In the United States, approximately 30% of reproductive aged women suffer from AUB and the associated symptom of heavy uterine bleeding (menorrhagia), a menstrual disorder that drastically impairs quality of life and has an annual economic burden of $37 billion. Women afflicted by AUB experience limitations in social, physical, and leisure activities, and incur a substantial personal financial burden due to work absence and home management costs (>$2,000 per year). Despite the high prevalence of this medical condition, clinicians rely on women who are distressed by their menses to give a subjective self-assessment of their menstrual blood loss (MBL), which has proven to be unreliable for accurate diagnosis and can lead to unnecessary surgery. Given that these symptoms account for one-third of all office visits to the gynecologist, choosing an appropriate treatment course is critical for providing high-quality care to Americans. Current methods for quantifying MBL have key drawbacks that limit their use. Alkaline hematin (AH) testing is the standard required by regulatory bodies for objective quantification of MBL. Unfortunately, AH testing is impractical for routine clinical practice as it is expensive (~$1000 per cycle) and has poor acceptability, requiring patients to collect all used sanitary products and mail them to a lab facility for analysis. While pictorial blood loss assessment charts (PBLACs) offer a less costly, semi-quantitative method for MBL quantification, they demonstrate a high rate of false positive results (~59%), which leads to the over-diagnosis of menorrhagia. To address the need for a cost-effective, easy- to-use, and objective method to quantify MBL in premenopausal women, TheraNova has developed a cell phone- based diagnostic tool, the electronic MBL Diary (eMBLD). Previously, in a proof of concept clinical study, we demonstrated a strong correlation between eMBLD and AH testing, the gold-standard method for objective quantification of MBL. The goals of this Phase II proposal are to determine the effectiveness of our device for accurately diagnosing menorrhagia. First, we will verify the sensitivity of the image processing algorithm to accurately quantify MBL in women with both normal and heavy menses (Specific Aim 1). Second, we will conduct a pivotal clinical study to validate the effectiveness of eMBLD for diagnosing menorrhagia (Specific Aim 2). The data obtained will support FDA 510(k) clearance and will allow us to commercialize the system within four years of the funding of this proposal.
Public Health Relevance Statement: Narrative Abnormal uterine bleeding (AUB) is a highly prevalent medical condition that is informed by unreliable and subjective assessments. Objective methods employed for quantification of menstrual blood loss (MBL) can be accurate, but they have limitations that have prevented their use in a routine clinical setting. We propose an inexpensive diagnostic tool to provide objective and accurate quantification of MBL.
Project Terms: Algorithms; Blood Stains; Blood Volume; Clinical Research; Clinical Study; Data Analyses; Data Analysis; data interpretation; Diagnosis; Disease; Disorder; Future; Goals; Gold; Hematin; Hemorrhage; Bleeding; blood loss; Hospitals; Hysterectomy; Laboratories; Lead; Pb element; heavy metal Pb; heavy metal lead; Leisure Activities; Light; Photoradiation; Menorrhagia; Hypermenorrhea; Menstruation; Menses; menstrual period; monthly period; Menstruation Disturbances; Menstrual Disorder; Menstruation Disorders; menstrual cycle disorder; Methods; Office Visits; physician office visit; Patients; Perception; Physicians; Pilot Projects; pilot study; Quality of life; QOL; Research; seal; Self Assessment; Sensitivity and Specificity; Computer software; Software; Specificity; Tampons; Testing; United States; Uterine hemorrhage; Uterine Bleeding; uterus bleeding; Woman; Work; base; image processing; Blood specimen; Blood Sample; Procedures; Image Analysis; Image Analyses; image evaluation; image interpretation; Area; Surface; Clinical; Phase; Medical; Series; Premenopause; Pre-Menopause; Pre-menopausal Period; Premenopausal; Premenopausal Period; pre-menopausal; Evaluation; Physical activity; Distress; Gynecologist; Measurement; Funding; Multicenter Studies; Multi-center studies; clinical Diagnosis; tool; Diagnostic; diaries; Unnecessary Surgery; Techniques; System; American; experience; basicity; alkalinity; Accuracy of Diagnosis; diagnostic accuracy; Participant; Devices; Reporting; social; Position; Positioning Attribute; reproductive; QOC; Quality of Care; portability; Cell Phone; Cellular Telephone; iPhone; smart phone; smartphone; Cellular Phone; preventing; prevent; Address; Symptoms; Data; Economic Burden; High Prevalence; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; cost; cost effective; aged; innovation; innovate; innovative; Impairment; commercialization; clinical practice; clinical decision-making; Algorithmic Analysis; Algorithmic Analyses; Analyses of Algorithms; Analysis of Algorithms; mobile application; mobile app; mobile device application; accurate diagnosis; associated symptom; co-morbid symptom; co-occuring symptom; comorbid symptom; concurrent symptom; cooccuring symptom; symptom association; symptom comorbidity; experimental study; experiment; experimental research; Financial Hardship; financial burden; financial distress; financial strain; financial stress; cost estimate; cost estimation; effectiveness evaluation; assess effectiveness; determine effectiveness; effectiveness assessment; evaluate effectiveness; effectiveness validation; validate effectiveness; accurate diagnostics; Home
