Prestigious journal shows leva Pelvic Health System significantly improves urinary incontinence symptoms in women

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Mar 14, 2022, 09:28 ET

New study shows leva is better than Kegels alone to improve stress and mixed UI symptoms

CHARLESTON, S.C., March 14, 2022 /PRNewswire/ -- The National Association for Continence (NAFC), the nation's leading advocate for people living with bladder and bowel disorders, highlighted a new study today that offers hope for the 78 million women who experience urinary incontinence (UI). On March 10, the official journal of the American College of Obstetricians and Gynecologists (ACOG), Obstetrics & Gynecology ("the green journal") published a rigorous study showing that women with UI who performed pelvic floor muscle training (PFMT) using leva achieved significant improvement in their UI symptoms and fewer leaks compared with women who followed a program of Kegel exercises alone.

"The green journal is among the most prestigious journals in women's health," said Steven G. Gregg, PhD, Executive Director of NAFC. "Women have been looking for a good, effective treatment for stress urinary incontinence for years. Unfortunately, there has been little available that has been effective, reasonably easy to use, and most importantly, accessible. Physicians have had little to offer those looking for a significant improvement in bladder leakage. We are pleased that Renovia has undertaken a large randomized clinical trial to demonstrate the efficacy of a new treatment option. Hopefully, those looking for the level of care they deserve will be able to find it."

PFMT is first-line treatment for UI. Studies show it can resolve or reduce UI symptoms, improve immediate and long-term condition-specific quality of life, and limit the need for costly or more invasive treatments. However, many women find Kegels difficult to practice correctly and consistently on their own, limiting their success. The leva^® Pelvic Health System combines novel motion sensor technology with a smartphone app and personal coaching, which helps women perform PFMT successfully. The system is Food and Drug Administration-cleared for the treatment of stress, mixed and mild to moderate urgency UI. It requires just five minutes of practice a day, which women can do at home, on their own schedule. The study affirms leva's efficacy and offers women a new opportunity to make first-line treatment for UI successful.

"This remote RCT is a first for women's health," said Milena Weinstein, MD, one of the lead investigators for the study. "A prescription digital therapeutic not only helps make drug- and surgery-free treatment for UI successful, it also gives clinicians an easy, effective way to help more women, regardless of location, time constraints or their ability to access care. It's never too late for women to strengthen their pelvic floor. As UI prevalence continues to rise, and in my opinion, resembles a public health crisis, the data supporting a digital therapeutic for UI has never been more critical or welcome."

The study, "Digital Therapeutic Device for Urinary Incontinence: A Randomized Controlled Trial," is available online on an open access basis through Obstetrics & Gynecology, and will appear in the April print edition. Please visit www.levatherapy.com to learn more about leva.

Important Indication and Other Information for the leva Pelvic Health System
The leva Pelvic Health System, developed by Renovia Inc., is intended for strengthening of pelvic floor muscles, and 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. Treatment with the leva System is by prescription and is not for everyone. Please talk to your prescriber to see if leva is right for you. Your prescriber should discuss all potential benefits and risks with you. Do not use leva 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.renoviainc.com and www.levatherapy.com.

About NAFC
National Association for Continence is a national, private, non-profit 501(c)(3) organization dedicated to improving the quality of life of people with incontinence, voiding dysfunction and related pelvic floor disorders. NAFC's is the leading source for education and advocacy about the causes, prevention, diagnosis, treatments and management alternatives for incontinence. More information is available at www.NAFC.org.

Media inquiries: Shanti Skiffington, mobile: 617 921-0808

SOURCE Renovia Inc.