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 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT00221767
Eligibility Criteria:
Inclusion Criteria:
* Patient with a complete suprasacral spinal cord injury proved by a clinical exam (perineal reflex preserved) and MRI.
* Clinically stable spinal cord injury for at least 6 months (verified by MRI)
* Patient with an overactive neurogenic bladder (urodynamic testing), incontinence (specific patient diary) and/or risk for the bladder/kidney (intravenous urography, cystography)
* signed informed consent
Exclusion Criteria:
* Injured sacral medullar centers or injured sacral roots
* Non contractile bladder
* Pregnancy or breast feeding
* Contraindication linked to neurostimulator implantation: unwounded cutaneous lesion, prolonged septic state, blood coagulation deficiency, known allergy to one component of the implanted medical device (silicone, platinum, iridium)
* Incapacity to receive an informed consent, incapacity to follow all the study schedule,
* patient not protected by social security
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00221767
Study Brief:
Protocol Section:
NCT00221767