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Devices Urology

 News Release - July 22, 2022

Published Studies Find Low Documented Adherence to Guideline-Based Care for Female Urinary Incontinence

Low adherence associated with higher costs for payers

BOSTON, July 22, 2022 -- (Healthcare Sales & Marketing Network) -- Renovia Inc. (Renovia), a developer of non-surgical treatments for female pelvic floor disorders and an advocate for women's health, announced today that Neurourology and Urodynamics published two studies demonstrating low rates of documented adherence to treatment guidelines for female urinary incontinence (UI) care for women and the effect on payer costs. One study showed significantly higher costs for payers in the two years following diagnosis for women whose treatment claims did not align with published guidelines for female UI. A second study showed very low use of physical therapy (PT) for UI, a discipline commonly engaged in first-line care for UI.

Multiple professional societies and evidence-based guidelines recommend Pelvic Floor Muscle Training (PFMT) as a first-line treatment for female UI, a highly prevalent health condition affecting more than 60% of adult women in the U.S. UI is characterized by involuntary leakage of urine and classified into several subtypes. Stress UI (SUI) involves leakage with a physical stress such as sneezing, coughing, or physical exertion. Urgency UI (UUI) refers to the involuntary loss of urine associated with a sudden, compelling desire to pass urine which is difficult to defer. Mixed UI (MUI) is the complaint of symptoms of both SUI and UUI. Numerous studies show PFMT is an effective treatment for urinary incontinence and that PFMT, commonly referred to as Kegels, is challenging for women to implement effectively on their own.

In the study, "Adherence to Professional Society Guidelines Among Women with Stress or Mixed Urinary Incontinence," researchers found that most women with SUI and MUI did not receive documented PFMT and other behavioral interventions that are part of guideline-based first-line care for UI. In fact, less than eight percent of patients with SUI and MUI received a first-line behavioral treatment. The study determined that documented care not sequenced in adherence to guidelines increased payers' cost burden. Women who did not receive an initial intervention and appropriate care accrued significantly higher costs for healthcare payers over a two-year period following their UI diagnosis.

A second study, "Retrospective Claims Analysis of Physical Therapy Utilization among Women with Stress or Mixed Urinary Incontinence," showed that less than three percent of women diagnosed with SUI or MUI visited a physical therapist to treat their UI. Of that number, just 30 percent completed three or more PT visits, suggesting low use of PT for both initiation and completion of first-line UI care. UI clinical guidelines indicate first-line care should be nearly universal for all UI subtypes.

"The vast number of women who experience UI and the known effects on physical and mental health and quality of life mark this as a public health problem," Laura Keyser, PT, DPT, MPH, Senior Manager, Medical Affairs at Renovia and a study co-author. "Screening and treatment guidelines exist, yet clearly, these are not being implemented universally or to scale, and this has costs - both for women and for our health care system."

Thomas Goss, PharmD, Senior Vice President at Veranex (formerly Boston Healthcare Associates) and a study co-author added, "My colleagues, Manasi Datar, Ph.D., Li-Chen Pan, M.P.H., and I were thrilled to partner with Renovia on these important studies. When we examined the healthcare resource use and cost burden of urinary incontinence to U.S. payers, we found UI-associated costs across the spectrum of care that are negatively impacting payers. These two additional studies build on that first study and begin to highlight factors that likely contribute to the increased costs associated with UI experienced by payers."

The American College of Obstetricians and Gynecologists (ACOG), the American Urogynecologic Society (AUGS), the American Urological Association (AUA), and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU), among others, recommend PFMT as a first-line intervention for UI. They have also developed evidence-based guidelines for the evaluation and treatment of female UI. The leva Pelvic Health System is an FDA-cleared, prescription digital therapeutic (PDT) that combines a small vaginal motion sensor with a smartphone app that guides a woman through PFMT, offering an easy, non-invasive, drug-free way for women to effectively strengthen their pelvic floor muscles to improve UI symptoms. leva requires just five minutes of training a day, which women can do at home, on their own schedule. In April 2022, Obstetrics and Gynecology (The Green Journal), published a randomized controlled superiority study showing that leva was statistically and clinically superior to Kegels alone for improving symptoms of stress and stress-dominant mixed urinary incontinence.

"Deviating from evidence-based evaluation and treatment guidelines for UI is common and costly," said Jessica McKinney, PT, DScPT, MS, Renovia's Vice President of Medical Affairs & Clinical Advocacy and a study co-author. "Adhering to these recommendations and incorporating evidence-based treatments are critical for women with UI, especially given its all-too-common and progressive nature. In addition to improving women's health and well-being, rigorous data show pelvic floor muscle training, including with the leva Pelvic Health System, can significantly improve patient outcomes and patient adherence, and may result in significant cost reductions for our healthcare system."

Neurourology and Urodynamics is the official journal of the Society of Urodynamics and Female Pelvic Medicine & Urogenital Reconstruction.

About the leva® Pelvic Health System

The leva Pelvic Health System offers a novel, 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 connected to a smartphone app, leva 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, leva is available by prescription only, allowing physicians the opportunity to treat UI and chronic FI on a broad scale and with deep involvement in patient success. leva is the first femtech product included in the Digital Therapeutics Alliance product library and has multiple clinical trials and published data from globally recognized medical centers supporting its efficacy. leva received the 2021 Excellence Award for Research from Medical Device Network.

About Renovia

Boston-based Renovia Inc. is a women-led company dedicated to improving the lives of women with pelvic floor disorders. Renovia'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. Renovia'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 about Renovia or leva please visit www.renoviainc.com and www.levatherapy.com and follow us on Twitter, Facebook, LinkedIn and Instagram.

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 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 Veranex

Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance for each of its four concept-through-commercialization pillars — engineering and design, clinical, market access, and regulatory — Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment. At every stage, Veranex customers realize efficiencies in cost and time, while its comprehensive solutions unify the entire development process. Follow Veranex on LinkedIn.

Renovia Inc. and leva® are trademarks or registered trademarks of Renovia Inc. in the United States and other countries. All Rights Reserved.


Source: Renovia

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