Efficacy of Transcutaneous Tibial Nerve Stimulation With Silver Spike Point® Electrodes for Refractory Overactive Bladder: A Single-Arm Study.

Background Tibial nerve stimulation therapy is a treatment option for an overactive bladder. A surface electrode called a Silver Spike Point® electrode, which does not directly puncture the skin as in transcutaneous tibial nerve stimulation, but is expected to exert the same therapeutic effect as percutaneous tibial nerve stimulation, was developed. This study investigated the efficacy and safety of tibial nerve stimulation with Silver Spike Point® electrodes for refractory overactive bladder. Methodology This was a six-week, single-arm, prospective study on the efficacy and safety of transcutaneous tibial nerve stimulation for patients with refractory overactive bladder. Each treatment lasted 30 minutes and was performed twice a week. The stimulation sites of the tibial nerve were the Sanyinjiao point (SP6) and Zhaohai point (KI6) in both legs. The primary endpoint was the change in the total overactive bladder symptom score. Results In total, 29 patients (20 males and nine females: 64.86 ± 17.98 years old) were included in this study. Two women dropped out; one because of an adverse event and the other as requested. Therefore, 27 patients completed the study. The total overactive bladder symptom and International Consultation on Incontinence Questionnaire-Short Form scores significantly decreased by 2.22 and 2.39 points, respectively (p < 0.01 each). In the frequency volume chart, the numbers of urgency episodes and leaks in 24 hours significantly decreased by 1.53 and 0.44, respectively (p = 0.02 each). Conclusions Transcutaneous tibial nerve stimulation therapy using Silver Spike Point® electrodes was useful for patients with refractory overactive bladder and, thus, has potential as a new treatment option for refractory overactive bladder.