Evaluation of clinical performance and safety for the rechargeable InterStim Micro device in overactive bladder subjects: 6-month results from the global postmarket ELITE study.
Colin GoudelockeKeith XavierBarry PechaKimberly BurgessMarie-A Perrouin-VerbeRyan KrlinJodi MichaelsSagar ShahBenoît PeyronnetStanley ZaslauMylène ChampsBianca PapiKatie BittnerDean S EltermanVictor NittiPublished in: Neurourology and urodynamics (2023)
These data confirm the safety and clinical performance of the InterStim Micro device for subjects with OAB by demonstrating a significant improvement in OAB-q HRQL score at 3-month. Similar improvements were observed at 6 months in addition to an incidence of adverse events that is comparable to previously reported rates for SNM.