Leva®

Product Overview

Medical conditions:

Urinary and fecal incontinence in women.

Target patient population:

Women with urinary incontinence, chronic fecal incontinence, and/or pelvic floor muscle weakness who want to improve or resolve these symptoms with at-home pelvic floor muscle training.

What to expect:

Decreased or resolved symptoms of stress, mixed and/or urgency incontinence, including overactive bladder. Decreased or resolved symptoms of fecal incontinence.

Note: for more information, please visit https://www.levatherapy.com/.

Clinical Overview

Indications for use:

The Leva Pelvic Health System is intended for: 1) strengthening of the pelvic floor muscles; 2) 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 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.

Outcomes:

A 299-patient randomized controlled trial comparing use of Leva to an active control group performing at-home pelvic floor muscle training (PFMT) demonstrated that the intervention group (Leva users) achieved greater improvement on both primary endpoints compared to the PFMT-only control group. Participants using Leva report statistically and clinically significant symptom improvement as early as 4-weeks and continued improvement through the 8-week study period, as measured by validated outcome measures. This is consistent with prior published research and subsequently published real world evidence.

Published 6- and 12-month data of this RCT demonstrate continued and durable improvement in UI symptoms, with Leva remaining statistically and clinically superior to the control group, regardless of continuation of exercises after 8-weeks.

Directions:

Leva users are guided by the Leva app to perform 2 1/2 min exercise sessions twice a day for 8-12 weeks, or until they are satisfied with their results. Each exercise session consists of five 15-second work intervals, in which users contract the pelvic floor muscles, followed by five 15-second relaxation periods between work intervals. The Leva motion sensor is placed intravaginally for the duration of the exercise session and is removed immediately after use. Exercise sessions are performed in a standing position.

Risks & warnings:

The Leva Pelvic Health System requires that users can stand independently for 5-minutes and is not suitable for use in a sitting or lying position. Pregnant individuals should only use the Leva in consultation with their obstetric care provider.

Place in therapy:

Leva is used in first-line care and may be used alone or in conjunction with additional therapies.

Product Access

Product description:

The Leva Pelvic Health System consists of an intravaginal motion sensor and an app-based software program. The software program directs exercise performance and dosing, monitors symptoms and outcomes, and provides health education. The motion sensor transmits exercise data to the software program on the user’s smartphone.

Prescription status:

A prescription from a qualified healthcare provider is required

Patient access:

Following prescription fulfillment, individuals will download the Leva app on the Apple app store or Google Play. The device component (Leva motion sensor) will be shipped to them directly in 2-3 days.

Use of this product requires access to:

• internet or wifi
• a smartphone.

Provider access:

Healthcare providers will be provided monthly summary and individual patient reports that reflect adherence to therapy, symptoms, and perceived improvement. These may be used to support short- and long-term follow-up care. All patient data is securely received, stored, and transmitted.

Coverage options:

The Leva Pelvic Health System is FSA/HSA-eligible. The company is actively pursuing reimbursement to ensure patients have increased access to this product.

Product availability:

Leva is available in:

• USA: FDA-cleared Class II Medical Device

Clinical Trials

The provided set of evidence represents a sample of conducted studies. For a comprehensive collection contact manufacturers directly.

