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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT04570605
Eligibility Criteria:
Inclusion Criteria:
* Toilet trained (age 6) to age 17
* Diagnosis of urinary dysfunction, voiding dysfunction, overactive bladder, urgency incontinence, nocturnal enuresis. (These patients may also have an element of bowel dysfunction; however, we will not include a patient who had ONLY bowel dysfunction and NOT a voiding dysfunction).
Exclusion Criteria:
* Known neurologic diagnosis - such as myelomeningocele, caudal regression
* Known seizure disorder
* Age \< 6 or \> 17
* Lack of follow-up within 6 months of treatment
* Pacemaker, vagal nerve stimulator, or other implanted electrical device
* Intolerance of electrical nerve stimulation
* Pregnancy
* Implanted metal hardware
* Open sores or wounds over the sacral area
* Currently catheterizing for bladder drainage
* Known anatomic lower urinary tract abnormality (may be congenital or iatrogenic)
* Bowel only voiding dysfunction (Constipation ICD-10 K59.00)
* Non-English speaking families
* Families with health literacy precluding completion of questionnaires and voiding diaries
* Concurrent use of anticholinergics, alpha blockers or beta agonists for urologic treatments
* Untreated urinary tract infection
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT04570605
Study Brief:
Protocol Section:
NCT04570605