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 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
NCT ID:
NCT04276350
Eligibility Criteria:
Inclusion Criteria:
* Patients presenting with faecal incontinence
* At least 2 episodes of faecal incontinence per week, St Mark's incontinence score of 5 or greater
* Patients aged 21 years or older
* Prior colonoscopy done to exclude underlying colonic pathology
* Written informed consent obtained
Exclusion Criteria:
* Active inflammation of the bowel, including inflammatory bowel disease, infection or perianal sepsis
* Pregnant women
* Current or previous diagnosis of the gastrointestinal tract, genitourinary, or pelvic cancers
* Presence of congenital or acquired neurological deficits (including spinal disorders)
* Previous history of complex major pelvic, anal or rectal surgery
* Previous history of multi-focal or major sphincter injuries or deficits
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT04276350
Study Brief:
Protocol Section:
NCT04276350