DTx Product Profile

leva®

Product Highlight

Condition targeted:

Urinary incontinence

How it works:

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.

Impact:

The leva® Pelvic Health System treats female urinary incontinence through rehabilitation and training of weak pelvic floor muscles.

Product Overview

Medical conditions:

Urinary incontinence in women.

Target patient population:

Women with urinary 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.

 

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; and 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.

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.

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 physician.

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. 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:

Provider access:

Healthcare providers will be provided monthly summary and individual patient reports that reflect adherence to therapy, symptoms, perceived improvement, and material comments from leva‘s care management team. 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 currently an out-of-pocket expense. It is FSA/HSA-eligible. The company is actively pursuing options for reimbursement to ensure patients have increased access to this product.

Product availability:

leva is available in:

Unique Features

The leva system utilizes patented motion-based feedback and a feature-rich app to promote accessible and effective first line care for female urinary incontinence.

Clinical Trials

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