Medtronic recently announced the first patients have been implanted in the TITAN 2 pivotal study—which will evaluate the safety and efficacy of its investigational tibial neuromodulation (TNM) device in people with overactive bladder (OAB). The minimally invasive, implantable technology stimulates the posterior tibial nerve near the ankle, transmitting electrical impulses that regulate neural activity of the bladder.
“Implantable TNM has the potential to offer relief to millions who suffer from bladder incontinence through a new approach that will provide greater convenience and more options for physicians and patients,” said Una Lee (Virginia Mason Medical Center, Seattle, USA), national principal investigator for TITAN 2. “The first patient implants in the TITAN 2 study marks the beginning of what may be an important part of the future for better bladder control.”
Medtronic currently offers percutaneous tibial neuromodulation (PTNM) therapy through its Nuro system to the millions of Americans living with OAB today—but PTNM requires patients to visit a clinic setting to receive therapy, and return for repeat treatments, according to the company. As such, an implantable TNM device would reduce the burden on patients and physicians by delivering ongoing treatments without the need for additional clinic visits. The procedure is also less invasive than sacral neuromodulation, the current standard of care.
The TITAN 2 study is a prospective, multicentre, pivotal study intended to examine the safety and efficacy of Medtronic’s implantable TNM device in people with OAB. The study will include up to 130 patients from up to 30 sites in the USA. The primary endpoint for the study will be assessed at six months, and patients will be followed for 24 months in total.
Launched in April 2021, the TITAN 1 feasibility study characterised the procedure for the implantable TNM device in subjects with bladder incontinence, according to Medtronic. Upon successful completion of TITAN 2, the company will prepare its submission to the US Food and Drug Administration (FDA) for approval of the device for this indication.