Leva Pelvic Health System: New Study Shows Relief for Fecal Incontinence in Women

For women experiencing the often-silent struggle with fecal incontinence, a new study offers a promising, non-invasive path toward relief. Published in Diseases of the Colon & Rectum, research indicates the Leva® Pelvic Health System significantly improves symptoms and pelvic floor function. The findings, released today by Axena Health, Inc., suggest a potential advancement in treating a condition frequently underdiagnosed and undertreated.

Understanding Fecal Incontinence and the Leva System

Fecal incontinence, the involuntary leakage of stool, affects millions of women. It can range from occasional accidents to a complete loss of bowel control, significantly impacting quality of life. Often, individuals delay seeking facilitate due to embarrassment or the misconception that it’s an inevitable part of aging. The Leva system aims to address this by offering a prescription-based digital therapeutic. This isn’t a medication; instead, it’s a comprehensive program combining an intravaginal biofeedback device, a smartphone application, personalized coaching and remote monitoring to deliver supervised pelvic floor muscle training (PFMT) at home. Leva is similarly approved for treating urinary incontinence.

Study Details and Key Findings

The study enrolled 214 adult women, categorizing them based on whether their fecal incontinence was identified through self-report or clinical diagnosis. Participants used the Leva system for eight weeks. The results showed that nearly 60% achieved a minimum clinically important difference (MCID) in their symptoms. Even more encouraging, 73% of participants reported overall symptom improvement. Importantly, the device itself directly measured improvements in pelvic floor muscle performance throughout the study. Researchers also noted consistent adherence to the treatment plan and reported no serious safety concerns related to the device.

“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, in a statement accompanying the study’s release. This sentiment underscores the need for increased awareness and accessible treatment options.

How Does Pelvic Floor Muscle Training Help?

Pelvic floor muscles play a crucial role in bowel control. Weakened or damaged muscles can contribute to fecal incontinence. PFMT, often referred to as Kegel exercises, aims to strengthen these muscles. Though, performing these exercises correctly can be challenging. The Leva system’s biofeedback device provides real-time guidance, helping women ensure they are engaging the correct muscles effectively. This supervised approach, delivered remotely, overcomes some of the barriers to traditional pelvic floor therapy, such as access to specialized clinics and the need for in-person appointments.

What the Study Doesn’t Tell Us

While the study results are promising, it’s important to acknowledge its limitations. The research was conducted on a specific cohort of women, and the findings may not be generalizable to all populations. The study also relied on both self-reported symptoms and clinical diagnoses, which can introduce subjectivity. The eight-week timeframe provides insight into short-term improvements, but long-term efficacy remains to be seen. Additional research is needed to determine the durability of these benefits and to identify which women are most likely to respond to the Leva system. The study, as published in Business Wire, does not address potential cost-effectiveness or comparative effectiveness against other treatment modalities.

Beyond the Device: A Holistic Approach

It’s crucial to remember that fecal incontinence can have multiple contributing factors, including diet, medication, underlying medical conditions, and nerve damage. The Leva system is best viewed as one component of a comprehensive treatment plan. Individuals experiencing fecal incontinence should consult with a healthcare professional to determine the underlying cause and develop a personalized management strategy. This may involve dietary modifications, medication adjustments, or other therapies in addition to PFMT. The Leva website provides resources for both women and healthcare providers interested in learning more about the system and accessing a prescription.

What’s Next for Leva and Fecal Incontinence Treatment?

Axena Health is continuing to gather real-world evidence on the Leva system’s effectiveness. Further studies are planned to investigate its long-term benefits and to explore its potential in different patient populations. The company is also working to expand access to the system through partnerships with healthcare providers and insurance companies. The broader field of pelvic health is also seeing increased attention, with growing recognition of the importance of addressing conditions like fecal and urinary incontinence. This increased awareness is likely to drive further innovation and improve the quality of care for women experiencing these often-debilitating conditions.