NEWTON, Mass.--(BUSINESS WIRE)--Axena Health, Inc. (Axena Health), a women’s health medical device company focused on scalable treatments for female pelvic health, congratulates the researchers who received “Best Overall Abstract Presentation” from the International Urogynecological Association (IUGA) at its annual meeting in The Hague / The Netherlands on June 21-24, 2023. Lead Author Dr. Milena M. Weinstein of Massachusetts General Hospital, Harvard Medical School, presented the award-winning abstract, which showed that Leva® Pelvic Health System use provides durable and significantly greater improvement in urinary incontinence (UI) symptoms compared to home pelvic floor muscle training (PFMT) alone. Study authors concluded that for women choosing first-line care at home for stress and mixed UI, a motion-based device should be considered to optimize results.
The abstract, “18 and 24-month follow up of a randomized controlled trial comparing 8 weeks of pelvic floor muscle training guided by a digital therapeutic device vs. home program,” compared the long-term efficacy and durability of an 8-week course of PFMT facilitated by the Leva System with a home program of PFMT to treat stress or stress-dominant mixed UI symptoms. Combining a small vaginal motion sensor and integrated software, the Leva System offers an easy, non-invasive, drug-free way for women to perform PFMT, which they can do at home in just five minutes a day. As a prescription medical device, the Leva System enables supervised PFMT, which level one evidence shows is most effective.
“Urinary incontinence is reaching the level of a public health crisis,” said Milena M. Weinstein, MD, FACOG, FACS, Co-Chair, Massachusetts General Hospital, Center for Pelvic Floor Disorders, Program Director, Female Pelvic Medicine and Reconstructive Surgery Fellowship, Associate Professor of Gynecology and Reproductive Biology, Harvard Medical School, and presenter of the “Best Overall” abstract. “Women’s healthcare providers urgently need a way to effectively treat urinary incontinence for the growing number of women living with the financial, emotional and logistical burdens of bladder leaks. Our study amassed two years of data that support the use of the Leva System for durable and significantly greater improvement in urinary incontinence symptoms than a home program of PFMT. We’re honored to receive IUGA’s ‘Best Overall Abstract Presentation’ at this year’s annual meeting and look forward to sharing the two-year longitudinal data from the study.”
The IUGA abstract, summarizing 18- and 24-month symptom improvement data, extends the results of the authors’ two published studies: a pivotal randomized controlled superiority trial (RCT) and one-year longitudinal follow up study, which showed that the Leva System offers effective, durable treatment for UI in women. The IUGA abstract affirms that UI symptom improvement from just eight weeks of treatment with the Leva System lasts at least 24-months. The ongoing study is one of very few that tracks long-term symptom improvement for a non-surgical intervention for UI. Study authors include Dr. Weinstein, Dr. Gena Dunivan of the University of Alabama, Dr. Noelani Guaderrama with Kaiser Southern California, and Dr. Holly E. Richter of the University of Alabama.
“More than 60 percent of adult women in the United States experience urinary incontinence,” said Samantha Pulliam, M.D., Axena Health’s Chief Medical Officer. “We are grateful to the study authors’ clear commitment to affecting these unsettling prevalence data, which dramatically increased in 2022 following revised estimates. We congratulate them on the IUGA’s prestigious recognition of their work and look forward to the impact this data can have on women who experience urinary incontinence.”
The U.S. Food and Drug Administration (FDA) cleared the Leva System in 2019 for the treatment of stress, mixed and mild-to-moderate urgency urinary incontinence (UI). On June 20, 2023, during World Continence Week, Axena Health introduced the Leva System for the treatment of chronic fecal incontinence (FI) in women following FDA clearance for the new indication in 2022 and Breakthrough Device Designation in 2021. The new product introduction supports a single treatment option for the 20 percent of women with UI who also suffer from FI.
UI is a progressive disease that, left untreated, can severely impact women’s quality of life and impose enormous physical, psychological and economic burdens. PFMT, commonly practiced via Kegels, is first-line treatment, but data show achieving effective, consistent practice is challenging for most women. The Leva System makes PFMT accessible by guiding women through their practice. In May 2023, Axena Health announced a large-scale study into the burdens of incontinence on women in low- and middle-income countries. The findings will guide the development of new treatment options based on the Leva System that are culturally acceptable and available within local healthcare pathways.
About the Leva® Pelvic Health System
The Leva® Pelvic Health System is a prescription medical device available in the United States that 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 and integrated software, the Leva System offers precise visualization of pelvic movement in real-time, enables progress tracking and allows active clinician 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 is the first femtech product included in the Digital Therapeutics Alliance product library and 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 a women-led company 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, follow Axena Health on LinkedIn and follow Leva Pelvic Health System on Instagram and TikTok.
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.
