Post-market Prospective Clinical Investigation on the Symptomatic Treatment of Urge Incontinence in Adults With Overactive Bladder With Cefar URO
A Post-Market Prospective Clinical Investigation to collect PMCF data on the safety and performance of the Cefar URO device when using the preset program P4 (parameter setting: frequency 20Hz, pulse width 200μs) for the symptomatic treatment of urge incontinence in adults with overactive bladder in accordance with the approved labelling. The Cefar URO device features four pre-set programs (P1, P2, P3 and P4) and three custom programs. Although supporting data on the preset programs P1, P2, P3 are available for the clinically equivalent UROstim2 device, program P4 is unique to Cefar URO. Program P4 utilizes the parameters 20Hz and 200μs which are commonly reported in the literature for the stated indications but for which no data is available for the clinically equivalent UROstim2 device. The present study is therefore aimed to cover this data gap.
• 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