Add-On ZIDA Sock Therapy for Overactive Bladder

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)