Michael Barbella, Managing Editor08.28.23
Axena Health Inc. has introduced the Leva Pelvic Health System for the first-line treatment of chronic fecal incontinence (FI), also called accidental bowel leakage (ABL), in women. The U.S. Food and Drug Administration (FDA) cleared the new indication last year after the product received Breakthrough Device Designation in 2021. New coaching and education support along with updates to the Leva System app combine to support its use for chronic FI, making access to first-line treatment easy and practical.
Defined as the uncontrolled passage of feces, chronic FI is a progressive condition that has a significant negative impact on sufferers’ quality of life. Existing treatment options are limited, and few are curative. While pelvic floor muscle training (PFMT) is a first-line treatment, difficulty performing PFMT (“Kegels”) correctly often makes it inaccessible, leaving women to endure the depression, shame, guilt, frustration and social isolation that often accompany FI. Less than 30% of women will discuss their FI symptoms with their healthcare provider, which means estimates of those affected are vastly underreported. Despite this, current data show:
“Fecal incontinence is a profoundly debilitating condition for which social stigma is high,” said Milena M. Weinstein, M.D., co-chair, Massachusetts General Hospital, Center for Pelvic Floor Disorders; program director, Female Pelvic Medicine and Reconstructive Surgery Fellowship; associate professor of Gynecology and Reproductive Biology at Harvard Medical School, and pilot study investigator. “Treatment options are very limited, leaving many women to endure symptoms silently. In our study, we showed the Leva System had the potential to improve fecal incontinence symptoms, which gives both clinicians and women an easy, practical way to access first-line treatment. I and the study authors continue to advance the data supporting the Leva System’s treatment efficacy for FI as well as the data supporting its efficacy for UI. As these conditions often co-occur, a single, non-invasive treatment option for both could offer significant benefits for patients and clinicians.”
The FDA originally cleared the Leva Pelvic Health System in 2019 for treating stress, mixed and mild-to-moderate urgency urinary incontinence (UI). Since that time, researchers have amassed strong clinical data supporting its efficacy in treating UI, including two studies published in Obstetrics and Gynecology (The Green Journal). The first publication, an eight-week randomized controlled superiority trial (RCT) showed the Leva System significantly improved symptoms of UI in women compared to PFMT alone. The second Green Journal publication, a one-year longitudinal follow up from the RCT, showed that women who used the Leva System for eight weeks achieved long-term (12 month), durable UI symptom relief.
“Pelvic floor muscle training is a first-line treatment for both urinary and fecal incontinence,” Axena Health Chief Medical Officer Samantha Pulliam, M.D., said. “Historically, devices that supported PFMT for FI have relied on anal feedback. The Leva System uses vaginal biofeedback, which we believe makes it more comfortable and tolerable for women. Thousands have used it to relieve symptoms of urinary incontinence, and we aspire to saying the same for women who experience fecal incontinence. As always, we’re committed to advancing the research supporting use of the Leva System for both conditions and will continue to support clinicians with the only device that treats UI and FI and enables clinician-supervised remote or at-home PFMT.”
The Leva Pelvic Health System is a prescription medical device available in the United States that offers a 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 and chronic fecal incontinence. Combining a small FDA-cleared vaginal motion sensor connected to a smartphone app, the Leva System offers precise visualization of pelvic movement in real-time, enables progress tracking and allows active clinician involvement, all of which support women’s success.
“Pelvic floor muscle training offers simple, non-invasive treatment for both urinary and fecal incontinence, but accessing it can be hard for many reasons,” Axena Health CEO Eileen Maus stated. “We believe women deserve non-invasive, drug-free treatment options, and we believe they should be easy to access and backed by the most rigorous data in medicine. We are committed to delivering this for women living with UI, FI or both. With so many unwilling or unable to speak about symptoms with their healthcare provider, the shame factor is clear, and this compels us to do more.”
Axena Health Inc. is a women-led company dedicated to improving the lives of women with pelvic floor disorders.
Defined as the uncontrolled passage of feces, chronic FI is a progressive condition that has a significant negative impact on sufferers’ quality of life. Existing treatment options are limited, and few are curative. While pelvic floor muscle training (PFMT) is a first-line treatment, difficulty performing PFMT (“Kegels”) correctly often makes it inaccessible, leaving women to endure the depression, shame, guilt, frustration and social isolation that often accompany FI. Less than 30% of women will discuss their FI symptoms with their healthcare provider, which means estimates of those affected are vastly underreported. Despite this, current data show:
- Nine percent of women report monthly FI.
- Nineteen percent report less frequent FI.
- Less than 3% of women with self-reported FI receive a clinical diagnosis.
- FI is a leading cause of nursing home placement for older women.
- Women with FI are more likely to also have urinary incontinence (UI).
“Fecal incontinence is a profoundly debilitating condition for which social stigma is high,” said Milena M. Weinstein, M.D., co-chair, Massachusetts General Hospital, Center for Pelvic Floor Disorders; program director, Female Pelvic Medicine and Reconstructive Surgery Fellowship; associate professor of Gynecology and Reproductive Biology at Harvard Medical School, and pilot study investigator. “Treatment options are very limited, leaving many women to endure symptoms silently. In our study, we showed the Leva System had the potential to improve fecal incontinence symptoms, which gives both clinicians and women an easy, practical way to access first-line treatment. I and the study authors continue to advance the data supporting the Leva System’s treatment efficacy for FI as well as the data supporting its efficacy for UI. As these conditions often co-occur, a single, non-invasive treatment option for both could offer significant benefits for patients and clinicians.”
The FDA originally cleared the Leva Pelvic Health System in 2019 for treating stress, mixed and mild-to-moderate urgency urinary incontinence (UI). Since that time, researchers have amassed strong clinical data supporting its efficacy in treating UI, including two studies published in Obstetrics and Gynecology (The Green Journal). The first publication, an eight-week randomized controlled superiority trial (RCT) showed the Leva System significantly improved symptoms of UI in women compared to PFMT alone. The second Green Journal publication, a one-year longitudinal follow up from the RCT, showed that women who used the Leva System for eight weeks achieved long-term (12 month), durable UI symptom relief.
“Pelvic floor muscle training is a first-line treatment for both urinary and fecal incontinence,” Axena Health Chief Medical Officer Samantha Pulliam, M.D., said. “Historically, devices that supported PFMT for FI have relied on anal feedback. The Leva System uses vaginal biofeedback, which we believe makes it more comfortable and tolerable for women. Thousands have used it to relieve symptoms of urinary incontinence, and we aspire to saying the same for women who experience fecal incontinence. As always, we’re committed to advancing the research supporting use of the Leva System for both conditions and will continue to support clinicians with the only device that treats UI and FI and enables clinician-supervised remote or at-home PFMT.”
The Leva Pelvic Health System is a prescription medical device available in the United States that offers a 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 and chronic fecal incontinence. Combining a small FDA-cleared vaginal motion sensor connected to a smartphone app, the Leva System offers precise visualization of pelvic movement in real-time, enables progress tracking and allows active clinician involvement, all of which support women’s success.
“Pelvic floor muscle training offers simple, non-invasive treatment for both urinary and fecal incontinence, but accessing it can be hard for many reasons,” Axena Health CEO Eileen Maus stated. “We believe women deserve non-invasive, drug-free treatment options, and we believe they should be easy to access and backed by the most rigorous data in medicine. We are committed to delivering this for women living with UI, FI or both. With so many unwilling or unable to speak about symptoms with their healthcare provider, the shame factor is clear, and this compels us to do more.”
Axena Health Inc. is a women-led company dedicated to improving the lives of women with pelvic floor disorders.