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 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT01096459
Eligibility Criteria:
Inclusion Criteria:
1. Male and female patients age 5 and older with spinal dysraphism (ie. myelomeningocele , lipomyelomeningocele, myelocele, meningocele, occulta) with voiding dysfunction on a CIC program for bladder management for at least one year prior to screening.
2. Atonic or hyperreflexic bladder documented by urodynamic testing during screening. .
3. Documented history of no more than one tethered cord surgery/release in the past; must be \> 2 years post tethered cord surgery/release
4. Stable neurogenic bladder dysfunction of at least 1 year or more
5. Normal renal function (cr\<1.5 mg/dl or GFR \>75)
6. Ambulate independently with or without ankle-foot orthotics (AFOs).
7. Catheterized volume must be at least 50% of total bladder capacity.
Exclusion Criteria:
1. History of bladder cancer, augmentation, or radiation
2. Anatomic outlet obstruction or urethral strictures
3. History of untreated vesico-ureteric reflux grade 4 or higher documented on screening video UDT
4. Hydronephrosis grade 3 or higher
5. Presence of an ileal conduit or supra-pubic catheter drainage
6. Subjects with an artificial bladder sphincter
7. Subjects who have had a sling procedure
8. Subjects who have had the mitrofanoff procedure
9. Bladder botox injections within last 12 months
10. Spina Bifida subjects who underwent intrauterine closure of their myelomeningocele
11. Unable to ambulate independently with or without AFOs.
12. Subject is pregnant
13. Contraindications to general anesthesia or surgery
14. Inability to complete follow up visits for 2 years
15. Inability to complete (or have parent complete) self administered questionnaires
16. Subject possesses any other characteristics that, per investigator's judgment, deems them unsuitable (eg increases risk, impairs data collection, etc) for the procedure/study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Study:
NCT01096459
Study Brief:
Protocol Section:
NCT01096459