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

Pilot Study

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