RECRUITING Not applicable ClinicalTrials.gov

Cefar URO - Symptomatic Treatment of Overactive Bladder

Sponsor: DJO UK Ltd • ClinicalTrials.gov ID: NCT06659536

Registry updated: 2026-08-28

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Transcutaneous Tibial Nerve Stimulation (TTNS) with the Cefar Uro Device (Device)
Transcutaneous Tibial Nerve Stimulation (TTNS) with the Cefar URO device 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.

Eligibility criteria

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

Conditions

Overactive Bladder (OAB) Refractory Overactive Bladder Urinary Urgency and Frequency

Locations

Neuro-Urology Department, Tenon Hospital — Paris, France

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment