Innovative Leva System in Trials to Treat Postpartum UI
Revolutionizing Treatment for Postpartum Urinary Incontinence
Axena Health, Inc. is the forefront company aiming to enhance women's pelvic health through their innovative solutions. They have recently announced a significant collaboration with the National Institutes of Health's Pelvic Floor Disorders Network to incorporate the Leva Pelvic Health System into an extensive clinical study. This study is particularly focused on first-time mothers grappling with urinary incontinence (UI), a common issue that affects many women after childbirth.
Understanding the Clinical Study's Objectives
The clinical trial, known as “Training for Urinary Leakage Improvement after Pregnancy” (TULIP), plays a vital role in comparing various treatment methodologies for postpartum UI. Specifically, the study aims to evaluate the effectiveness of three treatment options: usual care that consists of education around Kegel exercises and lifestyle modifications, interventionist-guided pelvic floor muscle training (PFMT), and Leva-guided PFMT. With 216 women participants enrolled, the findings are expected to guide healthcare professionals and patients in choosing the most suitable PFMT approach for optimal recovery.
Technology and Support Provided
Axena Health's involvement in this study includes supplying 72 Leva devices, which are designed to assist in the rehabilitation of pelvic floor muscles. Participants will receive technical support and coaching sessions, which significantly enhance their engagement and understanding of using the Leva System effectively. The combination of technology and support is expected to improve treatment outcomes for women experiencing UI.
Significance of the Pelvic Floor Disorders Network
The Pelvic Floor Disorders Network is crucial in addressing how pelvic floor disorders impact women globally. Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the network comprises six leading clinical research sites. Its objective is to find evidence-based answers to treatment options available for PFDs, of which UI is one of the most prevalent forms.
Clinical Importance of Pelvic Floor Muscle Training
As one of the most recommended first-line treatments for urinary incontinence, pelvic floor muscle training is gaining recognition within the medical community. According to Dr. Samantha Pulliam, Chief Medical Officer at Axena, the TULIP study will provide invaluable insights into how PFMT can alleviate the troubling symptoms experienced by postpartum women. Addressing UI effectively not only helps improve women's physical health but also alleviates the emotional and social stress linked to such conditions.
A Closer Look at Research Outcomes
Statistics show that pelvic floor disorders affect around a third of women worldwide, with UI being particularly common, influencing approximately 62% of adult women in the U.S. Currently, not enough women are aware of treatment options, leading to significant psychosocial and physical burdens. The PFDN has made substantial strides since it was established in 2001, producing a wealth of research outputs, including 160 papers and 166 abstracts. This research aims to empower women with knowledge about managing PFDs and encourage them to seek the necessary treatments.
About the Leva Pelvic Health System
The Leva Pelvic Health System is a groundbreaking solution developed by Axena Health, specifically designed for treating urinary incontinence and chronic fecal incontinence. This system encourages women to perform pelvic floor exercises conveniently at home, offering a non-invasive and medication-free alternative. It combines a small FDA-cleared vaginal motion sensor with a user-friendly interface, enabling women to visualize their pelvic movements while tracking their progress over time.
The Unique Value Proposition
Trading traditional methods for contemporary, tech-driven solutions, the Leva System empowers women by involving healthcare providers in their recovery journey. The effectiveness of this innovative system is underscored by evidence drawn from numerous clinical trials conducted at reputable medical centers.
About Axena Health
Dedicated to transforming the lives of women with pelvic floor disorders, Axena Health is committed to providing effective, non-invasive treatments. Their flagship product, the Leva System, serves as a first-line treatment for UI and chronic fecal incontinence, conditions affecting millions of women throughout the U.S. By harnessing advanced technology, Axena Health not only improves treatment effectiveness but also creates a supportive environment for women seeking relief from these often-overlooked conditions.
Frequently Asked Questions
What is urinary incontinence, and who does it affect?
Urinary incontinence is the involuntary leakage of urine, which affects a significant number of women, especially postpartum. It affects about 62% of adult women in the U.S.
What is the goal of the TULIP study?
The TULIP study aims to compare different treatment methods for postpartum urinary incontinence to help identify the most effective approaches for women.
How does the Leva Pelvic Health System work?
The Leva System uses a vaginal motion sensor and integrated software to guide women in performing pelvic floor muscle training from the comfort of their homes.
Why is pelvic floor muscle training important?
Pelvic floor muscle training is a globally recommended treatment for urinary incontinence, promoting recovery and improving overall pelvic health.
Where can I find more information about Axena Health and the Leva System?
More information about Axena Health and the Leva Pelvic Health System is available on their official websites.
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