Overactive Bladder (OAB)NCT06659536
Cefar URO - Symptomatic Treatment of Overactive Bladder
A study testing Transcutaneous Tibial Nerve Stimulation (TTNS) with the Cefar Uro Device in people with Overactive Bladder (OAB) and Refractory Overactive Bladder, run by DJO UK Ltd at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder (OAB), Refractory Overactive Bladder, Urinary Urgency and Frequency
- What is being tested?
- Transcutaneous Tibial Nerve Stimulation (TTNS) with the Cefar Uro Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2026to Oct 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Neuro-Urology Department, Tenon Hospital
Paris, 75020
About this study
Official title: 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.
Read the detailed description
The objectives of this prospective study are to assess the performance and safety of Cefar URO when used at home by enrolled patients using the P4 program pre-set parameters i.e. frequency 20Hz, pulse width 200μs, for 12 weeks.
Adult patients who require symptomatic treatment of urge incontinence and associated symptoms with overactive bladder (including refractory overactive bladder of idiopathic or neurogenic origin), will undergo Transcutaneous Posterior Tibial Nerve Stimulation with the Cefar URO device at home.
The diagnosis of OAB is made by the Investigator on the basis of clinical symptoms in routine practice.
The assessment of symptoms and quality of life of patients will be completed before treatment (Baseline) and after 6 and 12 weeks of treatment with the Cefar URO device. An additional assessment of the maintenance of symptoms and quality of life will be performed 4 weeks after end of the per protocol treatment.
The tests used to assess symptoms and quality of life are and compliance with treatment are:
- the Overactive bladder Questionnaire (OAB-q) SF 4 Weeks Recall (6-item Symptom Bother Scale and a 13-item HRQL Scale)
- the 3-day bladder diary
- A 6-point Likert scale to assess faecal incontinence (only in case patients experience faecal incontinence at baseline)
- Compliance diary
The following parameters setting (preset program P4) will be used for treatment of all enrolled subjects with the Cefar URO device:
- frequency of 20Hz
- pulse width of 200 μs
- duration: 30 minutes per treatment.
- treatment frequency: subjects will be recommended to have 7 treatment sessions per week for a total of 12 weeks (84 treatments total), and anyway no less that one treatment per week.
The electrodes will be placed in the medial ankle as according to the device IFU.
Patients will be asked to record each treatment session performed on the patient's diary, in order to assess compliance with the scheduled treatment plan.
The subjects will be treated for a period of 12 weeks with the Cefar URO device as per the treatment protocol described above.
After completion of the per protocol treatment period, the subjects will be followed up for an additional period of 4 weeks. During these four weeks, patients will be asked to continue performing the treatment according to their needs and according to the Investigator's instructions (Maintenance treatment protocol). No prescription about the number of treatments is imposed by the protocol during this period.
The subjects will be evaluated at study site for 6 on site visits and 10 weekly phone contacts, as detailed in the study flowchart at the end of this section.
Weekly follow-up phone contacts with the patients will be performed during the 12 weeks of the per protocol treatment with the exception of the weeks when an onsite visit is scheduled. One additional phone call will be performed during the exploratory long term 4 weeks follow up period (Maintenance period). These regular contacts serve to remind the patient to follow the treatment plan and to complete the self-reported questionnaires accurately. Additionally, at each phone contact patients will be asked to report if any issues/adverse events have been occurred since the last visit or phone contact. The regular phone contact with patients should help in keeping the adherence to the protocol and have a higher compliance to the treatment.
- Being tested
- Transcutaneous Tibial Nerve Stimulation (TTNS) with the Cefar Uro Device
- Keywords
- Urinary urgency, Overactive Bladder (OAB), Transcutaneous Tibial Nerve Stimulation (TTNS), Cefar Uro
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Tibial Nerve Stimulation (TTNS) with the Cefar Uro DeviceDevice
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 group | Role | What they receive |
|---|---|---|
| Transcutaneous Tibial Nerve Stimulator (TTNS) with the Cefar Uro Device | Experimental | Patients will undergo Transcutaneous Posterior Tibial Nerve Stimulation with the Cefar URO device. The following parameters setting (preset program P4) will be used for treatment of all enrolled subjects:
* frequency of 20Hz
* pulse width of 200 μs
* duration: 30 minutes per treatment.
* treatment frequency: subjects will be recommended to have 7 treatment sessions per week for a total of 12 weeks (84 treatments total), and anyway no less that one treatment per week.
The electrodes will be placed in the medial ankle as according to the device IFU. Receives: Device: Transcutaneous Tibial Nerve Stimulation (TTNS) with the Cefar Uro Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
- adverse events/malfunctions/complications reported during the study. Subjects and Investigators will be prompted to record such issues on the AE evaluation form.
Measured: From enrollment to the end of Treatment at 16 weeks.
Frequency of Overactive Bladder Symptoms
- 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.
Measured: From enrollment to the end of Treatment at 12 weeks.
Secondary outcomes (2)
Number of Urinary Urgency and Urinary Frequency Episodes
- change in the number of episodes of Urinary Urgency and Urinary Frequency measured at 12 weeks compared to baseline, measured by means of 3-day bladder patient diary. This will quantify the average number of urgency and frequency episodes per day over three consecutive days, allowing for a direct comparison of baseline and 12-week data.
Measured: From enrollment to the end of Treatment at 12 weeks.
Change in Quality of Life
- change in Health-Related Quality of Life as shown by a reduction in the Overactive Bladder-questionnaire-Short Form (OAB-q-SF), Health-Related Quality of Life (HRQoL) (13 items) at 12 weeks relative to baseline, based on patient self reported outcomes.
To assess the quality of life, the lowest score is 13 and the highest is 78. Higher scores will be indicative of better HRQL.
Measured: From enrollment to the end of Treatment at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start19 Jan 2026
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder (OAB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DJO UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Donawa Lifescience Consulting S.r.l.
- Responsible party
- Sponsor
- Investigators
- Gérard Amarenco, Pr., Principal investigator, Service de Neuro-Urologie, Hôpital Tenon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659536
- Sponsor's protocol ID
- ENOVIS-S-INP-0003
- Status last verified
- Jan 2026
- First submitted
- 22 Oct 2024
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No