New device aims to calm overactive bladder without drugs

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult subjects aged 22 years or older and, * Diagnosed with OAB symptoms (characterized by urinary urgency, with or without UUI), * Symptoms persisting for at least 3 months, and * Documented with 2 or more urgency episodes per day (with or without incontinence) in two 3-day bladder diaries and, * With at least 11 or more voids per day (urinary frequency) documented in two 3-day bladder diaries * Willing and capable of providing informed consent * Capable of participating in all testing associated with this clinical investigation Exclusion Criteria: * Patients with pacemakers or implanted defibrillators or any other implanted electronic device * Patients prone to excessive bleeding * Patients with nerve damage that could impact the percutaneous tibial nerve or pelvic floor function * Patients who are pregnant or planning to become pregnant while using this product * Patients with ankle joint problems, ankle oedema or dermatological oedema in the area where the electrodes should be placed * Patients wearing a metal implant near the stimulated area * Patient with cognitive deficiency * Administration of intravesical injection of botulinum toxin within 12 months of study enrollment, or treatment within the previous year with other forms neuromodulation for OAB * Patients treated with medical therapy OAB treatment washout inferior to 30 days * Patients with diabetic neuropathy * Patients with uncontrolled diabetes and HbA1c levels above 7% * Guillain-Barré syndrome * Chronic inflammatory demyelinating polyneuropathy (CIDP) * Multiple sclerosis * A primary diagnosis of stress urinary incontinence (SUI) * Patients with recurrent rrinary tract infections (UTIs) defined as more than 2 episodes per year, or with any baseline lower urinary tract pathology identified at the time of the 3-day bladder diary assessment. * Currently participating in another clinical trial