A digital intravaginal device for pelvic floor muscle training improved urinary incontinence symptoms and reduced the number of episodes compared with a home training program, according to findings from a randomized controlled study.
“Pelvic floor muscle exercises, or Kegel exercises, are recognized as first-line treatment option for the three major types of urinary incontinence: stress, mixed and urgency incontinence,” Milena M. Weinstein, MD, associate professor of gynecology and reproductive biology at Harvard Medical School, told Healio. “Women are usually advised to do this at home on their own, but women who should be doing them to treat their urinary incontinence struggle to do so successfully. The pelvic floor muscles cannot be seen — they are inside the bony pelvis — and there is no immediate feedback about whether a woman is performing them correctly. There have been many in-office feedback options, like pelvic floor physical therapy or pressure-related feedback, but none of them worked well.”
Establishing the study cohort, methods
Weinstein, who is also co-chair of the center for pelvic floor disorders and program director of the female pelvic medicine and reconstructive surgery fellowship at Massachusetts General Hospital, and colleagues randomly assigned 299 women with stress-related urinary incontinence to an intervention with the leva Pelvic Health System (Renovia) — a motion-based digital therapeutic device (n = 143) — or to a home training program with written and narrated guidance (n = 156).
Women were screened for eligibility from September 2020 to March 2021. Due to COVID-19 restrictions, the study was conducted entirely remotely, and all materials were mailed to the participants.
From baseline to 8 weeks, the researchers measured symptom improvement using the 6-item Urogenital Distress Inventory (UDI-6) and had participants record stress urinary incontinence (SUI) episodes in a 3-day bladder diary. Additionally, participants completed quality-of-life questionnaires and self-reported treatment adherence.
Significant improvement with intervention
The results of the trial, published in Obstetrics & Gynecology, showed that both groups had improved UDI-6 scores. However, the mean improvement was significantly greater in the intervention group compared with the control group from baseline to 4 weeks (15.3 vs. 12.1; P = .026), from 4 to 8 weeks (13.2 vs. 8.9; P < .001) and from baseline to 8 weeks (18.8 vs. 14.7; P= .011).
Bladder diary records showed there were significantly fewer SUI episodes in the intervention group compared with the control group, and more intervention participants had a 50% or greater reduction in SUI episodes (OR = 1.7; 95% CI, 1.03-2.81).
A significantly greater number of women in the intervention group reported they were “much improved” or “very much improved” on the Patient Global Impression of Improvement than in the control group (44.1% vs. 28.8%; OR = 1.9; 94% CI, 1.2-3.2). There were no significant differences between groups for other quality-of-life questionnaires.
Self-reported adherence over the study was 84% in the intervention group and 89% in the control group. The device-reported adherence in the intervention group was 69%; 78.5% of participants reported a higher adherence than the device did.
“Digital therapeutics — when proven to be as effective as in our study — are an amazing option for women with urinary incontinence,” Weinstein said. “They can treat their urinary incontinence in the privacy of their own home, while still being cared for by their health care provider. In the case of leva, the prescriber gets a monthly report about the patient’s participation in the exercise regimen, as well as information about symptom change using a validated survey.”
Weinstein and colleagues wrote that their findings may be affected by COVID-19 restrictions, since quality-of-life surveys included questions on the impact urinary incontinence had on activities such as attending movies and traveling.
Moving forward, Weinstein said research is needed on how the leva device could help postpartum women.
“Postpartum women are a unique patient population not directly addressed in this study,” Weinstein said. “While I feel certain that this device could help women who have postpartum urinary incontinence, we plan to do a study that focuses on this patient group.”
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