Digital health treatment program found safe, effective for urinary incontinence

Data from a real-world evidence study support the safety and effectiveness of the Leva Pelvic Health System, a digital health treatment program that provides access to pelvic floor muscle training (PFMT) for patients with urinary incontinence.¹

Overall, 74% of patients included in the study reported symptom improvement.

“Real-world evidence is critically important in women’s health, particularly for behavioral interventions like pelvic floor muscle training where treatment adherence is low. These study findings add to the growing body of published data showing that women can access PFMT successfully using the Leva System. Alignment between randomized controlled trial findings and real-world studies underscores the strength of both data sets. We believe the collective findings are unique in urogynecology and offer strong evidence that first-line incontinence treatment is effective, and women can access it using the Leva System,” said lead author Evelyn Hall, MD, in a news release on the findings.² Hall is a urogynecologist and female pelvic reconstructive surgeon at Tufts Medical Center as well as an assistant professor at Tufts University School of Medicine in Boston, Massachusetts.

The Leva Pelvic Health System is FDA-cleared for the treatment of women with stress, urgency, and mixed urinary incontinence as well as in the first-line treatment of patients with chronic fecal incontinence. The system works by using real-time visualization of the patients’ pelvic movement to guide PFMT. The program is designed to be used for just 5 minutes per day and is available through prescription only. For the real-world evidence study, patients were prescribed to the training program on a regimen of 2.5 minutes twice daily.

Overall, 74% of patients included in the study reported symptom improvement. This finding was similar when patients were stratified by age, body mass index (BMI), and incontinence subtype. Patients were more likely to report symptom improvement if they used the device for 10 or more times per week.

At baseline, the average Urogenital Distress Inventory Short Form (UDI-6) score was 46.8 (SD, 19.3) among all patients. The average change in UDI-6 score was 11.3 (SD, 19.9; P < .001). Baseline incontinence symptom severity and maximum angle change during pelvic floor muscle contraction were significantly associated with meeting the UDI-6 minimum clinically important difference per multivariate logistic regression analysis. Age, BMI, and incontinence subtype were not associated.

Among all patients, the average adherence to the treatment regimen was 89% over 12 weeks, with the number of average weekly uses being 12.5 (SD, 2.1), of 14 possible. In total, 92.9% of users in the study adhered to the prescribed regimen.

The retrospective, real-world cohort study enrolled a total of 947 adult women with either stress, urgency, or mixed urinary incontinence who initiated device use between January 1, 2022 and June 30, 2023. The primary objective of the study was to assess the effectiveness and safety of the program in patients with incontinence. Secondary objective measures were to evaluate patient engagement following an updated user platform and to identify factors predictive of success.

The Leva System is guided by an intravaginal motion-based device that pairs with a smartphone app, which collects data on patient-reported demographics and outcomes, adherence to the regimen, and pelvic floor muscle parameters consisting of angle change and hold time. Symptom improvement was measured by UDI-6 score change from baseline to the most recent score.

Based on these data, the authors concluded, “A digital PFMT program completed with visual guidance from a motion-based device yields significant results when executed ≥10 times per week over a period of 12 weeks…First-line incontinence treatment, when implemented using this digital program, leads to statistically and clinically substantial symptom improvements across age and BMI categories and incontinence subtypes.”¹

References

1. Hall E, Keyser L, McKinney J, Pulliam S, Weinstein M. Real-world evidence from a digital health treatment program for female urinary incontinence: Observational study of outcomes following user-centered product design. JMIR Form Res. 2024 27:8:e58551. doi:10.2196/58551

2. Axena Health shares new publication that adds more real-world evidence for the Leva Pelvic Health System. News release. Axena Health, Inc. July 9, 2024. Accessed July 10, 2024. https://axenahealth.com/2024/07/axena-health-shares-new-publication-that-adds-more-real-world-evidence-for-the-leva-pelvic-health-system/