Digital Therapeutic Paired with Device Boosts Pelvic Floor Muscle Training Results for Urinary Incontinence

The digital therapeutic is being marketed as an alternative to specialist-guided therapy or at-home exercises.

A motion-based digital therapeutic device can help alleviate symptoms in women with stress-based urinary incontinence better than at-home training with written and narrated instructions, according to a new study

In a side-by-side comparison, the device, marketed by Renovia under the brand name leva, led to a larger improvement in Urogenital Disease Stress Inventory short-form (UDI-6) scores, compared to the more traditional method. The results of the study, which was funded by Renovia, were published last month in the journal Obstetrics & Gynecology.

Corresponding author Milena Weinstein, M.D., of Massachusetts General Hospital, and colleagues, explained that as many as half of women experience urinary incontinence at some point in their lives, with rates increasing as women age. One treatment is pelvic floor muscle training, a noninvasive regimen that can help strengthen the pelvic muscles to prevent urine leakage and bowel-control problems. The treatment is typically the first-line therapy for stress urinary incontinence, urgency incontinence and mixed-type incontinence, they explained.

The trouble, Weinstein and colleagues said, is that uptake and adherence to the therapy is often lacking, due to a number of barriers.

“These include limited patient knowledge about how to perform pelvic floor muscle training and limited access to care owing to a deficit of skilled professionals (i.e., physical therapists, continence nurse specialists),” they wrote.

Without access to skilled professionals, some women begin a training regimen without supervision, though such unsupervised training is often unsuccessful. Weinstein and colleagues said technology may be able to help fill the gap by not only providing instruction to women on how to do the exercises, but also by providing feedback to verify that they are doing it correctly and regularly.

In the case of leva, the device comes in the form of a small, flexible vaginal insert that uses accelerometers to monitor the contraction of pelvic floor muscles. Those data are then communicated with the patient’s smartphone app to track adherence.

In the study, 363 patients with stress or stress-predominant mixed urinary incontinence were randomized into one of two groups. A group of 182 patients were assigned the intervention group. They were asked to use the leva device for eight weeks. A control group of 181 patients was assigned a home training program using written and narrated instructions over the same time period. The primary outcome was change in UDI-6 scores and number of stress urinary incontinence episodes over the course of a three-day bladder diary.

After eight weeks, the investigators found that patients in the device group had a larger change in UDI-6 score compared to those using written instructions (18.8 points versus 14.7 points). At the same time, the three-day bladder diaries showed patients in the device group went from a median of five stress urinary incontinence episodes over three days to just one, while those in the self-guided cohort went from five episodes down to two.

Weinstein and colleagues noted that the device group had clinically meaningful improvements at both four weeks and eight weeks, while the control group only met the benchmark for clinically important improvement at fourweeks. The authors suggested this might have to do with positive associations driving momentum.

“Early and continued symptom improvement may enhance patient self-efficacy regarding pelvic floor muscle training and positively influence adherence to treatment over time,” they wrote.

That positive attitude toward the regimen might also explain another finding of the study, that patients overestimated their adherence to their regimens. The authors found patients frequently reported higher rates of usage than was accurate, a finding that was enabled by the availability of usage data from the app.

“This finding underscores the challenges in self-reporting and renders the validity of self-reported adherence questionable,” they noted.

In addition to adherence, another secondary outcome was patients’ perceptions of improvements. In this case, patients who used the device were more likely than patients in the control group to say their symptoms were “much improved” or “very much improved.”

Weinstein and colleagues said further research is currently underway to better understand how adherence changes over longer periods of time.