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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT00286520
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 or over
* Spinal cord lesion at any level at least 3 months from injury
* At least one or more of the following symptoms:
* Spending ½ hour or more attempting to defecate each day or every second day
* Symptoms of autonomic dysreflexia before or during defecation
* Abdominal discomfort before or during defecation
* Episodes of faecal incontinence once or more per month
* The patient is able to understand the treatment and is willing to comply with the prescribed regimen
* The patient is able to perform transanal colonic irrigation seated on a toilet commode with or without assistance
* Signed informed consent has been obtained
Exclusion Criteria:
* Co-existing major unsolved physical problems due to the injury
* Perform transanal retrograde irrigation on a regular basis
* Evidence of bowel obstruction
* Evidence of inflammatory bowel disease
* History of cerebral palsy or cerebral apoplexy
* Multiple sclerosis
* Diabetic polyneuropathy
* Previous abdominal or perianal surgery (not including minor surgery as appendectomy or haemorrhoidectomy)
* Pregnant or lactating
* Evidence of spinal chock
* Mentally unstable
* Treatment with more than 5 mg prednisolon per day.
* PNS implant (sacral nerve stimulation)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00286520
Study Brief:
Protocol Section:
NCT00286520