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A serious medical condition that your patients aren’t talking to you about
If left untreated, urinary incontinence (UI), is associated with physical decline2,3 and may negatively impact measures of cognitive function4,5 and social and emotional well-being.6,7
Get factsThe challenges of pelvic floor muscle training
Pelvic floor muscle training (PFMT) is globally recommended as part of first-line treatment for UI8 and proven to work, but most women don’t perform their exercises correctly, or at all.9
Over 60% of U.S. women experience UI10
As few as 25% of women with UI seek treatment from their healthcare professional11
Women with UI are at a 30% greater risk of hospitalization12
Women with UI are 2x as likely to be admitted to a nursing facility12
Backed by science, leva is proven to work
Clinical data supports the use of leva for patients with stress, mixed, and urgency UI, including overactive bladder. In our randomized controlled trial with 299 women, the leva group achieved significantly greater improvement on both primary endpoints vs. the Kegels group.1
See the data3 day bladder diary:
leva users reported significantly fewer SUI episodes at 8 weeks
UDI-6 scores:
leva users achieved significantly greater symptom improvement at 8 weeks
Improve your patients’ pelvic health with leva®
leva is an at-home easy-to-use pelvic health system that can help your patients strengthen their pelvic floor muscles and decrease their symptoms of UI.
Inserted vaginally, the flexible leva wand is embedded with motion sensors along the length of the device that detect movement during pelvic floor muscle training.
leva can be easily incorporated into your practice
Introduce your UI patients to leva today. Here’s how to get started.
Identify the patients who could benefit from treatment.
Complete the prescription form and email or fax it to the leva Women’s Center.
Inform your patient that the leva Women’s Center will contact her in 1–2 business days.
Meet our experts
Samantha (Mandy) Pulliam, MD
Chief Medical Officer
Currently chief medical officer at Renovia, Dr. Pulliam previously served as an assistant professor of obstetrics and gynecology and division director for urogynecology and pelvic reconstructive surgery at the University of North Carolina at Chapel Hill School of Medicine.
Jessica McKinney, PT, DScPT, MS
VP, Medical Affairs & Clinical Advocacy
Prior to joining Renovia, Dr. McKinney served as director of The Center for Pelvic and Women’s Health for Marathon Physical Therapy & Sports Medicine. Since 2009, she has developed programs in obstetric fistula rehabilitation and pelvic and women’s health in low-income countries.
Laura Keyser, DPT, MPH
Senior Manager, Medical Affairs
Dr. Keyser brings 10+ years of clinical expertise in women’s health, pelvic health and child health and development to Renovia. She’s a seasoned researcher, writer, speaker and educator focused on reducing health disparities, improving population-level health literacy, and advocating for gender equity and human rights.
Get the resources you need to treat UI
We offer valuable resources, for you, your practice, and your patients.
Care Pathway
Use this tool to help you discuss UI treatment options and the role that pelvic floor muscle training plays in treatment/pelvic health.
Patient Brochure
Provide your patients with more information about UI and how pelvic floor muscle training with leva works.
Prescription Form
We make it easy for you to prescribe leva for your patients with this straightforward order form.
New RCT shows that leva® is statistically superior to Kegels alone
Published in Obstetrics & Gynecology (“The Green Journal”), our pivotal 8-week randomized controlled trial (RCT) demonstrates that pelvic floor muscle training guided by leva is superior to Kegels alone in improving symptoms of stress and stress-dominant mixed urinary incontinence.
Read studyHelp your patients take control of their pelvic health.
Contact our Provider Support Helpline to learn more.
Contact UsReferences
- Weinstein, MM, Dunivan, G, Guaderrama, NM, Richter, HE. Digital Therapeutic Device for Urinary Incontinence: A Randomized Controlled Trial [published online ahead of print, 2022 March 10]. Obstet Gynecol. doi: 10.1097/AOG.0000000000004725.
- Ca Corrêa L, Pirkle CM, Vafaei A, Curcio CL, Câmara SM. Urinary incontinence is associated with physical performance decline in community-dwelling older women: results from the International Mobility in Aging Study (IMIAS). doi:10.1177/0898264318799223.
- Parker-Autry C, Houston DK, Rushing J, et al. Characterizing the functional decline of older women with incident urinary incontinence. Obstet Gynecol. 2017;130(5):1025-1032. doi:10.1097/AOG.0000000000002322.
- Hamana T, Dantas DM, Castaneda L, Dantas DDS. Functioning and disability of premenopausal women with urinary incontinence: An assessment by using the World Health Organization Disability Assessment. Neurourol Urodyn. 2019;(May). doi:10.1002/nau.24073.
- Lussier M, Renaud M, Chiva-Razavi S, Bherer L, Dumoulin C. Are stress and mixed urinary incontinence associated with impaired executive control in community-dwelling older women? J Clin Exp Neuropsychol. 2013;35(5):445-454. doi:10.1080/13803395.2013.789483.
- Mendes A, Hoga L, Gonçalves B, Silva P, Pereira P. Adult women’s experiences of urinary incontinence: a systematic review of qualitative evidence. JBI database Syst Rev Implement reports. 2017;15(5):1350-1408. doi:10.11124/JBISRIR-2017-003389.
