Tactile and ultrasound imaging fusion for functional assessment of the female pelvic floor

Summary Pelvic organ prolapse (POP) is a highly prevalent condition affecting 40-50% of women in the US during their lifetimes. Urinary incontinence (UI) affects up to 48% of women. Both POP and UI are more common in women than in men, and their prevalence is increased with age. Beyond the physical and the quality of life impacts, these conditions cause significant morbidity. The true etiology of POP and UI and their variations observed among individuals is not entirely understood. These disorders are thought to share common pathogeneses, weakening (elasticity changes) of the connective support tissues and pelvic floor muscle dysfunction. The lifetime surgery risk for either UI or POP in women is about 20% by the age of 80 years. A POP surgical failure rate of 61.5% for uterosacral ligament suspension and 70.3% for sacrospinous ligament fixation groups in a representative study was reported. Substantial improvement is possible if patients with the diseased pelvic floor conditions undergo imaging and biomechanical diagnostic tests; the results of which could be fed into a patient-specific optimal treatment. In the Phase I research, a conceptual α-prototype of a vaginal tactile and ultrasound imaging probe was designed and its imaging performance demonstrated in a pilot study. Tactile (stress) and ultrasound (anatomy, strain) image fusion furnishes new insights into the female pelvic floor conditions through biomechanical mapping in multiple tests. In Phase II, we will design and build a pre- production β-prototype of a Vaginal Tactile Ultrasound Imager (TIUSv), which will incorporate the Phase I lessons in product development process. We will verify it via bench testing, validate it in a multi-site clinical study, prepare and submit a 510(k) application to the FDA.