FDA authorizes study exploring novel device for bladder incontinence

The FDA has approved the launch of an investigational device exemption trial exploring a novel implantable tibial neuromodulation (TNM) device designed to relieve symptoms of bladder incontinence.¹

The trial, known as the TITAN 1 Feasibility Study, is a multicenter, prospective trial aiming to enroll 20 patients at 8 clinical sites in the United States. The patients will have the device implanted in the posterior tibial nerve near the ankle. They will be followed for 12 months to assess the feasibility of the product. Enrollment for the trial is expected to commence in May.

Medtronic currently offers several products for bladder control, including the InterStim sacral neuromodulation systems and the NURO percutaneous tibial neuromodulation (PTNM).

"Our goal is to stay at the forefront of therapy innovation, and we believe implantable TNM is an important part of the future of therapy for bladder incontinence," Brett Wall, executive vice president and president of the Neuroscience Portfolio at Medtronic, stated in a press release. "We remain completely committed to our sacral neuromodulation portfolio because this option is, and will continue to be, the best choice for many patients. Implantable TNM aims to be an extension of our belief that choice matters. No 2 patients are the same and their therapy should not be either."

Tibial neuromodulation efficacy

Previously published data assessing the NURO device established the efficacy of Medtronic’s PTNM technology. The RESET study assessed PTNM with the NURO system in 120 drug-naïve patients with overactive bladder.²

The patients received 12 weekly sessions with the NURO system. Bladder diaries were used to evaluate changes in voiding symptoms from baseline through 12 weeks. The investigators assessed safety by examining adverse events (AEs) related to the device, procedure, and the therapy itself.

Baseline characteristics showed a mean patient age of 64.8 years and a mean duration of OAB at diagnosis of 3.4 years. Overall, 86% of patients were female and no patients had received medication to treat OAB prior to enrolling in the study. The mean number of daily urge urinary incontinence (UUI) episodes at baseline was 3.5 ± 2.5 (mean ± SD).

At each follow-up visit, the NURO device led to a significant improvement in UUI episodes from baseline. After session 12 from baseline, the reduction was 2.4 ± 2.1 episodes. Further, subjects with urinary frequency had a mean urinary frequency at baseline of 11.5 ± 2.9 voids/day and had a significant reduction of 1.7 ± 2.5 voids/day observed after session 12.

The investigators did not observe any serious or unexpected AEs. The most frequently occurring AEs were medical device site pain (3.3%) and extremity pain (3.3%).

References

1. Medtronic Receives FDA Approval to Launch Clinical Study for Implantable Tibial Neuromodulation Therapy for Bladder Incontinence. Published online April 27, 2021. Accessed April 27, 2021.

2. Kobashi K, Nitti V, Margolis E, et al. A prospective study to evaluate efficacy using the NURO percutaneous tibial neuromodulation system in drug-naïve patients with overactive bladder syndrome. Urology. 2019;131:77-82. doi: 10.1016/j.urology.2019.06.002