Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, announced today that the National Institutes of Health’s (NIH) Pelvic Floor Disorders Network (PFDN) will include the Leva® Pelvic Health System in a multi-center clinical study designed to compare treatment methods for first-time mothers experiencing urinary incontinence (UI). The study will enroll 216 women who will access one of three treatments for UI: “usual care” (i.e., patient education about Kegel exercises and other lifestyle changes at home), interventionist-guided pelvic floor muscle training (PFMT), and Leva-guided PFMT. Study results will provide valuable guidance to clinicians and women who want to access PFMT using a method that best supports their success.
The “Training for Urinary Leakage Improvement after Pregnancy” (TULIP) study (NCT06411158; https://bit.ly/TULIP-study) will enroll postpartum women who had elevated risk factors for UI during delivery of their baby and are now experiencing bothersome UI symptoms. Axena will provide 72 Leva® devices, technical support, and coaching sessions with new mothers receiving the devices.
The PFDN is funded by the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and consists of a data coordinating center at RTI International and six leading clinical research sites:
Duke University – Durham, North Carolina
University of California at San Diego and Kaiser Permanente – San Diego, California
University of Chicago – Chicago, Illinois
University of Texas Southwestern Medical Center – Dallas, Texas
University of Pennsylvania – Philadelphia, Pennsylvania
Women and Infants Hospital (Brown University) – Providence, Rhode Island
“Pelvic floor muscle training is a globally recommended first-line treatment for urinary incontinence,” said Samantha Pulliam, MD, Chief Medical Officer for Axena Health. “TULIP is designed to understand the value of PFMT to treat UI in postpartum women and provide clinicians valuable guidance about the available therapy options for these women who experience troubling UI after having a baby. First-line treatment works, and data that guides clinicians and women toward an effective modality will help more women recover effectively after childbirth and enjoy life without the significant social, financial, emotional and physical burdens of incontinence.”
Pelvic floor disorders (PFDs) affect one-third of women globally: UI is the most common, affecting 62 percent of adult women in the U.S. PFMT is effective first-line treatment, but lack of awareness contributes to low care-seeking behaviors, placing women at risk for psychosocial, economic, and physical burdens. Left untreated, UI symptoms often worsen. It is the #2 reason older women enter a nursing home. The PFDN was created by the Eunice Kennedy Shriver National Institute of Child Health and Human Development to study pelvic floor disorders and provide evidence-based answers for women and health care providers about treatment options. It has published 160 papers and presented 166 abstracts since its inception in 2001.
About the Leva®Pelvic Health System
The Leva® Pelvic Health System offers an innovative, non-invasive, medication-free way for women to train and strengthen their pelvic floor muscles—at home in just five minutes a day—to treat urinary incontinence (UI) and chronic fecal incontinence (FI). Combining a small FDA-cleared vaginal motion sensor with integrated software, the Leva System offers precise visualization of pelvic movement in real-time, enables progress tracking and allows active physician involvement, all of which support women’s success. Recognizing that level one evidence shows pelvic floor muscle training is most effective when performed under the supervision of a skilled healthcare provider, the Leva System is available by prescription only, allowing physicians the opportunity to treat UI and chronic FI on a broad scale and with continued involvement in patient success. 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).
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.levatherapy.com and follow Axena Health on LinkedIn.
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.levatherapy.com.
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