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 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT02349334
Eligibility Criteria:
Inclusion Criteria:
* Faecal incontinence sufficiently severe enough to warrant intervention
* Failure of appropriate conservative therapies
* Age ≥ 18 years
Exclusion Criteria:
* Inability to provide informed consent for the research study
* Inability to fill in the detailed bowel diaries required for outcome assessments (this will exclude participants who do not speak / read English)\*
* Neurological diseases, such as diabetic neuropathy, multiple sclerosis and Parkinson's disease (any participant with painful peripheral neuropathy)
* Anatomical limitations that would prevent successful placement of needle electrode
* Other medical conditions precluding stimulation: e.g. bleeding disorders, certain cardiac pacemakers, peripheral vascular disease or ulcer, lower leg cellulitis
* Congenital anorectal anomalies or absence of native rectum due to surgery
* A cloacal defect
* Present evidence of external full thickness rectal prolapse
* Previous rectal surgery (rectopexy / resection) done \< 12 months ago (24 months for cancer),
* Stoma in situ
* Chronic bowel diseases such as inflammatory bowel disease leading to chronic uncontrolled diarrhoea
* Pregnancy or intention to become pregnant
* Previous experience of SNS or PTNS
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02349334
Study Brief:
Protocol Section:
NCT02349334