Age

18–any

Sex

ALL

Healthy volunteers

Not accepted

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.)

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

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