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:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-24 @ 1:41 PM
NCT ID:
NCT01254695
Eligibility Criteria:
Inclusion Criteria:
* Informed Consent
* Diagnosed with idiopathic faecal incontinence,incontinence with minor (≤60 degrees) sphincteric defects or incontinence following sphincter repair.
* Medtronic Interstim IPG(pacemaker)implanted for more than 6 months
* minimum one incontinence episodes pr. week during ongoing SNS-therapy
Exclusion Criteria:
* Colorectal surgery after IPG-implantation
* Pregnancy or breastfeeding
* Anal/perianal pain or discomfort
* Patients who are not deemed able to follow the planned testing program, including mental illness or mentally unstable patients
* Medication with known effects on gastrointestinal motility, thyroid disease, diabetes, coeliac, neurological disorders.
* Spinal cord injury
* Irritable Bowel Syndrome
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01254695
Study Brief:
Protocol Section:
NCT01254695