Tensi+ for Treating Overactive Bladder

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