A novel leadless, miniature implantable Tibial Nerve Neuromodulation System for the management of overactive bladder complaints

摘要

Background Overactive bladder is a chronic condition affecting lower urinary tract function that has a significant negative impact on QoL. Objective Evaluation of the BlueWind implantable tibial nerve system performance and safety in refractory OAB. Design, Setting, and Participants Intervention A 6‐month multi‐center prospective intervention study. Outcome Measurements and Statistical Analysis Objective assessment was done by voiding diary parameters including voids/day, volume voided/day, urgency assessment, leaking episodes/day, pads used/day, leak severity, and clinical success defined as a ≥50% reduction in the number of leaks/day or number of voids/day or number of episodes with degree of urgency 2 or a return to 8 voids/day on a 3 Day diary. Subjective assessment was based on OAB‐q including HRQL and symptom severity score. Safety was evaluated by adverse event (AE) analysis. Results and Limitations Thirty‐four of the 36 implanted subjects completed the study. One subject withdrew voluntarily and one developed inflammation necessitating removal of the system. In the remaining subjects, 71% experienced clinical success at 6 months. Leaks/day, leak severity, and pad changes/day decreased significantly over time with 27.6% of urge incontinence subjects that became “dry.” Voids/day, degree of urgency, volume/void, pads changed improved significantly. All quality of life aspects (concern, coping, sleep, and social) improved as well as symptom severity scores measured by the OAB‐q. Adverse events included: implant site pain (13.9%), suspected infection (22.2%), and procedural wound complications (8.3%). Conclusions The BlueWind implantable tibial nerve stimulator is a safe, minimally invasive system that affords OAB patients significant improvements. Patient Summary The performance and safety of the BlueWind RENOVA? implantable tibial nerve neuromodulator for OAB was tested. Our preliminary results demonstrate that the system has a low risk safety profile and may be considered an effective treatment option for OAB management.