Digital Therapeutic That Guides Pelvic Floor Muscle Training Demonstrates Real-World Effectiveness

The leva Pelvic Health System (Renovia, Boston, MA) is a prescription device that visually guides women about how to do pelvic floor muscle training (PFMT). A vaginal insert lined with motion sensors detects movement during the exercises and communicates with a smartphone app to provide real-time feedback to the user.

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A randomized controlled trial established the device's efficacy, and the FDA approved it for treating stress, mixed and mild, to moderate urinary incontinence (UI) in women, including overactive bladder (OAB). It was recently approved to treat chronic fecal incontinence as well.

Milena M. Weinstein, MD, co-director of the Center for Pelvic Floor Disorders in the Department of Obstetrics and Gynecology at Massachusetts General Hospital, and colleagues have published "real-world" data demonstrating the leva system is effective outside a clinical trial for treating UI. Their report appears in the International Urogynecology Journal.

Methods

The team retrospectively reviewed data on 265 women, mean age 51 and mean body mass index 27 kg/m², who began using the leva device to treat UI between July 1, 2020, and December 31, 2021. They regularly completed the Urogenital Distress Inventory Short Form (UDI-6), a validated questionnaire built into the device that assesses the presence and burden of UI symptoms on a scale of 0–100.

Overall Change in UDI-6 Scores

In general, mean UDI-6 scores improved:

• Overall change—From 43.77 points at baseline to 29.87 points at week 8 (P≤0.0001)
• 78% of users reported improvement by week 8
• 11% reported no change
• 11% reported worse symptoms (mean change in score +12.20 points)

When UDI-6 scores were converted to the UDI long form:

• The mean improvement was 26.41 points
• 62% of users met or exceeded the minimum clinically important difference, an improvement of 11 points

Change in UDI-6 Scores by UI Diagnosis

59% of women had stress UI, followed by mixed UI (22%), urgency UI/OAB (11%), and unspecified UI (8%).

Women in each diagnosis category reported significant improvement (P<0.0001 for all). The absolute improvement was:

• Stress UI—14.14 points
• Mixed UI—13.03 points
• Urgency UI/OAB—16.28 points

Adherence

The leva device records adherence to PFMT, with 14 uses/week representing 100%. In this study, the cumulative adherence was 72% at four weeks and 66% at eight weeks.

When the researchers categorized adherence as low (<5 uses/week), medium (5–9 uses/week), or high (≥10 uses/week), significant improvement in UDI-6 score was seen in all three categories. There was no association between improvement in score and adherence category, age, body mass index, or UI subtype.

Adverse Events

4.5% of women reported adverse events:

• Pelvic cramping—1.4%
• Low back pain—0.5%
• Urinary tract infection—0.5%
• Skin irritation—0.5%

There were no severe adverse events.

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