• Study Title:Digital Therapeutic Device for Urinary Incontinence: A Longitudinal Analysis at 6 and 12 Months 2023
  Study Design: Randomized Controlled Trial; IRB approved
  Outcomes: This was a planned longitudinal analysis of outcomes for participants in a prospective randomized controlled superiority trial powered to detect a 30% difference between groups that collected primary outcomes at 8-weeks. Of 299 participants analyzed at 8 weeks, 286 (95.7%) returned 6- and 12-month data (151 in the control group, 135 in the intervention group). Standardized and validated patient reported outcomes evaluated in this planned follow-up included change in Urogenital Distress Inventory (UDI-6) score and Patient Global Impression of Improvement (PGI-I). In comparison to the control group, the Leva group demonstrated significantly greater urinary incontinence symptom improvement at 6- and 12-months, demonstrating durability of results. The Leva group achieved greater improvement on both primary endpoints compared to the PFMT-only control group. This included the following:
  • UDI-6: The intervention group reached a significantly greater score improvement compared to the control group from baseline to 6- and 12-months (20.2 ± 20.9 vs 14.8 ± 19.5, P=.03 and 22.7 ± 23.3 vs 15.9 ±20.3, P=.01, respectively).
  • PGI-I: Participants in the intervention group had more than twice the odds of reporting improvement compared to the control group (OR 2.45, 95% CI 1.49–4.00).
• Study Title:A digital health program for treatment of urinary incontinence: retrospective review of real-world user data 2022
  Study Design: Retrospective cohort study of real-world data; IRB approved
  Outcomes:A retrospective cohort study of real-world data was conducted to determine the effectiveness of Leva in reducing urinary incontinence symptoms in real-world users in response to 8-weeks of Leva use. The primary outcome was urinary incontinence symptom change as reported via in-app Urogenital Distress Inventory (UDI-6). 265 participants were included in the analysis, which demonstrated statistically significant improvement from baseline to 8-weeks and 62% of participants met or exceeded the Minimal Clinical Important Difference on the UDI-6, demonstrating clinical significance.
• Study Title: Digital Therapeutic Device for Urinary Incontinence: A Randomized Controlled Trial 2022
  Study Design: Randomized Controlled Trial; IRB approved
  Outcomes: A remotely executed 8-week prospective randomized controlled superiority trial powered to detect a 30% difference between groups was conducted. Data was available for analysis for 299 subjects, 143 in the intervention group (leva users) and 156 in the control group (at-home PFMT without leva). 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 leva group achieved greater improvement on both primary endpoints compared to the PFMT-only control group. This included the following:
  • 3-day bladder diary: Median SUI episodes at 8 weeks were significantly fewer in the intervention group (1, IQR 0-3) than in the control arm (2, IQR 1-4), p=0.005;
  • UDI-6: The intervention group reached a significantly greater score improvement compared to the control group (absolute mean change 18.76 vs. 14.69, p=0.011) at 8 weeks.
• Study Title: Use of a motion-based digital therapeutic in women with fecal incontinence: A pilot study 2021
  Study Design: Single-arm prospective pilot trial; IRB approved
  Outcomes: This 10-week trial enrolled 29 women with ≥ 3 months of fecal incontinence (FI) symptoms to perform pelvic floor muscle training with Leva. 27 women had data available for analysis. Primary outcome was change in FI symptoms as measured by the St. Mark’s score and secondary outcomes included change in FI symptoms on a 2-week bowel diary and FI quality of life (FIQoL).
  • Mean St. Mark’s score was 14.6 (±4.4) at baseline and 11.6 (±5.1) at 10‐weeks (p = 0.005).
  • Total FIQol scores were significantly improved (p < 0.001).
  • Bowel diary showed decrease in FI episodes, baseline 8.4 (±8.73) to 10 weeks 4.8 (±3.79), (p = 0.052).
• Study Title: Multicenter Randomized Controlled Trial of Pelvic Floor Muscle Training with a Motion-based Digital Therapeutic Device versus Pelvic Floor Muscle Training Alone for Treatment of Stress-predominant Urinary Incontinence 2021
  Study Design: Randomized Controlled Trial; IRB approved
  Outcomes: Participants in the intervention group of the first RCT experienced 70% fewer SUI episodes from baseline to week 8, improvement that was statistically significant compared to the control group. Only participants in the intervention group demonstrated statistically and clinically significant symptom improvement as early as 4 weeks, suggesting faster results than the control group. An adequately powered RCT was subsequently executed and published in March 2022.​
• Study Title: Evaluation of an accelerometer-based digital health system for the treatment of female urinary incontinence: A pilot study 2019
  Study Design: Single-arm trial; IRB approved
  Outcomes: Pilot testing of this accelerometer-based system demonstrates improvements in objective PFM measures, patient-reported UI severity and condition-specific quality of life, with results evident after 1 week of use.