Randomized Controlled Trial Published in Urogynecology Demonstrates Leva® Pelvic Health System’s Efficacy in Treating Fecal Incontinence

Axena Health, Inc., a women’s health company redefining the standard of care for pelvic health conditions through clinically proven, non-invasive treatments, today announced a new publication entitled “Home-Based Biofeedback for Fecal Incontinence: A Randomized Clinical Trial” in Urogynecology, the official journal of the American Urogynecologic Society (AUGS), demonstrating the effectiveness of the Leva Pelvic Health System in treating fecal incontinence (FI) in women.

The single-blind randomized controlled trial, conducted at the University of Wisconsin–Madison and titled “Home-based biofeedback for fecal incontinence: A randomized clinical trial,” was designed to determine whether 8 weeks of treatment with the Leva Pelvic Health System produced FI symptom improvements equivalent to those observed after 16 weeks of treatment. The study demonstrated equivalence between both treatment durations, with statistically and clinically significant improvements sustained at 24-week follow-up. Over half of participants in each treatment arm reported at least 50% improvement in symptoms and the overall estimated percent improvement was sustained at 63% at 24 weeks.

Fecal incontinence affects approximately 12 million women in the United States, yet fewer than 3% receive a clinical diagnosis.¹ Despite clinical guidelines recommending supervised pelvic floor muscle training (PFMT) as a key component of first-line treatment, the condition remains grossly undertreated and underreported as stigma prevents many women from seeking care and drives demand for discreet, accessible treatment options.

“This randomized controlled trial provides robust evidence that women can achieve meaningful, lasting improvement in fecal incontinence symptoms in as little as 8 weeks with Leva,” said Dr. Samantha Pulliam, MD, FACOG, CEO & Chief Medical Officer of Axena Health. “Fecal incontinence affects millions of women, yet it remains severely undertreated due to stigma and limited access to specialized care. These findings validate that Leva’s supervised pelvic floor muscle training with real-time biofeedback and personalized coaching delivers clinically significant outcomes in a timeframe that supports patient adherence and engagement.”

The study enrolled 38 women who were randomly assigned to either 8 weeks or 16 weeks of treatment with Leva. Both groups demonstrated significant improvements in FI symptoms, global pelvic floor symptoms (PFDI-20), FI quality of life (FIQoL), and patient-reported global impression of improvement. The results demonstrated high patient engagement and satisfaction. Participants achieved a mean treatment adherence of 75%, and the Leva app was consistently rated as “easy to use” – underscoring that accessible, user-friendly treatment options can drive meaningful engagement and outcomes. Additionally, a majority of women reported being “satisfied” or “completely satisfied” with their treatment experience, and their perception of improvement remained high throughout the study period.

“The high adherence rate and ease-of-use ratings show that when treatment is convenient, straightforward, and fits seamlessly into daily life, women engage with it,” said Laura Keyser, DPT, MPH, Director of Clinical Strategy and Global Health at Axena Health. “Leva removes barriers and provides evidence-based pelvic floor muscle training that’s both clinically effective and practical for real-world use.”

This publication joins a robust portfolio of peer-reviewed evidence supporting Leva’s treatment of urinary incontinence (UI) and fecal incontinence (FI) — including multiple studies published in Obstetrics & Gynecology (The Green Journal), the International Urogynecology Journal, and JMIR Publications — and comes on the heels of a peer-reviewed real-world evidence (RWE) study published in Diseases of the Colon & Rectum in March 2026, in which nearly 60% of women using Leva in real-world settings achieved clinically meaningful FI symptom improvement. Together, this growing body of evidence reinforces Leva’s clinical effectiveness in treating both UI and FI — across controlled research settings and the realities of women’s daily lives.

The study was led by Ushma J. Patel, MD; Laura Keyser, DPT, MPH; Natalia Gontarczyk Uczkowski, MPH; Dobie L. Giles, MD, MS, MBA; and Heidi W. Brown, MD, MAS.

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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