Development of an electrical impedance myography (EIM) vaginal device for the evaluation of pelvic skeletal muscles

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1 Abstract 2 Bold Type is developing the “SenseWand”, a wireless pelvic floor diagnostic system (device and app) 3 to evaluate pelvic floor muscle health using electrical impedance myography (EIM). PFDs are complex 4 conditions (e.g. pelvic organ prolapse, stress urinary incontinence, high tone pelvic floor dysfunction) that impact 5 millions of women worldwide. It is estimated that PFDs will affect up to 50% of women older than 50 years. Risk 6 factors include pregnancy, childbirth, obesity, aging, and genetic predisposition, though the pathogenesis 7 continues to be poorly understood. Consequently, PFDs are associated with significant health care expenditure 8 due to lack of preventive measures, high failure rate of current interventions, and the need for retreatments. The 9 skeletal pelvic floor muscles (PFMs) support the pelvic and abdominal viscera and injury and dysfunction play a 10 role in PFDs. These disorders require considerable ongoing evaluation to be managed effectively in symptomatic 11 patients. Current diagnostic methods are limited, and no noninvasive diagnostic methods are available to 12 evaluate PFM quality. Specifically, we currently lack diagnostic tools to help clinicians better diagnose 13 and treat patients with PFDs. 14 We propose development and evaluation of the “SenseWand”, a wireless pelvic floor diagnostic system 15 (device and app) to evaluate pelvic floor muscle health using EIM. EIM applies weak, non-detectable, 16 multifrequency electrical currents to a muscle (or muscle group) through two excitation electrodes, and resulting 17 voltages are measured via two sense electrodes. Measurements are fast (<2 s/muscle), simple to perform, 18 quantitative, and highly repeatable. Parameters extracted from these measurements correlate strongly with 19 different neuromuscular conditions and sensitively track muscle health and disease progression. Multiple studies 20 have demonstrated wide application potential for EIM in a variety of fields in which muscle injury or dysfunction 21 occurs. EIM could have a particular impact in the assessment of pelvic floor muscles, where its rapid, 22 quantitative and painless nature is especially important. 23 Bold Type is a product development firm specializing in connected, wireless medical devices. Our team has 24 decades of product development experience with expertise in medical devices, quality, and regulatory affairs. 25 We have developed proprietary hardware and software development kits that allow us to design and implement 26 medical devices efficiently by leveraging reusable subsystems that are designed and documented to comply with 27 FDA regulations. Building off these resources we propose the following Specific Aims: 1) Develop a prototype of 28 the “SenseWand”: a wireless, intravaginal EIM device. 2) Validate the SenseWand in 10 postmenopausal women 29 with symptomatic anterior compartment prolapse and 10 premenopausal nulliparous controls. 3) Evaluate 30 SenseWand against an FDA cleared, non-vaginal bioimpedance system (SFB7) to validate its accuracy.