Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT01666405
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01666405
Study Brief:
Protocol Section:
NCT01666405