A novel wirelessly powered and programmable tibial neurostimulator may help treat overactive bladder (OAB), investigators reported in a late-breaking session at the American Urological Association’s 2023 Scientific Meeting.
In the international OASIS pivotal trial, investigators implanted the device near the tibial nerve beneath the fascia in 151 women from 23 centers. Clinicians set parameters for stimulation (frequency, pulse width amplitude, and polarity) on an individual basis and remotely. Patients performed the stimulation treatments at home for 30 minutes twice daily using the programmed ankle wrap. The implant has no lead or battery.
At baseline, patients had a mean 4.8 urge urinary incontinence (UUI) episodes daily. By 6 and 12 months, 76.4% and 78.4% of patients experienced at least a 50% reduction in UUI, respectively, in an intention to treat analysis, according to John Heesakkers, MD, the primary investigator and chair of Urology at Maastricht UMC, the Netherlands. Among 139 trial completers at the 12-month follow-up visit, 82.0% of patients achieved at least a 50% reduction in UUI episodes, 66.9% achieved at least a 75% reduction, and 50% were dry for at least 3 consecutive days. At 12 months, 91.6% of patients were still compliant with once-daily treatments.
No serious adverse events occurred, said Dr Heesakkers, who also is general secretary of the International Continence Society. Procedure/wound-related adverse events occurred in 10.6% of patients, and device-related adverse events, such as pain, in 4.0%.
At 12 months, 84.6% of the patients reported a 10 or more point improvement in health-related quality of life.
“We think that this implant is good for overactive bladder complaints and safe for patients,” Dr Heesakkers said.
Disclosure: This research was supported by BlueWind Medical. Please see the original reference for a full list of disclosures.
Heesakkers J, Digesu A, Sutherland S, et al. Pivotal study of a novel wirelessly powered, patient tailored programmed, tibial neurostimulator for the treatment of patients with overactive bladder. Presented at AUA 2023, Chicago, Illinois, April 28-May 1. LBA01-05.
Clinical study results of the BlueWind System for patients with overactive bladder featured at the 2023 AUA Annual Meeting. BlueWind; May 1, 2023.