Rationale and design of an implant procedure and pivotal study to evaluate safety and effectiveness of Medtronic's tibial neuromodulation device by Una J. Lee, Keith Xavier, Kevin Benson, Kimberly Burgess, Janet E. Harris-Hicks, Robert Simon, Jeffrey G Proctor, Katie C. Bittner, Kira Q Stolen, Chris P. Irwin, Sarah J. Offutt, Anne E. Miller, Elizabeth M. Michaud, Phillip C. Falkner, J. Chris Coetzee

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