BOSTON--(BUSINESS WIRE)--Renovia Inc. (“Renovia”), a company dedicated to discovering and delivering first-line digital therapeutic and diagnostic device and app technologies for women with pelvic floor disorders, today announced the publication of data from a pilot study of the leva® Pelvic Digital Therapeutic showing statistically significant improvement in (1) objective pelvic floor muscle (PFM) measures, (2) patient-reported urinary incontinence (UI) severity, and (3) condition-specific quality of life. The results were published online in Neurourology and Urodynamics in an article titled, “Evaluation of an accelerometer-based digital health system for the treatment of female urinary incontinence: A pilot study.”
The pilot study, referred to as “Ren-01,” included adult women with stress UI or stress-dominant mixed UI. Subjects performed PFM exercises guided by the leva Pelvic Digital Therapeutic for 2.5 minutes twice daily for six weeks. The study’s goal was to evaluate the effectiveness and usability of Renovia’s accelerometer-based therapeutic technology in improving PFM function, UI symptoms and related quality of life measures.
During the six-week study, participants reported a statistically significant reduction in UI symptoms and in the negative impact of UI while performing daily activities. In addition, participants reported a reduction in symptoms on all measures after the first week of training. Subjects also reported the leva device to be easy to use over the six-week study.
More specific results at the end of the study include the following:
- 87% of subjects (20/23) indicated the resolution of stress UI symptoms, as measured by UDI-6 scores.1
- All subjects with mixed UI reported resolution of the urgency UI component.
- Subjects’ mean IIQ-7 scores improved by 99% with only one subject reporting mild frustration regarding incontinence and no subjects reporting any other negative impact in any IIQ-7 category.2
- 74% of subjects (17/23) reported high levels of improvement in general UI symptoms, based on PGI-I scores.3
- All subjects (23/23) reported some measure of improvement in general UI symptoms, based on PGI-I scores.
The study also found statistically significant changes in objective measures of PFM function. Subjects’ mean maximum duration of PFM lifting exercises (an endurance measure that is effectively a PFM “plank”) increased by 174.8 seconds over the six weeks. Subjects’ mean maximum number of repeated contractions performed within 15 seconds increased by 3.7 repetitions (from 5.9 to 9.7) during the study.
“As a surgeon, I’m acutely aware of the gap in effective first-line treatments for UI so when I was approached about the Ren-01 study, I was intrigued by the potential of Renovia’s movement-based sensor and app technology,” said Peter Rosenblatt, MD, Assistant Professor of Obstetrics and Gynecology at Harvard Medical School, Director of Urogynecology and Pelvic Reconstructive Surgery at Mount Auburn Hospital and Principal Investigator for the Ren-01 study. “I am very excited to see these compelling results from a 23 subject pilot study. Since the completion of the study, I have prescribed leva to my patients for their at-home use and have been pleased with the positive symptom results.”
Samantha Pulliam, MD, Chief Medical Officer at Renovia, added, “Renovia’s intent when designing the Ren-01 study was to start generating clinical data on leva’s mechanism of action, which allows a woman to visualize the movement of her pelvic floor muscles as she exercises them. The fact that the data shows statistically significant improvement across so many different symptom measures really speaks to the efficacy of leva’s integrated device and smart-phone app technology. Having treated women with pelvic floor disorders for over 20 years, I’m thrilled to be part of a team that is providing treatment options with the potential to transform the standard of care for UI and other pelvic floor disorders.”
The study included premenopausal adult women who indicated stress UI or stress-dominant mixed UI. Subjects performed PFM exercises guided by the leva Digital Therapeutic for 2.5 minutes twice daily for six weeks. Weekday daytime training sessions (5/week) took place at an outpatient clinic and were supervised by the same research assistant trained in the use of the device. Unsupervised, at-home weekend and evening sessions consisted of the same regimen.
Further study details are included in the published article, available at https://doi.org/10.1002/nau.24097.
About Urinary Incontinence
UI affects an estimated 20 million women in the U.S.4 and an estimated 250 million women worldwide.5 UI can have a negative impact on quality of life and lead to potentially severe medical conditions. Despite its prevalence and adverse effects on women’s health, UI is often underreported by women and thus not addressed by clinicians. Fortunately, groups such as ACOG (American College of Obstetricians and Gynecologists) and WPSI (Women’s Preventive Services Initiative) are increasingly recommending screening for pelvic floor disorders including UI.6 Early intervention has been shown to resolve or reduce symptoms, improve immediate and long-term condition-specific quality of life, and limit the need for more invasive and costly treatments.
About Renovia’s leva® Pelvic Digital Therapeutic
Renovia’s leva® Pelvic Digital Therapeutic is an innovative, FDA-cleared device and smartphone app that enables women to have real-time visual verification they are performing their PFM exercises correctly and consistently by guiding women through their treatment. PFM exercises are the widely accepted first-line conservative treatment for pelvic floor disorders including stress, urgency, and mixed UI within the obstetrics and gynecology, urogynecology, urology and physical therapy communities. However, many women have trouble identifying and contracting the correct muscles when performing these exercises, and remembering to perform the exercises regularly can be challenging.
Important Safety Information
The leva® Pelvic Digital Therapeutic is intended for strengthening pelvic floor muscles; and rehabilitation and training of pelvic floor muscles for the treatment of stress, mixed and mild to moderate urgency urinary incontinence (including overactive bladder) in women.
Do not use the 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 leva, see its Instructions for Use available at Renovia’s website. Treatment with leva is prescribed by your doctor and is not for everyone. Please talk to your doctor to see if leva is right for you. Your doctor should discuss all potential benefits and risks with you.
Renovia was formed to develop and commercialize products for better first-line diagnosis and treatment to improve the condition-specific quality of life for millions of women with pelvic floor disorders. Renovia's technology enables treatment via precise visualization of pelvic movement in real time during pelvic floor muscle training, while monitoring usage and progress over time. As a women's health organization, Renovia is in pursuit of scalable and cost-effective care for pelvic floor disorders delivered through the power of digital health. For more information, please visit here.
1 UDI-6, also known as the short-form Urogenital Distress Inventory, is an independent validated symptom questionnaire which indicates overall UI symptom distress, combining irritative symptoms, stress symptoms, and obstructive/discomfort symptoms.
2 IIQ-7, also known as the short-form Incontinence Impact Questionnaire, is an independent validated questionnaire to assess the quality of life impact of UI, including UI’s impact on physical activity, travel, social activities, household activities, social activities, emotional health, and feelings of frustration.
3 PGI-I, short for Patient Global Impression of Improvement, is an independent validated questionnaire to assess outcome measures in studies evaluating the efficacy of treatments in medical and psychiatric conditions with subjective symptom domains.
4 Wu, J. M., Hundley, A. F., Fulton, R. G., & Myers, E. R. (2009). Forecasting the Prevalence of Pelvic Floor Disorders in U.S. Women. Obstetrics & Gynecology, 114(6), 1278–1283.
5 Irwin D.E., Kopp Z.S., Agatep B., Milsom I., & Abrams P. (2011). Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction in British Journal of Urology, 108(7):1132-8.
6 See ACOG Committee Opinion No. 736 issued in May 2018, and WSPI Clinical Guidelines published in September 2018.