TITAN 2 為一項前瞻性、多中心、單臂關鍵性試驗，評估 Medtronic 植入式脛神經神經調節（ITNM）系統治療急迫性尿失禁（UUI）的安全性與療效。共納入126位患者（95%為女性，平均63歲），6個月時有59%達到每日UUI發作次數減少≥50%的主要終點，12個月時為61%，且UUI發作次數、排尿頻率與急迫感評分均顯著改善並維持一年。整體不良裝置事件發生率為20%，僅1例為嚴重且已恢復，顯示安全性可接受。

本研究證實ITNM作為無導線、微創且可充電之神經調節選項，對難治型UUI具有臨床意義的改善效果。然而，其單臂設計缺乏對照組，且受試者以女性為主，仍需更長期與隨機對照研究以進一步確認療效持久性與適用族群。

Purpose: The Medtronic implantable tibial neuromodulation (ITNM) system is a leadless, rechargeable, minimally invasive option intended to treat the symptoms of urge urinary incontinence (UUI), a common condition that significantly impairs quality of life. TITAN 2 is a pivotal study evaluating safety and effectiveness of the Medtronic implantable tibial neuromodulation system. The results through 12 months are reported.

Materials and Methods: This prospective, multicenter, single-arm investigational device exemption study enrolled eligible overactive bladder subjects with UUI. The primary end point was the percentage of subjects who had 50% reduction in UUI episodes/day after 6 months. Safety was characterized as the rate of adverse device effects (ADE). Data are reported as mean SD or with 95% confidence intervals (CI).

Results: Of 126 implanted subjects, 95% were female, the mean age was 63 14 years, and BMI was 35 9 kg/m 2 . The primary objective was met with 59% of subjects achieving 50% improvement in UUI episodes/day (95% CI: 49%-67%, P < .0001) at 6 months; at 12 months, 61% had 50% improvement. Change from baseline was statistically significant at 6 months for UUI episodes/day, voids/day (in urinary frequency subjects), and Urgency Perception Score (UPS), with improvements in all 3 symptoms maintained through 12 months. Twenty percent of subjects experienced ADEs through 12 months; 1 ADE was serious and was recovered/resolved.

Conclusions: TITAN 2 met the primary and all secondary objectives by showing a statistically significant improvement of UUI, urinary frequency, and urgency symptoms. Clinical benefits and a favorable safety profile were maintained through 12 months.