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 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT06661057
Eligibility Criteria:
Inclusion Criteria:
* Injury level above T10.
* Diagnosis of neurogenic bladder (Performing intermittent catheterization).
* English or Spanish Speaker.
* Toe flexion upon tibial nerve stimulation with transcutaneous electric stimulation.
* No adverse events during the Vivally 5-minute trial
Exclusion Criteria:
* Intradetrusor Botulinum Toxin within six months.
* Presence of urinary tract infection (UTI) symptoms.
* Pregnancy or breastfeeding.
* Known allergy to electrode or device materials.
* Known intolerance to leg electric stimulation
* Patient with no smartphone access.
* Pain/discomfort or adverse reaction with the trial of toe flexion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06661057
Study Brief:
Protocol Section:
NCT06661057