FAQs

The Leva Pelvic Health System is FDA-cleared for: (1) rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed, and mild to moderate urgency urinary incontinence (including overactive bladder) in women; (3) rehabilitation and training of weak pelvic floor muscles for the first-line treatment of chronic fecal incontinence (≥3-month uncontrolled passage of feces) in women; and  (3) strengthening of female pelvic floor muscles.

No, Leva requires a prescription from your licensed healthcare provider. A prescription can also be obtained through an evaluation by a telehealth provider by visiting www.levarx.com.

Leva is covered by various national and regional health insurance providers.  Insurance plans vary, as well as applicable deductible, co-pays and co-insurance, which is why the Leva Women’s Center will conduct a benefits verification/check as part of their free consultation offered to every woman who receives an Rx for the Leva Pelvic Health System.  If you have any questions, you can contact the Leva Women’s Center at 855-538-2594 or at support@levacares.com.

We do not offer co-pay assistance; however, Leva is HSA/FSA eligible. We also offer interest-free payment plans, and other programs to help defray the cost of Leva. Our Leva Women’s Center works with women to get them the most affordable option to move forward with the Leva Pelvic Health System. We also have a money-back guarantee* for those who are eligible if truly not happy with Leva.

*Ask our Leva Women’s Center for more details.

Your healthcare provider may or may not request a follow up appointment after prescribing the Leva Pelvic Health System to review your symptoms. Your provider will receive patient reports every four weeks for each patient they have on Leva therapy, which provides adherence and symptom improvement data. Please follow the guidance of your healthcare provider.

Once you’ve chosen to move forward with the Leva Pelvic Health System, it will be shipped to you by Axena Health’s pharmacy partner. You will receive a discreet box containing your new Leva, a Leva storage case, and a quick start guide to help you get started. 

You will be instructed to download the Leva app. The app contains videos and step-by-step instructions on how to get started with Leva. The Leva Women’s Center will also contact you regarding onboarding and/or to answer any questions that you may have. If you ever have any questions, you can always call customer support at 855-FOR-LEVA.

If any of the following apply to you, it is recommended you discuss with your healthcare provider, as they may indicate that Leva is not right for you:

• If you are unwilling to perform daily exercises for at least eight weeks to address your leakage symptoms.
• If you are pregnant, or if you think you may be pregnant, unless authorized by your healthcare provider.
• If you are less than 6-weeks postpartum, unless authorized by your healthcare provider.
• If you are unable to stand on your own for at least five minutes a day.
• If you do not own a smartphone or have access to one during the time you use Leva.
• If your main pelvic health problem is pelvic pain.
• If you have pain with inserting anything into the vagina or are unable to insert anything into the vagina for other reasons.
• If you have a vaginal bulge that comes to or out of the vaginal opening.

 The Leva Pelvic Health System is FDA-cleared for: (1) rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed, and mild to moderate urgency urinary incontinence (including overactive bladder) in women; (3) rehabilitation and training of weak pelvic floor muscles for the first-line treatment of chronic fecal incontinence (≥3-month uncontrolled passage of feces) in women; and  (3) strengthening of female pelvic floor muscles.  

Leva is covered by various national and regional health insurance providers.  Insurance plans vary, as well as applicable deductible, co-pays and co-insurance, which is why the Leva Women’s Center will conduct a benefits verification/check as part of their free consultation offered to every woman who receives an Rx for the Leva Pelvic Health System.  If you have any questions, you can contact the Leva Women’s Center at 855-538-2594 or at support@levacares.com.

Prescribing the Leva Pelvic Health System is easy. Leva is typically available to prescribe through several EMR systems including Athena, EClinical Works, NextGen and (depending on your practice) Epic.  Search for Renovia as the pharmacy and submit like any other prescription order.  

Alternatively, you can simply fill out an Rx / Certificate of Medical Necessity form and send it to the Leva Women’s Center by Fax at 877.800.4371 or by Email (.pdf file) at fax@levacares.com.

The Leva Pelvic Health System has robust clinical data supporting its safety and efficacy, including (1) a 299-person pivotal randomized controlled trial (RCT) published in ACOG’s Green Journal in April 2022, as well as a follow-up longitudinal analysis to the pivotal RCT looking subjects at 18- and 24-months after treatment published in the International Urogynecology Journal in January 2024; and (2) two peer-reviewed published real world evidence studies looking at the results of, together, over 1,200 women who used Leva.  Visit our clinical data page to learn more.