Research Project
9679105
SUMMARY Pelvic organ prolapse (POP) is a highly prevalent condition affecting at least 50% of women in the US during their lifetimes. Urinary incontinence (UI), as found in the US survey, affects from 15% to 38% of women. The true etiology of POP and UI and variations seen among individuals are not entirely understood. These disorders are thought to share a common pathogenesis, weakening (elasticity changes) of the muscular and connective support tissues, and pelvic floor muscle dysfunctions. Further progress in women's healthcare is possible if a patient with a damaged pelvic floor could undergo medical imaging and biomechanical diagnostic tests; the results of which could be fed into a patient-specific assessment and optimal treatment for that patient. In this project, we propose to develop and clinically validate a new approach for biomechanical characterization of structure components (ligaments, muscles, and fasciae) in the female pelvic floor. It will be based on a new device for Tactile + Ultrasound Imaging to allow static, dynamic (under tissue deformation) and functional (muscle contraction) characterization of the female pelvic floor. Tactile and ultrasound imaging fusion has a special fundamental importance because of the complementary nature of these technologies: tactile images provide stress data and ultrasound images provide strain data for the same region during tissue deformation. This allows elasticity assessment as a stress to strain ratio - physical parameter of tissue with high sensitivity to the pathology development. In the Phase I research, we plan development of a device ?-prototype and validation of its imaging performance in a pilot clinical study with 20 subjects at two clinical sites.
