A closed-loop wearable tibial neuromodulation system for patients with urge urinary incontinence (UUI) and urinary urgency caused by overactive bladder (OAB) shows efficacy at 12 weeks and up to 1 year with acceptable safety, a new study finds.
The non-invasive, FDA-cleared, wearable neuromodulation system allows patients to perform electrical stimulation at home. Avation Medical unveiled its Vivally System at the 2024 conference of the Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction.
In the single-center FREEOAB study, 96 patients (88.5% female) used the transcutaneous tibial neuromodulation system 1 to 3 times weekly. At baseline, mean voids and urge urinary incontinence rates were 13.4 and 4.7 episodes/day, respectively, according to bladder diaries. Some patients had prior medication therapy.
At 12 weeks, 89 patients experienced a significant mean reduction of 2.84 voids from baseline, Colin Goudelocke, MD, of Ochsner Medical Center in New Orleans, Louisiana, and colleagues reported in Urology. Incontinence decreased by a significant 1.91 episodes per day in 76 patients. For 25.8% of patients, frequency normalized to 8 voids or less per day, 23.7% of patients reported no daily leaks, and 25.7% reported no daily urgency episodes at 12 weeks.
According to OAB-q questionnaire responses, quality of life scores related to coping, concern/worry, sleep, and social interaction all improved and exceeded the minimal clinically important difference threshold.
The 39 patients who continued the trial to 12 months experienced a mean decrease of 1.85 voids and 1.29 UUI episodes per day, the investigators reported. By that point, therapy was performed twice a month.
Among 12 device-related adverse events, none were severe. Patient compliance and satisfaction rates appeared high.
“Wearable tibial neuromodulation has garnered interest as a noninvasive, patient-centered alternative to existing therapies, expanding treatment options and access to care,” according to the investigators.
Disclosure: This research was supported by Avation. Please see the original reference for a full list of disclosures.
References:
Goudelocke C, Sobol J, Poulos D, Enemchukwu E, Zaslau S, Dhir R. A multicenter study evaluating the frequency of use and efficacy of a novel closed-loop wearable tibial neuromodulation system for overactive bladder and urgency urinary incontinence (FREEOAB). Urol. 2024 Jan;183:63-69. doi:10.1016/j.urology.2023.10.007