Cefar URO - Symptomatic Treatment of Overactive Bladder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDJO UK Ltd
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Transcutaneous Tibial Nerve Stimulation (TTNS) with the Cefar Uro Device
Treatment groups
53 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov