SBIR-STTR Award

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.

Public Health Relevance Statement:
NARRATIVE This project targets the development a new device for real time fusion of tactile imaging and ultrasound imaging to provide static, dynamic (under tissue deformation) and functional (muscle contraction) imaging and characterization of female pelvic floor prolapse and urinary incontinence conditions, which are common among women and require accurate diagnostics due to complexity of these disorders.

Project Terms:
Affect; Age; Algorithmic Software; Anterior; Area; base; biomaterial compatibility; Biomechanics; Bladder; Caring; Clinical; Clinical Data; Clinical Research; clinical research site; Data; data acquisition; Databases; design; Development; Development Plans; Devices; Diagnostic; Diagnostic tests; Disease; Elasticity; Electromagnetics; Electronics; Elements; Etiology; Female; Functional disorder; Goals; Healthcare; Image; imaging software; Individual; Legal patent; lifetime risk; Ligaments; Measurement; Medical Imaging; men; Modulus; Morbidity - disease rate; Muscle; Muscle Contraction; Nature; novel strategies; off-patent; Operative Surgical Procedures; optimal treatments; Pathogenesis; Pathology; Patients; Pelvic Floor Muscle; Pelvic floor structure; pelvic organ prolapse; Performance; Phase; pressure; Prevalence; Protocols documentation; prototype; Ptosis; Quality of life; Rectum; Recurrence; Reporting; Reproducibility; Research; Resolution; Risk; Safety; sensor; Side; Signal Transduction; Social Conditions; Software Design; Stress; Structure; surgical risk; Surveys; System; Tactile; Technology; temporal measurement; Test Result; Testing; Time; TimeLine; Tissue Model; Tissues; Ultrasonography; Urinary Incontinence; Vagina; Validation; Variant; verification and validation; Woman

Pelvic organ prolapse (POP) is a highly prevalent condition affecting 40-50% of women in the US during theirlifetimes. Urinary incontinence (UI) affects up to 48% of women. Both POP and UI are more common in womenthan 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 observedamong 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. Thelifetime surgery risk for either UI or POP in women is about 20% by the age of 80 years. A POP surgical failurerate of 61.5% for uterosacral ligament suspension and 70.3% for sacrospinous ligament fixation groups in arepresentative study was reported. Substantial improvement is possible if patients with the diseased pelvicfloor conditions undergo imaging and biomechanical diagnostic tests; the results of which could be fed into apatient-specific optimal treatment. In the Phase I research, a conceptual α-prototype of a vaginal tactile andultrasound 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 floorconditions 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 Ilessons in product development process. We will verify it via bench testing, validate it in a multi-site clinicalstudy, prepare and submit a 510(k) application to the FDA.

Public Health Relevance Statement:
Narrative 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. Beyond the physical and the quality of life impacts, these conditions cause significant morbidity. 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 high level of POP surgical failure rate 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 unique probe capable of vaginal tactile and ultrasound imaging was designed and its safety and imaging performance demonstrated in a feasibility study with 20 urogynecologic patients. The main goal of Phase II is to conduct validation clinical studies with an improved Vaginal Tactile Ultrasound Imager and submit an FDA application. Tactile (stress) and ultrasound (anatomy, strain) image fusion opens new insights into the female pelvic floor conditions through biomechanical mapping.

Project Terms: