NEWTON, Mass.–(BUSINESS WIRE)–Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, has launched a study to examine the barriers women faced while seeking treatment for urinary incontinence (UI) and fecal incontinence (FI). The study is expected to include 500 real-world users of the Leva® Pelvic Health System and follows a pilot survey showing that most participants were unsuccessful trying pelvic floor muscle training (PFMT) on their own or with a physical therapist. Study results could help clinicians, payers and policy makers accelerate access to easy, effective first-line treatment for UI and FI.

“I now know that I wasn’t doing Kegel exercises properly, and that I can now. The Leva System kept me on track and provided me with a safe, private, and convenient way to improve my pelvic floor in the comfort of my own home.”

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“Professional societies and medical guidelines recommend conservative, first-line treatment for urinary and fecal incontinence,” said Eileen Maus, Axena Health’s CEO. “A growing body of published data shows that UI and FI often go untreated. When they are treated, patients often skip to advanced therapies such as medications and surgery. My hope is that our study will help us better understand the patient journey and the barriers to first-line, conservative care.”

62% of U.S. adult women live with UI. It’s a progressive condition that left untreated, can severely impact a woman’s quality of life and impose enormous physical, psychological, and economic burdens. A January 2024 study in Menopause showed that UI has a strong association with multiple domains of disability, including mobility and interacting with others. Data shows early intervention—specifically, PFMT—can help resolve or reduce UI symptoms, improve near-term and long-term condition-specific quality of life, and limit the need for costly or more invasive treatments.

The study will reveal important information about women’s experience seeking care for UI. Participants can share their experiences using the Leva System throughout the study. Jody, age 65, a current study participant shared, “I now know that I wasn’t doing Kegel exercises properly, and that I can now. The Leva System kept me on track and provided me with a safe, private, and convenient way to improve my pelvic floor in the comfort of my own home.”

“While Kegels are accessible, they don’t work for most women,” said Annette Brewster, Axena Health’s Vice President, Patient Services and Commercial Operations. “Physical therapy can help, but it’s not widely accessible. The Leva System offers an at-home alternative so women can access effective PFMT privately, on their own schedule. We’re working hard to ensure that all women have access to the Leva System and hope this study will help us continue to convince payers and providers to support women’s access to effective, convenient first-line treatment.”

Axena Health’s study is currently enrolling participants. Women who wish to join the study should speak with their clinician or visit www.levatherapy.com.

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). The Leva System was recently named to AARP’s 2023 Medical Breakthroughs. Combining a small FDA-cleared vaginal motion sensor device 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 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). In May 2023, Axena Health announced a global study to examine the burdens of incontinence for 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 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 the 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.