Tensi+ for Treating Overactive Bladder

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