Efficacy and safety of an implantable tibial neuromodulation system for overactive bladder with urgency urinary incontinence: an open-label, single arm trial.

Purpose: This study aimed to evaluate the safety and efficacy of a domestically developed implantable tibial neuromodulation system (iTNS) in the treatment of overactive bladder (OAB) in patients with urgency urinary incontinence (UUI). Methods: A prospective single-center open-label trial was conducted. A total of 10 participants underwent iTNS device implantation, followed by device activation at 2-4 weeks post-implantation. Follow-up evaluations were performed at 1, 3, and 6 months post-implantation, including 3-day bladder diaries, validated questionnaires, and symptom satisfaction surveys. The primary endpoint was a ≥50% reduction in UUI episodes per day at 6 months. Results: At 6 months, the iTNS system achieved a 90% response rate (9/10 patients), among whom 40% (4/10) attained ≥3 consecutive dry days. A delayed therapeutic onset was observed: a significant reduction in UUI episodes emerged at 3 months (from 3.235 to 0.766 episodes per day) and 6 months (from 3.235 to 0.632 episodes per day). Quality of life was significantly improved at 6 months, as indicated by the changes in validated questionnaires (OAB-Q: 69.5 ± 11.76 to 44.4 ± 12.06; OABSS: 9 ± 1.155 to 6.2 ± 2.394). Additionally, 80% of patients reported satisfaction with their symptoms at the 6-month endpoint. Conclusions: The domestically developed iTNS system is safe and effective for the treatment of UUI in patients with OAB. It exhibits a strong ability to significantly reduce or completely resolve UUI symptoms, with a favorable safety profile.