Pelvic floor muscle training using a motion-based digital intravaginal device significantly improved symptoms for women with stress urinary incontinence (SUI) compared with a home training program, a virtually conducted randomized controlled trial showed.

Participants who used the device had greater improvements in urinary symptom severity and degree of bother as measured by the Urogenital Distress Inventory, Short Form (UDI-6) score versus the control group (18.8 vs 14.7, P=0.01), reported Milena M. Weinstein, MD, of Massachusetts General Hospital and Harvard Medical School in Boston, and colleagues.

In addition, the median number of SUI episodes on a 3-day bladder diary was reduced from five episodes to one episode in the intervention group and from five episodes to two in the control group (P=0.005), with more participants in the intervention group reporting a ≥50% reduction in SUI episodes (OR 1.7, 95% CI 1.03-2.81), they noted in Obstetrics & Gynecology.

“This study demonstrates efficacy and safety of a motion-based digital therapeutic device to guide pelvic floor muscle training for women with SUI and stress-dominant mixed urinary incontinence, yielding superior results compared with a home program of written and verbal instructions,” Weinstein’s team wrote. “Additionally, the device enables remote monitoring of adherence to pelvic floor muscle training, which offers a new opportunity for obstetrician-gynecologists to monitor and engage with patients during first-line care.”

Of note, a significantly greater proportion of participants in the intervention group reported they were “much improved” or “very much improved” on the Patient Global Impression of Improvement (44.1% vs 28.8% in the control group; OR 1.94, 95% CI 1.21-3.15), the researchers added.

Although pelvic floor muscle training has been a first-line conservative treatment for urinary incontinence, SUI, urgency urinary incontinence, and mixed urinary incontinence subtypes, individual and institutional barriers to uptake have resulted in inadequate adherence to training programs. “In the absence of supervised care, women may embark on an unsupervised pelvic floor muscle training regimen, often with limited efficacy,” they observed.

This trial was designed to evaluate a device composed of a small, flexible vaginal insert. Using accelerometers, the device reflects the motion of the vagina when pelvic floor muscles are contracted, and wirelessly communicates information that is eventually relayed to prescribing healthcare professionals, allowing them to remotely monitor patients.

The study evenly randomized 363 women ages 18 and older with SUI or stress-dominant mixed urinary incontinence symptoms for 3 months or longer to the intervention and control arms, with no significant demographic or clinical differences between groups. Participants’ mean age was about 52, and mean body mass index was 31.7.

Baseline UDI-6 scores were high (greater than 50) in both groups, indicating severe incontinence symptoms and bother. Weinstein and team noted that the UDI-6 score significantly improved in both groups from baseline to 4 weeks and from 4 weeks to 8 weeks. However, while the intervention group met or exceeded the minimum clinically important difference of 11 points at both the 4- and 8-week post-intervention timepoints, the control group met that difference only at the 4-week timepoint.

The researchers pointed out that a strength of the study was its virtual design, which allowed for nationwide recruitment of participants and uninterrupted data collection, despite the COVID-19 pandemic. However, a weakness of the study was the inability to conduct a physical examination of the participants before enrollment.

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