Keith Xavier, MD, highlights UUI outcomes with ITNM across care settings

At the 2026 American Urological Association (AUA) Annual Meeting in Washington, DC, investigators presented a 24-month analysis from the TITAN 2 trial showing that outcomes with the Medtronic implantable tibial neuromodulation (ITNM) system were not statistically different across physician offices, ambulatory surgical centers (ASCs), and hospital outpatient departments (HODs), supporting the therapy’s flexibility across different care settings.¹ Lead author Keith Xavier, MD, URPS, of Urology Partners of North Texas, sat down with Urology Times^® at the meeting to discuss the study and its findings.

TITAN 2 is a prospective, multicenter, single-arm pivotal investigational device exemption study evaluating the safety and efficacy of the Medtronic ITNM system in patients with urge urinary incontinence (UUI). The study enrolled 126 patients, the majority (95%) of whom were women, with a mean age of 63 years. Earlier findings from TITAN 2 demonstrated meaningful reductions in UUI episodes, with most patients achieving greater than 50% improvement in symptoms. Previous analyses also showed improvements in urinary frequency and acceptable safety outcomes that were comparable to those observed with other implantable tibial nerve therapies, according to Xavier.

The analysis presented at AUA 2026 focused specifically on whether site of service influenced long-term outcomes. Implant procedures were distributed relatively evenly across physician offices (36.5%), ASCs (34.9%), and HODs (28.6%). Investigators evaluated changes in UUI episodes, Patient Global Impression of Improvement (PGI-I) scores, and Overactive Bladder Questionnaire (OAB-q) quality-of-life measures through 24 months.

Xavier noted that all efficacy and quality-of-life outcomes were statistically similar regardless of where the procedure was performed. No significant differences were observed between physician offices, ASCs, or HODs at either 12 or 24 months, suggesting that the effectiveness of the ITNM system remains stable across practice environments.

Safety findings were also consistent across sites of service. Rates of adverse device effects were similar at all evaluated time points through 24 months (P = .84), and all events were mild or moderate in severity, commonly involving infection or pain. Investigators reported 1 serious adverse event—a resolved C. difficile infection in an HOD patient. Xavier emphasized that although the primary purpose of the analysis was not to compare procedural settings, the findings support the feasibility of offering implantable tibial neuromodulation across multiple care environments without compromising efficacy or safety.

REFERENCE

1. Xavier K, Lee U, Carey J, et al. ANALYSIS OF SITE OF SERVICE ON THE SAFETY AND EFFECTIVENESS OF A MEDTRONIC IMPLANTABLE TIBIAL NEUROMODULATION DEVICE IN THE TITAN 2 STUDY. J Urol. 2026;215(5S):e1348. doi:10.1097/01.JU.0001191684.24295.39.14