Study to explore barriers to incontinence care

Axena Health has launched a study to examine the barriers that patients face in seeking treatment for urinary incontinence and fecal incontinence, the company announced in a news release.¹

n addition to the current study, Axena Health also launched a global study in May 2023 to explore the burdens of incontinence for women in low- and middle-income countries.

“Professional societies and medical guidelines recommend conservative, first-line treatment for urinary and fecal incontinence. A growing body of published data shows that [urinary incontinence] and [fecal incontinence] often go untreated. When they are treated, patients often skip to advanced therapies such as medications and surgery. My hope is that our study will help us better understand the patient journey and the barriers to first-line, conservative care,” said Axena Health CEO Eileen Maus in the news release.¹

The real-world study plans to enroll 500 patients who are utilizing the Leva Pelvic Health System, a non-invasive medical device to help women train and strengthen pelvic floor muscles for the management of urinary incontinence and chronic fecal incontinence. The device could help serve as an accessible first-line treatment option for women with these conditions.

“While Kegels are accessible, they don’t work for most women,” said Annette Brewster, Axena Health’s vice president of patient services and commercial operations, in the news release.¹ “Physical therapy can help, but it’s not widely accessible. The Leva System offers an at-home alternative so women can access effective [pelvic floor muscle training] privately, on their own schedule. We’re working hard to ensure that all women have access to the Leva System and hope this study will help us continue to convince payers and providers to support women’s access to effective, convenient first-line treatment.”

The real-world study is currently enrolling participants.

In addition to the current study, Axena Health also launched a global study in May 2023 to explore the burdens of incontinence for women in low- and middle-income countries.²

The study began in Nigeria and Kenya and is working to gain insight from women with incontinence, as well as their families and clinicians, on the stigmas, symptoms, and treatment access within local health care delivery systems. The second phase of the study is expected to include additional countries in Africa and South Asia and include formation and implantation research based on insights from the first phase of the study.

Data on the Leva Pelvic Health System

The Leva Pelvic Health System combines an FDA-cleared vaginal motion sensor device and integrated software to help women train and strengthen their pelvic floor muscles. The device is intended to be used for 5 minutes a day.

Data on the device were presented at the International Urogynecological Association’s annual meeting in The Netherlands on June 21-24, 2023.³ The study included 363 women with stress or stress-dominant mixed urinary incontinence who completed either pelvic floor muscle training guided by the motion-based therapeutic device or a home program with written/video instructions.

Overall, data showed that inclusion of the device provided durable and significantly greater improvements in urinary incontinence symptoms compared with at-home pelvic floor muscle training alone.Further, 8 weeks of treatment with the device was shown to provide symptom improvement through 18 months (P = .02) and available 24-month data (P = .042), even in the absence of active exercise.

The study remains ongoing to assess 2-year outcomes.

References

1. Axena Health studies barriers to first-line treatment for urinary incontinence. News release. Axena Health. Published online and accessed January 22, 2024. https://www.businesswire.com/news/home/20240122302008/en/Axena-Health-Studies-Barriers-to-First-Line-Treatment-for-Urinary-Incontinence

3. Axena Health begins first-of-its-kind global study of female incontinence. News release. Axena Health. May 17, 2023. Accessed January 22, 2024. https://axenahealth.com/2023/05/axena-health-begins-first-of-its-kind-global-study-of-female-incontinence/

3. Weinstein MM, Dunivan G, Guaderrama NM, Richter HE. 18- and 24-month follow-up of a randomized controlled trial comparing 8 weeks of pelvic floor muscle training guided by a digital therapeutic device versus home program. 48th Annual Meeting of the Urogynecological Association. The Netherlands. June 21-24, 2023. Abstract 001