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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07432659
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years.
* Diagnosis of OAB-wet (OAB with urgency urinary incontinence) documented by clinical diagnosis
* Baseline ≥1 UUI episode/day averaged over a 3-day diary
* Is on a stable pharmacotherapy for OAB for ≥4 weeks, with intent to remain on their medication regimen for the duration of this study
* Has the ability to complete bladder diaries, questionnaires, and attend follow-up visits
* Cognitively intact adult and able to understand study procedures and provide informed consent independently
Exclusion Criteria:
* Neurologic disease affecting bladder function, including multiple sclerosis, spinal cord injury, Parkinson's disease, or other neurogenic bladder conditions.
* Significant pelvic organ prolapses or other pelvic pathology likely to interfere with bladder emptying, neuromodulation efficacy, or study assessments in the opinion of the investigator
* Active urinary tract infection or unexplained hematuria at screening
* Clinically significant post-void residual volume above threshold (e.g., \>100 mL)
* History of, failure of, or current use of neuromodulation therapies, including percutaneous or transcutaneous tibial nerve stimulation, sacral neuromodulation (InterStim), implantable tibial devices (eCoin)
* Intravesical botulinum toxin injections less than 9 months prior to entry into the study
* Pregnancy or plans to become pregnant during study participation, and women of childbearing age not using contraception. A urine pregnancy test will be performed for women of childbearing potential to confirm non-pregnant status prior to enrollment.
* Contraindications to electrical stimulation (cardiac pacemaker or implanted defibrillator without physician clearance, unhealed wounds near stimulation site, metal implants in the ankle region)
* Significant uncontrolled medical conditions, such as unstable cardiac disease, poorly controlled diabetes mellitus, severe peripheral edema, or severe peripheral neuropathy that may affect lower-limb sensation or response to stimulation in the opinion of the investigator
* Pelvic malignancy or prior pelvic radiotherapy.
* Current participation in another investigational drug or device trial, or use of an investigational therapy within the last 30 days
* Known hypersensitivity or intolerance to materials used in the ZIDA device (electrode adhesives, conductive gels)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07432659
Study Brief:
Protocol Section:
NCT07432659