- Siddiqui NY, Wiseman JB, Cella D, et al. Mental health, sleep and physical function in treatment seeking women with urinary incontinence. J Urol. 2018;200(4):848-855. doi:10.1016/j.juro.2018.04.076.
- Favre-Inhofer A, Dewaele P, Millet P, Deffieux X. Systematic review of guidelines for urinary incontinence in women. J Gynecol Obstet Hum Reprod. 2020;49(8):101842. doi:10.1016/j.jogoh.2020.101842.
- Moen MD, Noone MB, Vassallo BJ, Elser DM. Pelvic floor muscle function in women presenting with pelvic floor disorders. Int Urogynecol J. 2009;20(7):843-846. doi:10.1007/s00192-009-0853-6.
- Patel UJ, Godecker AL, Giles DL, Brown HW. Updated Prevalence of Urinary Incontinence in Women: 2015-2018 National Population-Based Survey Data [published online ahead of print, 2022 Jan 12]. Female Pelvic Med Reconstr Surg. 2022;10.1097/SPV.0000000000001127. doi:10.1097/SPV.0000000000001127
- Minassian VA, Yan X, Lichtenfeld MJ, Sun H, Stewart WF. The iceberg of health care utilization in women with urinary incontinence. Int Urogynecol J. 2012;23(8):1087-1093.
- Thom DH, Haan MN, Van Den Eeden SK. Medically recognized urinary incontinence and risks of hospitalization, nursing home admission and mortality. Age and Ageing. 1997;26(5):367-374. doi:10.1093/ageing/26.5.367.
Important Safety Information
The Leva® Pelvic Health System is intended for: (i) strengthening of the pelvic floor muscles; (ii) 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; and (iii) 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. This product interacts with the user via smartphone technology.
Important Safety Information for the Leva Pelvic Health System: Do not share the Leva system. Leva is a single-user medical device. Do not use the Leva Pelvic Health System while pregnant, or if you think you may be pregnant, unless authorized by your healthcare provider. Do not leave the Leva vaginal wand in your body for longer than necessary to complete the training session. Remove the vaginal wand after each training session. Do not use the Leva Pelvic Health System in any other place in your body. Do not have sexual intercourse while the vaginal wand is inserted. If you experience odor, fever, vomiting, diarrhea, any signs of infections or any flu-like symptoms, contact your doctor immediately. If you experience redness or swelling near the insertion area, or signs of an allergic reaction, contact your healthcare provider immediately For a complete summary of the risks and instructions for the Leva System, see its Instructions for Use available at www.levatherapy.com. Treatment with the Leva Pelvic Health System is prescribed by your healthcare provider. This treatment is not for everyone. Please talk to your healthcare provider to see if it is right for you. Your healthcare provider should discuss all potential benefits and risks with you.
Limited Warranty
Axena Health warrants the leva® Pelvic Health System (“leva” or the “device”) against defects in materials and workmanship for six (6) months from the date of original purchase. Alleged defects must be reported to Axena Health by the original purchaser prior to the end of the warranty. Warranty claims must be supported with reasonable evidence of the claimed defect. Axena Health may require the device be returned and if required, will provide customer with a Return Material Authorization number, which must be displayed on the outside packaging sent to Axena Health.
Axena Healthreserves the right to determine whether to repair or replace a device determined to be defective. In the event of replacement, the warranty period of the replacement device will be run from the date of the original purchase. Repair or replacement of your device will not extend the time period of this limited warranty.
This limited warranty does not cover cosmetic or battery deterioration or damage caused by excessive wear and tear, physical or natural destruction, accident, misuse, neglect or other external causes. Any attempt to disassemble the device will invalidate this limited warranty and any use of the device that is contrary to its Instructions for Use (available on Axena Health ’s website) may invalidate this limited warranty.
REPAIR OR REPLACEMENT OF THE DEVICE OR ITS AFFECTED COMPONENT ARE THE EXCLUSIVE REMEDIES PROVIDED IN CONJUNCTION WITH THE PURCHASE AND USE OF THE DEVICE. TO THE EXTENT PERMITTED BY LAW, THIS WARRANTY AND THE REMEDIES SET FORTH ARE EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES, REMEDIES AND CONDITIONS, WHETHER ORAL, WRITTEN, STATUTORY, EXPRESS OR IMPLIED. AXENA HEALTH DISCLAIMS ALL STATUTORY AND IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND WARRANTIES AGAINST HIDDEN OR LATENT DEFECTS. IN SO FAR AS SUCH WARRANTIES CANNOT BE DISCLAIMED, AXENA HEALTH LIMITS THE DURATION AND REMEDIES OF SUCH WARRANTIES TO THE DURATION OF THIS EXPRESS WARRANTY AND, AT AXENA HEALTH ’S OPTION, REPAIR OR REPLACEMENT AS DESCRIBED ABOVE. SOME STATES DO NOT ALLOW CERTAIN WARRANTY LIMITATIONS, SO THE LIMITATION DESCRIBED ABOVE MAY NOT APPLY TO YOU.
Please contact Axena Healthto confirm the terms of this Limited Warranty prior to purchase. Axena Healthreserves the right, at its discretion, to modify its terms at any time prior to your purchase.