RENOVA iStim System shows safety in refractory overactive bladder

The investigators report that no device or procedure-related serious adverse events have occurred.

The BlueWind RENOVA iStim System demonstrated safety in a cohort of 151 patients undergoing treatment for refractory overactive bladder.

Results from the OASIS trial, a prospective, interventional, multicenter, single-arm, open-label study were presented by senior author John Heesakkers, MD, PhD, of Radboud University Medical Centre in Njimegen, the Netherlands.

The study enrolled women with urgency incontinence. Patients had to have at least 1 urinary urgency incontinent episode per day for 5 days. Mean age was 58.9 years.

“The device is implanted in the lower leg during a minimally invasive procedure in which it is secured superficial to the tibial neurovascular bundle, just below the fascia. The implant is activated [approximately] 4 weeks after implantation,” wrote the authors. Patients are instructed to apply the wearable unit and then preform daily stimulation treatments at home for a period of 30 to 120 minutes per day. The investigators collected voiding diary data, quality of life questionnaires, and patient satisfaction questionnaires at 6, 12, 24, and 36 months after device activation and compared these data with baseline. Primary end points were efficacy, which was defined as patients having at least a 505% reduction in urgency urinary incontinence episodes at 6 months, and safety, characterized as incidence of device and procedure-related adverse events at 12 months post activation.

A total of 151 subjects have undergone implantation in 9 centers in Europe and 14 in the US. Mean baseline of 4.72 UUI per day and 10 voids per day were reported. Of the cohort, 151 patients have 6 months’ follow-up and 76 have 12 months’ follow-up. The investigators report that no device or procedure-related serious adverse events have occurred. A total of 144 patients had adverse events that were adjudicated, of which 7 (4.8%) had mild and 4 (2.8%) had moderate device or procedure AEs.

In his concluding remarks, Heesakkers said the RENOVA iStim offers single-stage therapy and a battery- and recharge-free implantable component.

Reference

1. Sutherland S, Padron O, Benson K, et al. OASIS pivotal trial to evaluate the safety and efficacy of the RENOVA iStim system for the treatment of women with OAB. J Urol. 2022;207(5S):e1043.doi:10.1097/JU.0000000000002670.05