Cefar URO: a home TTNS test for adults with overactive bladder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, post-market investigation collects safety and performance data for the Cefar URO device used at home with preset program P4 (20 Hz, 200 μs) in adults with urge incontinence due to overactive bladder. Participants use TTNS for 12 weeks, with symptom and quality-of-life assessments at baseline, 6 weeks, 12 weeks, and a follow-up 4 weeks after treatment ends. Outcomes include the Overactive Bladder Questionnaire, a 3-day bladder diary, a faecal incontinence scale (if applicable), and a compliance diary. The study aims to fill the data gap for this specific preset program compared to known data for related devices. Eligible adults with idiopathic or neurogenic OAB, including refractory cases, must self-administer TTNS at home and meet stabilization criteria if on concomitant therapies.

Why it matters

Who can join: the full rules

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

Where it's running

• Neuro-Urology Department, Tenon Hospital
  Paris, France Recruiting

Study contacts

• Principal investigator: Gérard Amarenco, Pr. — Service de Neuro-Urologie, Hôpital Tenon
• Study coordinator: Veronica Sebeo
• Email: prci@enovis.com
• Phone: +49 15146128712

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.