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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT02556151
Eligibility Criteria:
Inclusion Criteria:
1. Recurrent episodes of FI for 6 months;
2. No mucosal disease (colonoscopy + biopsy); and
3. On a 2-week stool diary patients reported at least one episode of solid or liquid FI/week.
Exclusion Criteria: Patients with
1. severe diarrhea (\>6 liquid stools/day, Bristol scale \>6);
2. on opioids, tricyclics (except on stable doses \> 3months);
3. active depression;
4. comorbid illnesses, severe cardiac disease, chronic renal failure or previous gastrointestinal surgery except cholecystectomy and appendectomy;
5. neurologic diseases (e.g. head injury, epilepsy, multiple sclerosis, strokes, spinal cord injury);
6. impaired cognizance (mini mental score of \< 15/25) and/or legally blind;
7. metal implants, pacemakers;
8. previous pelvic surgery, bladder repair, radical hysterectomy;
9. ulcerative and Crohn's colitis;
10. rectal prolapse, anal fissure, anal surgery or inflamed hemorrhoids;
11. pregnant women
12. nursing mothers.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT02556151
Study Brief:
Protocol Section:
NCT02556151