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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT06025734
Eligibility Criteria:
Inclusion Criteria:
* Age 8-18
* Patient at TSRH
* Diagnosis of lumbosacral spina bifida (myelomeningocele, meningocele, lipoma of spinal cord, myelocystocele, diastematomyelia, fatty/thickened filum)
* Incontinence refractory to compliant catheterization (compliance with catheterization as assessed by their treating provider)
* Patient able and willing to undergo urodynamic testing without sedation
* No surgical reconstruction with the exception of a single appendicovesicostomy (APV)
* No Botox treatments within 1 year of enrollment
* Patient willing and able to stop bladder medications (anticholinergics or beta agonists) 2 weeks prior to pre-intervention bladder diary, questionnaires and UDS
* Patient lives close enough to TSRH and CMC to be willing to return for UDS, teaching, and clinic visits as detailed above
* Patient/family speak English
Exclusion Criteria:
* Ages \<8 or \>18
* Diagnosis not listed above
* Patients that have received reconstructive surgeries (i.e. augmentation or bladder neck sling) with the exception for a single APV
* Patient received Botox treatment within 1 year of enrollment
* Patient unable or unwilling to stop bladder medications (anticholinergics or beta agonists)
* Patients with high-risk bladders, as assessed by their treating provider (i.e. poorly compliant bladders with high end-fill pressures)
* Non-English speaking
* Patients who are pregnant
* Patients who are suspected of being pregnant
* Patients who are nursing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
18 Years
Study:
NCT06025734
Study Brief:
Protocol Section:
NCT06025734