- This randomized, controlled trial involved 143 women who used a motion-based digital device to guide pelvic floor muscle training (PFMT) and 156 who performed standard PFMT to treat stress urinary incontinence for eight weeks
- Improvement on the Urogenital Distress Inventory, Short Form (UDI-6) was statistically significant in both groups by week 4, but the intervention arm was significantly more improved than the control group at both weeks 4 and 8
- The intervention group met or exceeded the minimum clinically important difference on the UDI-6 at both weeks 4 and 8; the control group met it at week 4 and not at week 8
- The median number of stress urinary incontinence episodes improved significantly in both groups, but the improvement was significantly greater in the intervention group
- No device-related serious adverse events were noted in either treatment arm; urinary tract infections were reported by 1.1% of the intervention group and 1.7% of the control group, and vaginal irritation by 2.7% and 0.55%, respectively
Level I evidence supports pelvic floor muscle training (PFMT) for the treatment of urinary incontinence (UI), but the results are usually suboptimal. Few clinicians, such as pelvic floor physical therapists and continence nurse specialists, are available to teach patients how to do the exercises and ensure they continue performing them correctly.
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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 recently published promising but inconclusive efficacy data from a randomized, controlled trial of a motion-based digital device that guides home PFMT. Those data appeared in Female Pelvic Medicine & Reconstructive Surgery.
Now, based on the results of a fully powered trial, Dr. Weinstein and colleagues conclude the use of the leva Pelvic Health System is associated with a greater reduction in stress UI episodes and burden than PFMT based on written and verbal instructions. Their new report appears in Obstetrics & Gynecology.
About the Device
The leva device is a flexible vaginal insert that communicates wirelessly with a smartphone app. The insert uses accelerometers to detect correct or incorrect pelvic floor motion, which is represented by a dial on the smartphone screen. These data are cloud-captured and relayed to the prescribing clinician, which was done in this study.
The study was conducted virtually because of the COVID-19 pandemic. Women were recruited on U.S. social media from October 2020 through March 2021 and were eligible if they reported at least a three-month history of stress UI or stress-predominant mixed UI.
363 participants were randomly assigned and 299 had data available for analysis:
- Intervention group (n=143)—received the device and written instructions in the mail, and followed in-app instructions for setup and training
- Control group (n=156)—received written instructions and video training (on a USB drive) in the mail
Both groups were asked to do a set of exercises three times daily for eight weeks. Study staff scheduled three scripted phone calls with participants to help ensure they were following instructions.
Co-primary Outcome: UDI-6
Mean score on the Urogenital Distress Inventory, Short Form (UDI-6) improved significantly from baseline to week 8 in both groups:
- Intervention—from 54.6 to 42.8 (P<0.001)
- Control—from 52.9 to 36.3 (P<0.001)
The between-group difference in change was 35% (18.8 vs. 14.7; P=0.01). Both groups also improved significantly by week 4, but the intervention group improved significantly more.
UDI-6 scores were converted to UDI scores (long form) to determine whether the minimum clinically important difference (MCID) on the UDI, 11 points, was met for each group. The intervention group met or exceeded the MCID at both week 4 and week 8; the control group met it at week 4, but not week 8.
Co-primary Outcome: Bladder Diaries
The median number of stress UI episodes on the three-day bladder diary improved significantly from baseline to week 8 in both groups:
- Intervention—from 5 to 1 (P<0.001)
- Control—from 5 to 2 (P<0.001)
The between-group difference was statistically significant (P=0.005). The intervention group was also more likely to report a ≥50% reduction in episodes (OR, 1.7; 95% CI, 1.03–2.81).
Safety was analyzed for all 363 participants (intervention, n=182; control, n=181). No device-related serious adverse events were noted. Urinary tract infections were reported by 1.1% of the intervention group and 1.7% of the control group, and vaginal irritation was reported by 2.7% and 0.55%, respectively.
The commercial version of the leva system offers new opportunities for obstetrician-gynecologists to engage with patients via audiovisual evidence-based education, remote coaching, and monthly patient progress reports. Those components were removed for this trial and will be investigated in future research.
Work is also underway to understand whether patients should do maintenance exercises to retain the benefits of the leva-guided PFMT treatment regimen.
Learn more about the Center for Pelvic Floor Disorders
Refer a patient to the Department of Urology