Published health economics study shows improved treatment for female urinary incontinence may have positive effect on patient outcomes and healthcare costs

Improved access to treatment for UI can positively affect women's health and reduce payer costs

BOSTON, June 21, 2022 /PRNewswire/ -- Renovia Inc. (Renovia), a women-led company that develops digital therapeutics for female pelvic floor disorders, announced today that a recent peer-reviewed, published study showed that women with stress urinary incontinence (SUI) and mixed urinary incontinence (MUI) consume significantly more medical resources and incur higher costs to payers, compared to women without SUI/MUI.  The study was published in Neurourology and Urodynamics, the official journal of the Society of Urodynamics and Female Pelvic Medicine & Urogenital Reconstruction.

The study, "Healthcare Resource Use and Cost Burden of Urinary Incontinence to United States Payers," assessed healthcare resource utilization and costs for female patients diagnosed with stress or mixed urinary incontinence (SUI/MUI) compared to a 1:1 matched cohort of patients without SUI/MUI. Over a two-year period, the group of women with SUI/MUI had significantly more inpatient, outpatient, primary care and specialist visits compared to the group of women without incontinence. In fact, payers incurred 61% greater total costs for the women with SUI/MUI. While reasons for the greater resource utilization and costs are multifactorial and, therefore, hard to isolate, the study authors concluded that "Enhanced attention to evaluation and treatment of UI by payers and health systems may present an opportunity to decrease overall medical costs and improve health among women with UI."

Urinary incontinence (UI) is a highly prevalent health condition experienced by over 60% of adult women. UI is characterized by involuntary leakage of urine and is classified into several subtypes, the most common being stress, urgency, and mixed, which comprise approximately 95% of UI diagnoses. Stress UI (SUI) involves leakage with 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.

"This is an important study that confirms what pelvic floor reconstruction surgeons, like myself, have intuitively known for years. UI is a progressive condition and ignoring or dismissing symptoms is never the right answer for the patient, much less at a population health level," noted Dr, Tanaz Ferzandi, the Division Director for Urogynecology & Pelvic Reconstructive Surgery and Associate Professor of Obstetrics and Gynecology at Keck School of Medicine at University of Southern California. "I've seen a tendency across the healthcare ecosystem to think of UI as a lifestyle problem that is largely addressed over the counter with adult diapers and pads, sometimes pessaries. This study provides support that UI is a payer and healthcare system level issue."

Adverse quality of life, economic, and health impacts have been well documented among women with untreated UI. It is a progressive health condition, more likely to worsen over time than to stabilize or resolve when untreated. Multiple studies show that Pelvic Floor Muscle Training (PFMT), commonly referred to as Kegel exercises, can offer effective, first-line treatment for urinary incontinence. However, most women cannot strengthen and train their pelvic floor effectively by performing Kegels on their own.

"Urinary incontinence places a tremendous burden on patients, including an estimated 70% of the cost of conservative care and UI symptom management, and now this study adds to our understanding of the significant costs incurred by payers," said Jessica McKinney, PT, DScPT, MS, Renovia's Vice President of Medical Affairs & Clinical Advocacy and an author on this study. "It is imperative to provide women access to effective, evidence-based UI treatments at every step of the care pathway. Multiple studies have demonstrated the efficacy and safety of the leva Pelvic Health System, an easy, first-line treatment for UI used by women at home, making it a valuable way to improve the symptoms of UI before they progress and lead women to seek additional care."

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 treatment, 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.

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). 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 clinician 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 clinicians the opportunity to treat UI 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 in treating UI. 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), an underreported condition affecting 78 million women in the U.S. alone. 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 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.

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

SOURCE Renovia Inc.

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