Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence

Inclusion Criteria: * Patient history of chronic FI of more than staining for at least 6 months; staining defined as less than the size of a 25¢ piece (quarter) * Patient reported and/or failed ≥ 2 conservative therapies (e.g., diet/fiber modification, anti-diarrheal medication, pelvic floor muscle training, biofeedback, medical management, etc.) Exclusion Criteria: * Pregnancy or intention to become pregnant during the course of the study * Implanted electro-medical device (i.e., pacemaker, defibrillator, deep brain stimulator, etc.) * Clinically significant neurological diseases or nerve damage impacting tibial nerve or pelvic floor function * Prone to excessive bleeding or bleeding diathesis