- This multicenter, randomized, controlled trial compared outcomes in women with stress-predominant urinary incontinence who used (n=29) or did not use (n=32) a motion-based intravaginal digital device to guide pelvic floor muscle training
- There was no difference between the intervention and control groups on the primary outcome measures, Patient Global Impression of Improvement and Urinary Distress Inventory-6
- The median number of urinary incontinence episodes reported on a three-day bladder diary decreased significantly more in the intervention group than in the control group (-1.7 vs. -0.7 per day; P=0.047)
- Average scores improved significantly more in the intervention group on the Colorectal–Anal Distress Inventory-8 (-8.9 vs. -2.2; P=0.04) and Pelvic Floor Impact Questionnaire-7 (-9.2 vs. -3.7; P=0.02)
- The trial was underpowered; it was terminated early when technical difficulties arose with the device, and a larger trial is underway with an updated device
Pelvic floor muscle training (PFMT) is the first-line treatment for women with stress urinary incontinence, but cure rates are low. There's no consensus about the optimal number of repetitions or optimal duration of therapy, and even among women motivated enough to adhere for months or years, many perform the training incorrectly.
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Electromyographic- and pressure-mediated biofeedback devices are available to guide correct performance, but their use has not been shown to be superior to PFMT alone in treating urinary incontinence.
Now, Milena M. Weinstein, MD a specialist in the Female Pelvic Medicine and Reconstructive Surgery Program in the Department of Obstetrics and Gynecology at Massachusetts General Hospital, and colleagues have observed benefits from a motion-based digital training device for PFMT. They published details in Female Pelvic Medicine & Reconstructive Surgery.
Background on the Device
leva (Renovia, Inc.) is an FDA-approved intravaginal pelvic floor muscle trainer with visualization technology. Sensors along the vaginal insert measure the motion of the pelvic floor muscle and communicate wirelessly with a smartphone application that gives the user visual feedback. This allows women to differentiate between a lift and squeeze and a Valsalva maneuver or other incorrect motion.
At seven sites, women with stress-predominant urinary incontinence were recruited between October 2018 and September 2019. They were randomly assigned to:
- The intervention group—PFMT using the device. After a training session, participants were asked to perform the exercises twice per day, for 2.5 minutes per session, for eight weeks
- The control group—PFMT alone. Participants received standardized written and verbal instructions and were asked to perform the exercises three times per day, with 10 repetitions per set, for eight weeks
Before and after the study period, participants completed a battery of questionnaires and kept a three-day bladder diary.
Enrollment was terminated early when technical difficulties arose with the device. The researchers decided to report on trial accrual to date (intervention, n=29; control, n=32).
Benefit on the Patient Global Impression of Improvement was defined as a response of "much better" or "very much better." There was no difference between the intervention and control groups in improvement at week 8.
Similarly, there was no significant difference at week 8 in improvement on the Urinary Distress Inventory-6 (UDI-6).
Some measures did show differences between the two study arms:
- Both groups reached the minimum important difference on the UDI-6 by week 8 (score of 11), but only the intervention group reached it by week 4
- The median number of urinary incontinence episodes reported on the bladder diary decreased significantly more in the intervention group than in the control group (−1.7 vs. −0.7 per day; P=0.047)
- Average scores improved significantly more in the intervention group on the Colorectal–Anal Distress Inventory-8 (−8.9 vs. −2.2; P=0.04) and Pelvic Floor Impact Questionnaire-7 (−9.2 vs. −3.7; P=0.02)
The Research Continues
This underpowered study did not meet its primary endpoints, but the use of the digital trainer resulted in fewer episodes of incontinence and improved quality of life compared with PFMT alone. The researchers have a larger trial underway with an updated device.
Learn more about the Female Pelvic Medicine and Reconstructive Surgery Program
Refer a patient to the Department of Obstetrics and Gynecology