Renovia Reports Published Studies Find Low Documented Adherence to Guideline-based Care for Female SUI

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.