶段的关键因素，以补充设备原型独特的刺激产生能力。在第二阶段，将根据前一阶段的评估改进功能。添加的组件将完成系统，并为商业生产做准备。对受影响人群的试验，以及对健康人群的额外试验，将允许与目前勃起功能障碍的标准测量相关联。最后，将探索使该产品适用于在家对患者进行远程、基于互联网的评估的机会。

DESCRIPTION (provided by applicant): Erectile dysfunction affects 30 million American men. Despite important surgical and non-surgical advances in recent years, diagnosis of the condition, charting of its progression, and documentation of response to treatment remain non-standardized and heavily dependent upon patient self-assessment and reporting. Functional evaluation is further complicated by inconsistent and often idiosyncratic selection of tactile and visual input stimuli. The private nature of erectile dysfunction also hinders the collection of reliable and repeatable data in a clinical setting. The proposed research is to develop and test a product that will address these current deficits. Technological advancements will be created in three areas: (1) stimulus standardization, (2) simultaneous real-time data collection of tumescence, rigidity, temperature, blood pressure, and heart rate, and (3) integration of all sensing and actuation elements into one compact package for portability and ease of use. The product will allow the establishment of a baseline response at the onset of diagnosis and treatment through use of known and repeatable stimuli, and will enable the standardization of clinical trials for new drugs, such as sildenafil, and other treatments related to erectile dysfunction. To date Corpora Systems has demonstrated the efficacy of key aspects of the novel technologies, arid seeks to fully develop and integrate these individual components into a single device together with additional physiological measurement capabilities. Phase I funding will result in functioning prototypes of the integrated system ready for proof of concept testing. These prototypes will include a subset of the measurement systems that will be developed over the full course of the project. To confirm functionality and safety, Phase I clinical trials will be conducted on a healthy population, specifically to evaluate stimulus efficacy and patient acceptance of the product. Development and characterization of stimuli will be a key factor in this phase, in order to complement the unique stimulus generation capabilities of the device prototypes. In Phase II, features will be refined based on the evaluation during the preceding Phase. Added components will complete the system and prepare for commercial production. Trials on an affected population, together with additional trials on a healthy population, will permit correlation with current standard measures of erectile dysfunction. Finally, opportunities will be explored to adapt the product for remote, internet-based assessment of patients at home.