di , 01/03/2023

Study shows long-term effectiveness and durability of at-home, digital health treatment for urinary incontinence in women

NEWTON, Mass.–(BUSINESS WIRE)–#DigitalHealth–Axena Health, Inc. (Axena Health), a medical device company relentlessly dedicated to women’s health, today announced the results of a one-year longitudinal follow up to its pivotal randomized controlled superiority trial (RCT) of the Leva® Pelvic Health System as a treatment for urinary incontinence (UI) in women. The results, published in Obstetrics and Gynecology (The Green Journal), the official publication of the American College of Obstetricians and Gynecologists (ACOG), showed that Leva-guided pelvic floor muscle training (PFMT) yielded significantly greater symptom improvement compared with PFMT practiced by Kegel exercises. The study measured outcomes at six and 12 months, making it one of the few studies to track long-term symptom improvement for a non-surgical intervention for UI.

The Leva Pelvic Health System (the Leva System) is a prescription digital therapeutic (PDT) that offers easy-to-use, at-home treatment for urinary and chronic fecal incontinence (FI) in women. In the new study, “Digital Therapeutic Device for Urinary Incontinence: A Longitudinal Analysis at 6 and 12 Months,” researchers from leading medical centers evaluated the long-term efficacy of an eight-week regimen of PFMT guided by the Leva System compared with a home program of Kegels for the treatment of stress urinary incontinence (SUI) and stress-predominant mixed urinary incontinence (MUI). Of the 299 participants, women using the Leva System experienced durable, significantly greater improvement in UI symptoms compared with women who relied on Kegels alone. At one-year post-treatment, women in the Leva arm of the study had more than twice the odds of reporting improvement compared to those who did Kegels alone.

“Urinary incontinence affects more than half of adult women in the United States with more than 28 million reporting moderate or severe symptoms,” said Milena M. Weinstein, M.D., a principal investigator, Female Pelvic Medicine and Reconstructive Surgery Fellowship program director, Co-Chair, Center for Pelvic Floor Disorders at Massachusetts General Hospital, and Associate Professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School. “First-line treatment is effective, but most women lack access to skilled care and inconsistent or incorrect performance can limit PFMT’s benefits. Our first study showed the Leva System is statistically and clinically superior to Kegels alone for improving UI symptoms. This planned follow up study affirmed these findings and showed that symptom relief is durable. Combined, these data suggest that the Leva System can be an effective modality for scaling access and adherence to first-line care among a large population of women affected by UI.”

The recent study, which published in January 2023, is the planned follow up analysis of a prior study, “Digital Therapeutic Device for Urinary Incontinence: A Randomized Controlled Trial,” which the Green Journal published in April 2022. The 2022 RCT publication demonstrated the Leva System’s superiority over Kegels alone to treat UI, concluding that the Leva System “significantly improved” symptoms of UI in women versus Kegel exercises alone. The 2023 publication announced today shows that UI symptom improvement lasts, even without ongoing use of the Leva System.

“This pivotal study shows that women using the Leva System achieved not only significantly greater improvement in urinary incontinence symptoms than the group that relied on Kegels alone, but that this improvement lasted a full year even without continued use beyond the eight-week exercise period,” said Samantha Pulliam, M.D., Axena Health’s Chief Medical Officer. “There are few studies in the literature that document long-term follow up such as this for non-surgical urinary incontinence interventions, making this study even more important as we learn how to help women obtain symptom relief from what is typically a long-term condition.”

62% of U.S. adult women live with UI, a progressive disease that, left untreated, can have a severe impact on a woman’s quality of life, imposing enormous physical, psychological and economic burdens. PFMT, commonly practiced via Kegels, is first-line treatment, but achieving effective consistent practice can be challenging. The Leva System makes first-line treatment accessible by guiding women through PFMT, offering an easy, non-invasive, drug-free way for them to improve UI and chronic FI symptoms. Treatment with the Leva System requires just five minutes per day, which women can do at home, on their own schedule. It’s cleared by the U.S. Food and Drug Administration (FDA) to treat stress, mixed and mild-to-moderate urgency UI (including overactive bladder) in women and for first-line treatment of chronic FI in women for which it received Breakthrough Designation. Last month, Axena Health received a $25 million Series A investment from AXA IM Alts through its Global Healthcare Private Equity Strategy to support and expand access to the Leva System.

“Urinary incontinence is common, but it should not be normal,” said Eileen Maus, CEO of Axena Health. “The Leva System is backed by some of the most rigorous data in medicine, and these data continue to accumulate and unanimously show that the Leva System not only treats UI effectively, but also gives clinicians a valuable way to help more women access easy, effective first-line treatment. The opportunity to take agency of one’s own pelvic floor—without drugs or surgery—is the quality of care we feel women deserve, and we’re dedicated to making that care available to the largest group of women possible. We’re very grateful to the investigators and clinicians who share this commitment.”

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 connected to a smartphone app, 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 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.levatherapy.com and follow Axena 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.


Media: Shanti Skiffington 617-921-0808