Novel device improves quality of life in women with urinary incontinence

Key takeaways:

• The device significantly improved quality of life and symptoms among women with urgency urinary incontinence over 24 months.
• Participants who did not achieve the trial’s efficacy endpoint still benefitted.

An implantable tibial neuromodulation treatment significantly improved quality of life among women with urgency urinary incontinence, according to a study presented at the American Urological Association Annual Meeting.

Also published in The Journal of Urology, the study showed the benefits associated with the novel implantable tibial neuromodulation system, known as Revi, were sustained throughout 24 months in women with urgency urinary incontinence (UUI).

“Revi provides a highly effective, sustainable and well-tolerated treatment option for patients with UUI who are living with disruptions to their quality of life,” Roger R. Dmochowski, MD, MMHC, a professor of urology and surgery at Vanderbilt University Medical Center and chief medical officer at BlueWind Medical, told Healio.

Revi is “a small device implanted near the tibial nerve in the ankle in one outpatient procedure,” Dmochowski said. “Patients wear an external, battery-operated device that activates the implant for approximately 30 minutes per day, stimulating the nerve to help control bladder function.”

According to the Cleveland Clinic, people with UUI have a sudden urge to urinate — sometimes resulting in accidental leakage — that occurs several times during the day and night.

In the Overactive Bladder Stimulation System Study (OASIS), the efficacy and safety of Revi was assessed among 151 women with UUI through voiding diaries and quality-of-life questionnaires, the latter of which were collected at 6, 12 and 24 months after the device was implanted.

The treatment’s response rate — the trial’s efficacy endpoint, which was defined as a 50% or greater decrease in UUI episodes — was 77.8% at 6 months, 82% at 9 months and 79.4% at 24 months.

The researchers found that Revi was tied to significant and sustained improvements in all the domains of the Overactive Bladder Questionnaire, including coping, sleep, social and concern.

There was a nearly 40-point reduction in symptom severity score during the study, decreasing from 70.3 at baseline to 31.5 at 24 months.

Meanwhile, 87.2% of participants reported a 10-point or greater improvement in the total transformed Health-Related Quality of Life score at 24 months.

At that point in time, most participants reported treatment benefit (96.8%) and treatment satisfaction (96.7%).

Dmochowski and colleagues reported that the 21% of patients who did not meet the efficacy endpoint at 24 months still showed appreciation of Revi, with:

• 83.3% acknowledging treatment benefit;
• 66.7% reporting treatment satisfaction; and
• 100% reporting a willingness to continue.

Dmochowski said that Revi “is especially suited for the large ‘watchful waiting’ population — those living with untreated or inadequately managed UUI.”

“It offers a minimally invasive, highly customizable solution without an implanted battery,” he said.

Dmochowski concluded that the device “enables early intervention without requiring step-therapy failures and offers a non-drug, durable solution that substantially improves quality of life across critical domains like sleep, social function and emotional well-being.”

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For more information:

Roger R. Dmochowski, MD, MMHC, can be reached at primarycare@helio.com.