Clinical Research Directory

Inclusion Criteria: * Adult patients with overactive bladder (including refractory overactive bladder of idiopathic or neurogenic origin) who require symptomatic treatment of urge incontinence and associated symptoms. * Subjects, both male and female, ≥ 18 years of age at the time of consent * Subjects have provided their written consent to participate in the study by signing the Ethics-approved consent form. * Patients are considered able and willing to self-administer transcutaneous tibial nerve stimulator (TTNS) treatment at home, based on Investigator's judgement. * Patients are suitable to receive treatment using the Cefar URO device P4 program pre-set parameters (frequency 20Hz and pulse width 200μs) for 12 weeks, based on Investigator's judgement. * If undergoing pharmacological therapy for incontinence, the therapy must be stabilized for at least 4 weeks before baseline visit Exclusion Criteria: * Pregnancy confirmed by urine test at screening * Urinary tract infection confirmed by urine analysis * Serious secondary illness (such as renal failure, nephrolithiasis, bladder and kidney tumors) * Detrusor-sphincter dyssynergia * Patients who have or have had implantable neurostimulating cardiac demand pacemakers, ICD; or other implantable electronic devices * Subjects who are not able to read and understand the Instructions for Use, warnings, cautions and dangers * Subjects who are not able to read and understand indications and contraindications of the device * Subjects who are not able to sense auditory and visual signals * Patients with anti-incontinence surgery planned during the course of the study * Participation in another clinical study within 30 days prior to screening