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 @ 4:30 AM
Ignite Modification Date:
2025-12-25 @ 4:30 AM
NCT ID:
NCT00292318
Eligibility Criteria:
Inclusion Criteria:
Male or female patient with inadequate relief of fecal incontinence symptoms after documented management in the primary care setting. They must have:
* a mini-mental status score of \> 18
* an "up and go" test score of \< 30 seconds
* bowel habit diary showing \> one episode of fecal incontinence episode per week
Exclusion Criteria:
* patients who previously underwent a course of biofeedback for fecal incontinence
* age \< 18 years
* major neurological disease
* significant cognitive impairment (mini mental status examination score \< 18), functional impairment (up and go score of \> 30 seconds)
* active inflammatory bowel disease
* history of spinal cord injury
* rectal resection
* ileal pouch procedures
* latex allergy
* significantly distressed and unable to consider informed consent issues adequately
* needing urgent medical referral
* insufficient written English skills to complete the questionnaires
* require surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00292318
Study Brief:
Protocol Section:
NCT00292318