Overactive bladder (OAB) patients who undergo sacral neuromodulation therapy with the InterStim System have a 30% rate of reported device-related adverse events (AEs) after 1 year, but most are minor, according to the findings of prospective InSite trial.
In the trial, which included 272 patients with OAB treated with sacral neuromodulation, only 1 patient experienced an AE that was considered serious.
The primary aim of the study, which was led by Karen Noblett, MD, of the University of California Riverside, was to provide a detailed analysis of the AEs and surgical intervention out to 12 months.
Of the 272 patients, 82 (30%) reported device-related AEs. Fifty-six percent of device-related AEs occurred between implant and 3 months, Dr Noblett’s group reported in Neurourology and Urodynamics. The most frequent device-related AEs were an undesirable change in stimulation, which occurred in 32 patients (12%); implant site pain, which occurred in 20 patients (7%); and implant site infection, which occurred in 9 patients (3%). The overall surgical intervention rate was 13%, with pain at the surgical site, lack/loss of efficacy, and infection being the most common reasons, the investigators reported.
Dr Noblett’s team noted that the AEs and surgical intervention rates in their study are much lower than those found in earlier trials. Overall rates of AEs and the rates of infection, implant site pain, and surgical intervention were much lower that the rates observed in the MDT-103 pivotal trial (30% vs 52%; 3% vs 6.1%; 7% vs 15.3; and 13% vs 54% respectively), Dr Noblett and her colleagues reported.
“These data suggest that the new techniques and devices related to this therapy have substantially reduced overall AEs and most importantly reduced AEs that lead to more intensive interventions,” the investigators concluded. “These data also give insight into how we may reduce device-related AEs and gives a realistic basis for counseling patients on the risks associated with this therapy.”