Implantable tibial neuromodulation therapy improves symptoms of urge urinary incontinence from the TITAN 2 pivotal study

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 ITNM system. Results through 12 months are reported.Materials and Methods: – This prospective, multicenter, single-arm investigational device exemption study enrolled eligible OAB subjects with UUI. The primary endpoint 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 ± standard deviation 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/m². The primary objective was met with 59% of subjects achieving ≥50% improvement in UUI episodes/day (95% CI: 49%, 67%, P < 0.0001) 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; one 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, UF and urgency symptoms. Clinical benefits and a favorable safety profile were maintained through 12 months.