Implantable Tibial Neuromodulation Therapy Improves Symptoms of Urge Urinary Incontinence From the TITAN 2 Pivotal Study
Year: 2026
Type: article
Study design: Clinical Trial
Abstract: 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.
Source: The Journal of Urology
Authors: Una Lee, Keith Xavier, Jeffrey Carey, Alison Pickering, Janet Harris-Hicks, Laura Giusto, Kenneth Finkelstein, Jason Kim, Jerome Yaklic, Emily Gillespie, Nathan Grunow, Kevin Benson, Hadley Narins, Scott MacDiarmid, Ryan Krlin, Kimberly Burgess, Courtenay Moore, Geoffrey Towers, Dennis Miller, Nicolette Deveneau, Melissa Fischer, Brian Linder, Elizabeth Takacs, Annah Vollstedt, Humphrey Atiemo, Samantha Raffee, Jodi Michaels, Jason Bennett, Stephanie Kielb, Amanda Vo, Jeffrey Proctor
Language: English
Subfield: Urology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,000
OpenAlex ID: W7125713909