Una Lee, Keith Xavier, Jeffrey M. Carey, Alison Pickering, Janet E. Harris-Hicks, Laura Giusto, K. D. Finkelstein, Jason Kim, Jerome L. Yaklic, Emily Gillespie, Nathan Grunow, Kevin Benson, Hadley Narins, Scott MacDiarmid, Ryan M. Krlin, Kimberly Burgess, Courtenay Moore, Geoffrey D. Towers, Dennis Miller, Nicolette Deveneau, M Fischer, Brian J. Linder, Elizabeth Takacs, Annah Vollstedt, Humphrey Atiemo, Samantha Raffee, Jodi Michaels, Jason Bennett, Stephanie Kielb, Amanda Vo, Jeffrey Proctor
PURPOSE: The Medtronic implantable tibial neuromodulation 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 (ADEs). Data are reported as mean ± SD or with 95% CIs. RESULTS: < .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, 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.