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.
