An implantable tibial neuromodulation (ITNM) therapy results in statistically significant improvements in urge urinary incontinence (UUI), urinary frequency, and urgency symptoms, as shown in the TITAN 2 study. These benefits have been sustained through 12 months, with no serious safety concerns.
“The Medtronic ITNM system is a minimally invasive procedure that implants a small rechargeable device providing at-home stimulation,” the researchers said. “ITNM provides an additional treatment option for the millions of UUI patients, including some who may encounter challenges of access, burden, or invasiveness with other therapies.”
A total of 126 overactive bladder patients with UUI (mean age 63 years, 95 percent female, BMI 35 kg/m2) were enrolled in this prospective, multicentre, single-arm investigational device exemption study. The percentage of participants with ≥50-percent reduction in UUI episodes/day after 6 months was the primary endpoint. Safety was assessed through the rate of adverse device effects (ADEs).
More than half (59 percent) of the participants achieved the primary endpoint (95 percent confidence interval, 49‒67; p<0.0001) at 6 months. This proportion further increased to 61 percent at 12 months. [J Urol 2026;215:702-712]
At 6 months, statistically significant changes from baseline were noted for UUI episodes/day, voids/day (in urinary frequency participants), and Urgency Perception Score. Furthermore, improvements in all three symptoms persisted up to 12 months.
Safety profile
In terms of safety, one in five participants (20 percent) experienced ADEs through 12 months, with one serious ADE that was also resolved.
“The 20-percent rate of ADEs and 1-percent rate of serious ADEs demonstrates a favourable safety profile,” the researchers said. “The results of this and other ITNM studies demonstrate the safety of this new delivery method for TNM with ADE rates between 10 percent and 20 percent (most mild or moderate).” [J Urol 2021;206:399-408; J Urol 2021;206:399-408]
Some of the common ADEs were pain and incision site/wound-related complications, most of which occurred during the first few months of implantation.
These rates are similar to those reported for percutaneous TNM (5 percent to 28 percent), “supporting an implantable delivery method involving a single procedure performed under local anaesthesia as a safe alternative for [patients] that find the burden of frequent clinic visits a barrier.” [J Urol 2021;206:399-408; J Urol 2010;183:1438-1443; Int Urol Nephrol 2021;53:2459-2467]
“[Participants] demonstrated clinically meaningful improvement in quality of life and positive patient-reported outcomes,” the researchers said. “Benefits were observed after 6 months and maintained through 12 months, with a favourable safety profile.”
Limitations
This study was limited by the lack of blinding and sham control. The TITAN 2 methods paper presented detailed consideration and challenges with designing a sham-controlled study, according to the researchers, noting that while the current study introduces potential for placebo effect, the consistency of the results through 12 months reduces such concerns.
“While the Medtronic ITNM system offers flexible therapy scheduling, optimal stimulation cadence and parameters are areas for future investigation,” they said.