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 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT02361450
Eligibility Criteria:
Inclusion Criteria:
* Patients aging at least 15 years old with Spina Bifida neurological pelvi-perineal sequelae, objected by neurologic exam , functional urinary and/or anorectal and/or neurophysiological data,
* Patients with NBD score above 9,
* Written and informed consent (Minor children may be included with the consent of the two parents).
Exclusion Criteria:
* Patients with psychiatric disorders, cognitive or intellectual disabilities compromising the assessment of primary outcome measure,
* Patients using currently irrigation colonic technique,
* Patients with functional colostomy, known anal or colorectal stenosis, colorectal cancer, acute or chronic inflammatory disease, recent anal or colorectal surgery for less than 3 months, polyp removal for less than 4 weeks, ischemic colitis.
* Patients with urinary trophic or orthopedic disease with planned surgery during inclusion or follow-up periods,
* Patients with progressive anal disease (suppuration, hemorrhoid or rectal prolapse)
* Patient with a hard follow-up ( judged by the investigator)
* Person involved in another clinical trial
* Pregnant women
* Person with a measure of legal protection (guardianship)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT02361450
Study Brief:
Protocol Section:
NCT02361450