Cefar URO - Symptomatic Treatment of Overactive Bladder

NCT06659536 · tracked via the Priya Life Science France tracker

Sponsor

DJO UK Ltd

Phase

Not applicable

Started

2026-01-19

Last updated

2026-08-28

Condition(s) studied

Overactive Bladder (OAB)Refractory Overactive BladderUrinary Urgency and Frequency

Investigational drug(s) / intervention(s)

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

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

Study summary

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Incidence of Treatment-Emergent Adverse Events — From enrollment to the end of Treatment at 16 weeks.
\- adverse events/malfunctions/complications reported during the study. Subjects and Investigators will be prompted to record such issues on the AE evaluation form.
Frequency of Overactive Bladder Symptoms — From enrollment to the end of Treatment at 12 weeks.
\- change in symptoms, at 12 weeks, quantified as the mean change from baseline on the Overactive Bladder-questionnaire-Short Form (OAB-q-SF), Symptoms bother scale (6 items) based on patient self-reporting. The lowest score for symptoms is 6, and the highest is 36. Higher score values are indicative of grater symptom bother and lower scores indicate minimal symptom bother. As per the literature (Zonic-Imamovic et al.,2021), we may expect an approximate mean reduction of the Symptoms Bother scale of 10.4 points at 12 weeks compared to the baseline measurement.

Trial sites (1)

Facility	City	Region	Status
Neuro-Urology Department, Tenon Hospital	Paris	France	Recruiting

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Comparative Study of the Efficacy of Treatment of Idiopathic Overactive Bladder (OAB) in Children: Oxybutynine vs. Transcutaneous Neurostimulation Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06659536 on ClinicalTrials.gov ↗ ← All trials in France