Study: Leva Pelvic Health System Improves Fecal Incontinence Symptoms in Women

Axena Health Inc. is sharing new study results indicating the Leva Pelvic Health System leads to clinically meaningful improvement in fecal incontinence (FI) symptoms and pelvic floor function in women.

The study in Diseases of the Colon & Rectum, “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 the way FI was identified, either by self-report or 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,” Axena Health CEO Samantha Pulliam, M.D., said. “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 U.S. women, yet fewer than 3% receive a clinical diagnosis and many never seek care at all, as they are discouraged by stigma, limited awareness, or lack of access to specialists. For those who seek treatment, options have historically been limited: Existing interventions, including surgical approaches, have shown inconsistent results and carry significant risk, leaving most women without an 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,” Axena Health Clinical Strategy and Global Health Director Laura Keyser stated. “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.”

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

The Leva Pelvic Health System offers a non-invasive medication-free way for women to treat urinary incontinence (UI) and chronic fecal incontinence at home in just five minutes a day. Combining a small U.S. Food and Drug Administration-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, helping physicians engage in each patient’s success and offering scalable first-line UI and chronic FI treatment.

Axena Health, Inc. aims to improve the lives of women with pelvic floor disorders. The company’s technology offers a modern approach to supervised pelvic floor muscle training through precise visualization of real-time movement, while monitoring usage and progress.