NEWTON, Mass. — Axena Health Inc., a women’s health technology company focused on noninvasive pelvic health treatments, announced the publication of a real-world evidence study showing that its Leva Pelvic Health System significantly improved fecal incontinence symptoms and pelvic floor function in women.
The study, published in the peer-reviewed journal Diseases of the Colon & Rectum, evaluated the use of the prescription-based digital therapeutic in a real-world patient population. Researchers reported clinically meaningful symptom improvement, strong user engagement and measurable gains in pelvic floor muscle performance among participants.
The research, titled “A Digital Therapeutic Pelvic Health System Improves Fecal Incontinence Symptoms in a Real-World Patient Cohort,” followed 214 adult women using the Leva system, which combines an intravaginal motion-based biofeedback device, smartphone application, personalized coaching and remote progress tracking to support pelvic floor muscle training at home.
Participants were divided into groups based on whether fecal incontinence was identified through self-reporting or clinical diagnosis.
After eight weeks of therapy, nearly 60 percent of participants achieved a minimum clinically important difference in symptoms. Overall, 73 percent of participants reported improvement in their condition. Researchers also observed measurable improvement in pelvic floor muscle performance through data captured by the Leva device. Women remained consistent in completing therapy sessions, and no serious safety concerns related to the device were reported.
“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,” 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. 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 affects an estimated 12 million women in the United States but remains widely underreported and undertreated. Researchers say fewer than 3 percent of women with the condition receive a formal clinical diagnosis, often due to stigma, lack of awareness or limited access to specialists.
Pelvic floor muscle training is widely recognized as a first-line therapy for fecal incontinence, but access to trained clinicians and adherence challenges have historically limited its effectiveness in real-world settings.
“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. “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.”
