Improve the symptoms of urinary incontinence with leva®

leva® is a new clinically proven, prescription-only treatment option for urinary incontinence, a serious medical condition that affects over 60% of your female members.1

How leva® works

leva® is an at-home, easy-to-use software-driven pelvic health program that can help women strengthen their pelvic floor muscles and decrease their symptoms of urinary incontinence.

Wand with Motion Sensors + App

Inserted vaginally, the leva wand uses motion sensors to detect movement during pelvic floor muscle training, and communicates with the app to direct treatment and provide real-time feedback.

leva Women's Center

The leva system is supported by the leva Women's Center, a team of coaches who help patients with training, adherence and personal symptom goals.

Patient Remote Monitoring Physician Report

The report captures the adherence and symptom data that providers need to monitor patient progress over time.

Leva Health Plans Graphic

Indication

The leva® Pelvic Health System is prescription-only and FDA-cleared for the treatment of stress, mixed and mild to moderate urgency urinary incontinence, including overactive bladder.

 

Prescription Reimbursement Identifier

60002099440

leva Journal Graphic

Clinical outcomes

Published in Obstetrics & Gynecology (“The Green Journal”), our pivotal 8-week randomized controlled trial (RCT) with 299 women demonstrates that pelvic floor muscle training guided by leva delivers better UI symptom improvement than Kegels alone.2 Primary outcomes were change in stress urinary incontinence (SUI) episodes on a 3-day bladder diary and change in Urogenital Distress Inventory (UDI-6) score.

  • The 3-day bladder diary results showed that the median number of SUI episodes at 8 weeks was significantly fewer in the leva arm than in the Kegel arm. Quantitatively, leva users saw their leaking episodes decrease from nearly 2 leaks every day to 1 leak every 3 days.2
  • For the (UDI-6) scores on symptom relief, the leva users reached a significantly greater score improvement compared to the Kegel arm. In fact, leva users saw their scores drop from 52.9 to 36.3, a level which is likely no longer bothersome to most patients.2,3
  • The leva users saw statistically significant symptom improvement as early as 4 weeks into treatment.2
Read study

Plan savings with leva

Publications

Several publications support the finding that UI is costly and undertreated, and there is a real lack of documented first line care.

Resource Utilization/Cost to Payers

Conclusion: Women with SUI/MUI consume significantly higher medical resources and incur higher costs to health plans, compared to women without SUI/MUI. While reasons for this are not fully understood, improved and standardized treatment for women with SUI/MUI may positively affect cost and outcomes.

Status: Published; Neurourol Urodyn. 2022; 1-10. doi:10.1002/nau.24989

Care Pathway Adherence

Conclusion: Majority of SUI or MUI patients do not receive a behavioral intervention as their first-line treatment, which is a recommendation by professional society guidelines. This was found to affect the cost burden for health plans; those that were non-adherent had significantly higher costs 2-years post-index.

Status: Accepted; Neurourol Urodyn – publication date TBD

Utilization of Pelvic Floor PT

Conclusion: Percentage of women with a PT visit associated with an incident SUI or MUI diagnosis was low (2.6%), and 30% of this group completed three or more PT visits. This suggests poor adherence to clinical guidelines regarding supervised treatment of UI in women.4

Status: Published; Neurourol Urodyn. 2022; 1-8. doi:10.1002/nau.24913

Economic impact to the plan - Savings opportunity through offering improved first-line care for members with leva vs. historic standard of care (SOC)*

*PFMT supervised by a PT or unsupervised Kegels

Examples
Plan Savings Chart
Key Takeaways

Cost savings with leva within UI standard of care

  • Majority of savings from decreased utilization of advanced treatments
  • Improved care and systematic cost savings

Increased utilization of leva should lead to lower costs for health plans

leva can be reimbursed as either a pharmacy benefit or a medical benefit

Pharmacy benefit advantages:
Pharmacy Benefit Advantages Chart

Interested in learning more about urinary incontinence?

Contact us today to learn about the benefits of leva

References
  1. 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
  2. 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.
  3. Sanderson DJ, Zavez A, Meekins AR, Eddib A, Lee TG, Barber MD, Duecy E. The Patient Acceptable Symptom State in Female Urinary Incontinence. Female Pelvic Med Reconstr Surg. 2022 Jan 1;28(1):33-39. doi: 10.1097/SPV.0000000000001055. PMID: 34009829.
  4. McKinney, JL, Datar, M, Pan, L-C, Goss, T, Keyser, LE, Pulliam, SJ. Retrospective claims analysis of physical therapy utilization among women with stress or mixed urinary incontinence. Neurourol Urodyn. 2022; 1- 8. doi:10.1002/nau.24913
Important Safety Information

The leva Pelvic Health System is intended for: (i) strengthening of the pelvic floor muscles; and (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. This product interacts with the user via smartphone technology.

Important Safety Information for 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 wand in your body for longer than necessary to complete the training session. Remove the 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 leva 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 leva, see its Instructions for Use available at Renovia’s website. Treatment with 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

Renovia 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 Renovia by the original purchaser prior to the end of the warranty. Warranty claims must be supported with reasonable evidence of the claimed defect. Renovia 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 Renovia.

Renovia reserves 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 Renovia’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. RENOVIA 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, RENOVIA LIMITS THE DURATION AND REMEDIES OF SUCH WARRANTIES TO THE DURATION OF THIS EXPRESS WARRANTY AND, AT RENOVIA’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 Renovia to confirm the terms of this Limited Warranty prior to purchase. Renovia reserves the right, at its discretion, to modify its terms at any time prior to your purchase.