WASHINGTON--(BUSINESS WIRE)--AUGS PFD Week 2024 booth 611—Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, announced that researchers have identified a potential machine learning model clinicians could use to create personalized treatments for female pelvic floor disorders. Based on an analysis of over 600 real-world patients, researchers from Massachusetts General Hospital, Massachusetts Institute of Technology, and Axena Health used machine learning to identify trends that may enable clinicians to personalize first-line treatment for female urinary incontinence and improve the identification of patients who may need advanced treatments such as sacral neuromodulation. The abstract authors will present the data in an oral abstract on Thursday October 24 at 3:55 pm at PFD Week 2023, the American Urogynecologic Society (AUGS) annual scientific meeting in Washington, DC. Researchers used the Leva® Pelvic Health System in the study.
In the abstract, “Predicting success in women undergoing first-line treatment for urinary incontinence,” researchers applied advanced machine learning techniques to various predictors, including demographic information (age, BMI, race/ethnicity), baseline symptoms, and data captured by the Leva System within 14 days of first use. An analysis of these trends allowed researchers to predict the probability of treatment success using multiple machine learning techniques. Ultimately, the Random Forest model proved the best fit, accurately predicting outcomes 78% of the time. This finding was externally validated using a separate data set. This data can be used to identify patients who might benefit from additional coaching support or a change in their regimen to optimize outcomes.
“Our research team endeavored to create a model that can be used to improve treatment outcomes for women with urinary incontinence,” said Samantha J. Pulliam, MD, chief medical officer for Axena Health. “By applying advanced machine learning techniques to various data, including information from the Leva System, we were able to observe trends that allowed us to predict treatment outcomes using the current treatment regimen. We believe this discovery will help clinicians develop personalized treatment plans based on data that can predict which treatment would be most effective, could potentially save time and costs and most importantly, support symptom relief for more women.”
The abstract authors include:
Aria Eppinger
Massachusetts Institute of Technology
Milena M. Weinstein, MD
Associate Professor of Obstetrics and Gynecology, Harvard Medical School
Chief of Urogynecology and Reconstructive Pelvic Surgery (URPS)
Co-chair, Center for Pelvic Floor Disorders
Director of Research, Urogynecology and Reconstructive Pelvic Surgery Fellowship
Massachusetts General Hospital
Samantha J. Pulliam, MD, URPS
Assistant Professor, Tufts Medical School, Department of Obstetrics and Gynecology
Chief Medical Officer, Axena Health, Inc.
Alexander Melamed MD, MPH
Associate Professor of Obstetrics, Gynecology, and Reproductive Medicine
Harvard Medical School
Gynecologic Oncologist, Massachusetts General Hospital
“Axena Health is focused on improving the standard of care for women’s pelvic health,” said CEO Randy Pritchard. “While that means we’re committed to ensuring that we amass the best, most rigorous data in medicine behind the Leva System, it’s also important to us that women receive the treatment for urinary incontinence that’s right for them. We applaud the researchers’ novel use of machine learning to create a model that can help clinicians predict the probability of treatment success, which is an important part of improving outcomes for care-seeking women.”
PFD Week 24 attendees can learn more about the Leva System by visiting Axena Health at booth #611.
About the Leva® Pelvic Health System
The Leva® Pelvic Health System offers an innovative, non-invasive, medication-free way for women to train and strengthen their pelvic floor muscles—at home in just five minutes a day—to treat urinary incontinence (UI) and chronic fecal incontinence (FI). Combining a small FDA-cleared vaginal motion sensor with integrated software, the Leva System offers precise visualization of pelvic movement in real-time, enables progress tracking and allows active physician involvement, all of which support women’s success. Recognizing that level-one evidence shows pelvic floor muscle training is most effective when performed under the supervision of a skilled healthcare provider, the Leva System is available by prescription only, allowing physicians the opportunity to treat UI and chronic FI on a broad scale and with continued involvement in patient success. The Leva System has multiple clinical trials and published data from globally recognized medical centers supporting its efficacy in treating UI, including two studies in Obstetrics and Gynecology (The Green Journal), the official publication of the American College of Obstetricians and Gynecologists (ACOG).
About Axena Health
Axena Health, Inc. is dedicated to improving the lives of women with pelvic floor disorders. Axena Health’s flagship product, the Leva® Pelvic Health System, offers a novel, effective, first-line treatment for urinary incontinence (UI) and chronic fecal incontinence (FI), underreported conditions affecting over 78 million and 12 million women in the U.S. alone. Axena Health's technology enables non-invasive, drug-free treatment via precise visualization of movement in real time during pelvic floor muscle training, while monitoring usage and progress. For more information, please visit www.axenahealth.com or www.levatherapy.com and follow Axena Health on LinkedIn.
Important Indication and Other Information for the Leva® Pelvic Health System
The Leva® Pelvic Health System is intended for (1) strengthening of pelvic floor muscles, (2) rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed, and mild to moderate urgency urinary incontinence (including overactive bladder) in women and (3) rehabilitation and training of weak pelvic floor muscles for the first-line treatment of chronic fecal incontinence (>3-month uncontrolled passage of feces) in women. Treatment with the Leva System is by prescription and is not for everyone. Please talk to your prescriber to see if Leva System is right for you. Your prescriber should discuss all potential benefits and risks with you. Do not use Leva System while pregnant, or if you think you may be pregnant, unless authorized by your doctor. For a complete summary of the risks and instructions for the Leva System, see its Instructions for Use available at www.levatherapy.com.
