Home Biofeedback Device Shows Major Gains for Fecal Incontinence

NEWTON, MA – April 16, 2026 – A groundbreaking study published in Urogynecology, the official journal of the American Urogynecologic Society (AUGS), has provided robust clinical validation for a home-based digital therapeutic system in treating fecal incontinence (FI), a condition that affects an estimated 12 million women in the U.S. but remains profoundly undertreated. The randomized controlled trial demonstrated that the Leva® Pelvic Health System from Axena Health provides statistically and clinically significant symptom improvement in as little as eight weeks, offering a new standard of care for a condition long shrouded in silence and stigma.

The trial, conducted at the University of Wisconsin–Madison, is a significant milestone for both the company and the field of digital therapeutics, lending the weight of rigorous scientific evidence to a discreet, technology-driven solution for a deeply personal health issue.

Breaking the Silence on a Common Condition

Fecal incontinence, the uncontrolled passage of feces, is a debilitating condition that severely impacts quality of life. Despite its prevalence, research indicates that fewer than 3% of affected women receive a clinical diagnosis. The associated stigma often prevents individuals from discussing symptoms even with their doctors, leading them to suffer in silence and withdraw from social activities. This lack of reporting has historically limited the development and adoption of effective, accessible treatments.

Axena Health’s Leva system directly confronts these barriers. The recent study highlights how a home-based, user-friendly device can drive patient engagement where traditional methods may fail. Participants in the trial demonstrated a high mean treatment adherence of 75%, a critical factor in the success of any physical therapy regimen. The Leva app was also consistently rated as "easy to use," underscoring the importance of design in patient-centric care.

"Fecal incontinence affects millions of women, yet it remains severely undertreated due to stigma and limited access to specialized care," said Dr. Samantha Pulliam, CEO & Chief Medical Officer of Axena Health, in the company's announcement. "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 Weight of Clinical Evidence

The new publication is significant not just for its positive results, but for the rigorous methodology behind them. As a single-blind randomized controlled trial, it represents a high standard of clinical evidence. The study was designed to determine if an 8-week treatment course with Leva could produce results equivalent to a longer 16-week course. The findings confirmed this equivalence, showing that a shorter duration can yield powerful, lasting results.

Over half of the participants in both the 8-week and 16-week groups reported at least a 50% improvement in their symptoms. Crucially, the overall estimated percent improvement of 63% was sustained at a 24-week follow-up, suggesting the benefits are not fleeting. This evidence for durability is key for a chronic condition.

This study adds to a growing portfolio of peer-reviewed evidence supporting Leva's efficacy for both fecal and urinary incontinence. The system, which is available by prescription only, received FDA clearance for the first-line treatment of chronic FI in July 2022, following a Breakthrough Device Designation in 2021. This regulatory pathway is reserved for medical devices that provide for more effective treatment of life-threatening or irreversibly debilitating conditions.

Beyond Kegels: How Biofeedback Elevates Pelvic Training

Clinical guidelines have long recommended supervised pelvic floor muscle training (PFMT), often known as Kegels, as a first-line treatment for pelvic floor disorders. However, many women perform the exercises incorrectly or inconsistently without proper guidance, limiting their effectiveness.

The Leva Pelvic Health System is designed to solve this problem by integrating technology directly into the training process. It combines a small vaginal motion sensor with a smartphone app to provide precise, real-time visualization of pelvic floor muscle movement. This biofeedback mechanism allows users to see if they are performing the exercises correctly, track their progress, and stay motivated through guided sessions that take just five minutes a day.

"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,” noted Laura Keyser, DPT, MPH, Director of Clinical Strategy and Global Health at Axena Health. This approach effectively moves supervised physical therapy from the clinic into the user's home, removing barriers of time, travel, and cost associated with frequent specialist visits.

Navigating the Path to Patient Access

With strong clinical evidence and FDA clearance, the final hurdle for any medical innovation is accessibility. As a prescription device, Leva ensures that a healthcare provider is involved in a patient's diagnosis and treatment plan. While the retail price for such technology can be a barrier, Axena Health has worked to establish pathways for reimbursement.

The system is covered by many national and regional insurance providers and is eligible for payment through Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA). The company also offers payment plans and benefit verification services to help patients navigate their coverage options.

Significantly, Axena Health has secured partnerships to make the Leva system available to female veterans through the Veterans Health Administration (VHA), the VA Community Care Network (CCN), and the Military Health System (MHS). This move not only expands access to a large and deserving population but also serves as a powerful endorsement from a major federal healthcare provider, signaling growing confidence in the technology's role in modern healthcare.