Implantable Tibial Neuromodulation Therapy Improves Symptoms of Urge Urinary Incontinence from the TITAN 2 Pivotal Study.

Abstract

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. 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). 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%, <i>P</i> < .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. 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.