New Real-World Evidence Study Shows Leva® Pelvic Health System Significantly Improves Fecal Incontinence Symptoms in Women

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NEWTON, Mass.--(BUSINESS WIRE)--Mar 9, 2026--

Axena Health, Inc., a women's health company redefining the standard of care for pelvic health through clinically proven, non-invasive treatments, today announced the publication of a new real-world evidence study in Diseases of the Colon & Rectum showing that the Leva Pelvic Health System leads to clinically meaningful improvement in fecal incontinence (FI) symptoms and pelvic floor function in women.

The study, entitled "A Digital Therapeutic Pelvic Health System Improves Fecal Incontinence Symptoms in a Real-World Patient Cohort" examined the use of Leva – a comprehensive, prescription-based digital therapeutic that combines an intravaginal motion-based biofeedback device, a smartphone application, personalized coaching and adherence support, and remote progress tracking – to deliver supervised pelvic floor muscle training (PFMT) at home. The 214 adult women enrolled were divided into two groups based on how FI was identified — by self-report or by clinical diagnosis.

Nearly 60% of participants achieved a minimum clinically important difference (MCID), after just eight weeks of therapy. Seventy-three percent reported that their symptoms had improved overall. Pelvic floor muscle performance — measured directly by the Leva device — improved meaningfully over the course of the study, women remained consistent with their treatment week over week, and no serious safety concerns related to the device were reported.

“For far too long, fecal incontinence has been minimized as something women are expected to endure – underdiagnosed, undertreated, and rarely discussed,” said Dr. Samantha Pulliam, MD, FACOG, Chief Executive Officer of Axena Health. “As a clinician, I see how deeply this condition affects women’s confidence, independence, and daily decision-making. In this real-world study, nearly 60% of women achieved a clinically meaningful improvement in symptoms along with high levels of adherence, indicating they are both motivated and therapy was easy to incorporate into their day-to-day lives. That is exactly why Axena designed Leva as a home-based, first-line treatment – to remove barriers to care and deliver evidence-based pelvic health treatment in a way that is accessible, practical, and built around women.”

Fecal incontinence is one of the most underreported and undertreated conditions in women's health. It affects approximately 12 million women in the United States, yet fewer than 3% ever receive a clinical diagnosis 1 — and many never seek care at all, held back by stigma, limited awareness, or lack of access to specialists. For those who do seek treatment, options have historically been limited: existing interventions, including surgical approaches, have shown inconsistent results and carry significant risk, leaving most women without a truly effective path forward. While pelvic floor muscle training (PFMT) is globally recognized as a key component of first-line treatment, structural barriers and deeply rooted stigma have kept it out of reach for most women. Even when accessed, outcomes are often undermined by low adherence, incorrect technique, and a shortage of specialty-trained clinicians.

“Across every setting I've worked in — from physical therapy offices in the U.S. to low-resource communities globally — the story is the same: when women are given a real, accessible path to treatment for incontinence, they engage and they improve," said Laura Keyser, DPT, MPH, Director of Clinical Strategy and Global Health at Axena Health. "Fecal incontinence quietly erodes daily life — and when left untreated, that erosion compounds into other serious health issues that carry their own lasting consequences. This study reinforces what women have been telling us all along: the barrier has never been willingness — it has been access. By delivering supervised pelvic floor muscle training directly to women at home, Leva helps close that gap and brings effective care to women who have gone without it for far too long.”

This publication joins a robust portfolio of peer-reviewed evidence supporting Leva's effectiveness in treating urinary incontinence, including multiple studies published in Obstetrics & Gynecology (The Green Journal), the International Urogynecology Journal, and JMIR Publications.

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.levacares.com and follow Axena Health on LinkedIn.

About the Leva® Pelvic Health System
The Leva® Pelvic Health System offers an innovative, non-invasive, medication-free way for women to treat urinary incontinence (UI) and chronic fecal incontinence (FI) — at home in just five minutes a day. Combining a small FDA-cleared vaginal motion sensor with integrated software, the Leva System offers precise, real-time visualization of pelvic movement, progress tracking and active physician involvement, all of which support improved treatment outcomes. The Leva System is available by prescription only, enabling physician engagement in each patient’s success while also offering scalable first-line treatment of UI and chronic FI. 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).

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.levacares.com.

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Makenna Lukens,[email protected]

KEYWORD: MASSACHUSETTS UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: TECHNOLOGY MOBILE/WIRELESS HEALTH CONSUMER APPS/APPLICATIONS OTHER HEALTH PUBLISHING TELEMEDICINE/VIRTUAL MEDICINE SOFTWARE MANAGED CARE GENERAL HEALTH COMMUNICATIONS HEALTH TECHNOLOGY WOMEN

SOURCE: Axena Health, Inc.

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PUB: 03/09/2026 09:27 AM/DISC: 03/09/2026 09:27 AM

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