Rationale and design of an implant procedure and pivotal study to evaluate safety and effectiveness of Medtronic's tibial neuromodulation device

Percutaneous tibial neuromodulation is a medical guideline recommended therapy for treating symptoms of overactive bladder. Stimulation is delivered to the tibial nerve via a thin needle placed percutaneously for 30 min once a week for 12-weeks, and monthly thereafter. Studies have shown that this t...

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Published inContemporary clinical trials communications Vol. 35; p. 101198
Main Authors Lee, Una J., Xavier, Keith, Benson, Kevin, Burgess, Kimberly, Harris-Hicks, Janet E., Simon, Robert, Proctor, Jeffrey G, Bittner, Katie C., Stolen, Kira Q, Irwin, Chris P., Offutt, Sarah J., Miller, Anne E., Michaud, Elizabeth M., Falkner, Phillip C., Coetzee, J. Chris
Format Journal Article
LanguageEnglish
Published Elsevier Inc 01.10.2023
Elsevier
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Summary:Percutaneous tibial neuromodulation is a medical guideline recommended therapy for treating symptoms of overactive bladder. Stimulation is delivered to the tibial nerve via a thin needle placed percutaneously for 30 min once a week for 12-weeks, and monthly thereafter. Studies have shown that this therapy can effectively relieve symptoms of overactive bladder; however, the frequent office visits present a barrier to patients and can impact therapy effectiveness. To mitigate the burden of frequent clinic visits, small implantable devices are being developed to deliver tibial neuromodulation. These devices are implanted during a single minimally invasive procedure and deliver stimulation intermittently, similar to percutaneous tibial neuromodulation. Here, we describe the implant procedure and design of a pivotal study evaluating the safety and effectiveness for an implantable tibial neuromodulation device. The Evaluation of Implantable Tibial Neuromodulation (TITAN 2) pivotal study is a prospective, multicenter, investigational device exemption study being conducted at up to 30 sites in the United States and enrolling subjects with symptoms of overactive bladder.
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Present Address: *Southern Shores Urogynecology and Pelvic Reconstructive Surgery, PC, Myrtle Beach, SC, USA.
ISSN:2451-8654
2451-8654
DOI:10.1016/j.conctc.2023.101198