Overactive BladderNCT07205445
Tensi+ European Post-Market Clinical Follow-Up
An observational study of Overactive Bladder, run by Stimuli Technology at 17 sites in 3 countries.
Trial summary
Tensi+ (Stimuli Technology, Boulogne Billancourt, France) is a newly released, medical transcutaneous-posterior tibial nerve stimulation (TC-pTNS) device marketed for overactive bladder (OAB) management. Preliminary studies have shown a favorable safety and efficacy profile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Tensi+
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 17 sitesin 3 countries
- Study dates
- 27 Feb 2025to 1 Oct 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Age ≥ 18 years Overactive bladder symptoms
Who may be able to join
- Age ≥ 18 years
- Patients suffering from idiopathic or neurological overactive bladder
Who cannot join
- Patients with pacemaker, defibrillator, or any other electronic implant;
- Patients with metal implant near the stimulation area;
- Pregnant women;
- People suffering from ankle joint problems, swollen ankles or a dermatological condition or damaged skin in the area where the electrodes are to be placed;
- Patient with cognitive impairment;
- Inability to complete a voiding diary;
- No social security cover (for applicable countries).
Trial locations and contacts
17 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 3 countries
Italy10 sites, 10 recruiting
- Recruiting
Nuova Villa Esther
Avellino, 83100
Luca Cindolo, MD, PhD, +39 0825 772111, lucacindolo@virgilio.it
- Not yet recruiting
Azienda Ospedaliero-Universitaria Careggi
Florence, 50139
Stefania Musco, MD, PhD, +39 055 794 111, stefaniamusco@hotmail.com
- Recruiting
Hesperia Hospital
Modena, 41125
Luca Cindolo, MD, PhD, +39 059 449111, lucacindolo@virgilio.it
- Recruiting
Santa Maria la Gruccia Hospital
Montevarchi, 52025
Marilena Gubbiotti, MD, PhD, +39 055 9106695, marilena.gubbiotti@gmail.com
- Not yet recruiting
Policlinico Tor Vergata
Roma, 00133
Enrico Finazzi Agrò, MD, PhD, +39 06 2090 2977, finazzi.agro@med.uniroma2.it
- Recruiting
Casa di Cura Villa Stuart
Roma, 00135
Luca Cindolo, MD, PhD, +39 06 3552 8500, lucacindolo@virgilio.it
- Recruiting
Villa Salaria Hospital
Roma, 00139
Luca Cindolo, MD, PhD, +39 06 887 0041, lucacindolo@virgilio.it
- Recruiting
Azienda Ospedaliero Universitaria Sant'Andrea
Roma, 00189
Cosimo De Nunzio, MD, PhD, +39 06 3377 5929, cosimodenunzio@virgilio.it
- Recruiting
Azienda Ospedaliero Universitaria Sant'Andrea
Roma, 00189
Antonio Nacchia, MD, PhD, +39 06 3377 5929, antonionacchia7@gmail.com
- Recruiting
Clinica Nuova Villa Claudia
Roma, 00191
Luca Cindolo, MD, PhD, +39 06 367971, lucacindolo@virgilio.it
France4 sites, 4 recruiting
- Recruiting
HFME - Hospices Civils de Lyon
Bron, 69500
Gery Lamblin, MD, PhD, +334 27 85 53 53, gery.lamblin@chu-lyon.fr
- Recruiting
CHU de Rennes
Rennes, 35033
Benoît Peyronnet, MD, PhD, +332 99 28 90 48, peyronnetbenoit@hotmail.fr
- Recruiting
CHU de Rennes
Rennes, 35033
Juan Penafiel, MD, jfcopenafiel@gmail.com
- Recruiting
CHU de Rouen - Hôpital Charles Nicolle
Rouen, 76031
Jean-Nicolas Cornu, MD, PhD, +332 32 88 03 41, jeannicolas.cornu@gmail.com
United Kingdom3 sites, 3 recruiting
- Not yet recruiting
Bristol Urological Institute
Bristol, BS10 5NB
Hashim Hashim, MD, PhD, +44 117 950 5050, h.hashim@gmail.com
- Not yet recruiting
Addenbrooke's Hospital, Cambridge University Hospital Trust
Cambridge, CB22 0QQ
Suzanne Biers, MD, +44 1223 216575, suzanne.biers@.nhs.net
- Not yet recruiting
University College Hospital London
London, NW1 2BU
Mahreen Pakzad, MD, +44 20 3456 7890, mahreen.pakzad@nhs.net
About this study
Tensi+ (Stimuli Technology, Boulogne Billancourt, France) is a newly released, medical transcutaneous-posterior tibial nerve stimulation (TC-pTNS) device marketed for overactive bladder (OAB) management. Preliminary studies have shown a favorable safety and efficacy profile. The goal of the present registry is to collect data among an important number of patients to assess the efficacy, safety and potential predictive factors of success in a current clinical setting over a total period of 1 year.
- Conditions
- Overactive Bladder
- Being tested
- Tensi+
- Keywords
- Urology, TENS, Overactive bladder
- 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.
Tensi+Device
Tensi+ (Stimuli Technology, Boulogne Billancourt, France) is a newly released, medical transcutaneous-posterior tibial nerve stimulation (TC-pTNS) device marketed for overactive bladder (OAB) management.
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective improvement
The Patient Global Impression of Improvement (PGI-I) uses a 7-point scale, where post-treatment condition is rated as follows:
- = Very much better
- = Much better
- = A little better
- = No change
- = A little worse
- = Much worse
- = Very much worse.
For analysis, patients with a PGI-I score of 1, 2, or 3 are typically considered responders, reflecting meaningful improvement.
Measured: 3 and 12 months
Secondary outcomes (3)
Patient-reported Outcomes Measures (PROMs)
Urinary symptoms by filling up International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) which is a questionnaire intended to assess female storage, voiding and incontinence symptoms. Lower scores are typically associated with reduced symptom severity.
Measured: 0; 3 and 12 months
Patient-reported Outcomes Measures (PROMs)
Urinary symptoms by filling up International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) which is a questionnaire intended to assess male storage, voiding and incontinence symptoms. Lower scores are typically associated with reduced symptom severity.
Measured: 0; 3 and 12 months
Quality of life measures
By filling up International Consultation on Incontinence Questionnaire - OAB quality of life (ICIQ-OABqol) which is a questionnaire evaluating quality of life in patients with overactive bladder. Lower scores are typically associated with improved quality of life.
Measured: 0; 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start27 Feb 2025
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Stimuli Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205445
- Sponsor's protocol ID
- 2024-A01420-47
- Status last verified
- Oct 2026
- First submitted
- 16 Sep 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tensi+ European Post-Market Clinical Follow-Up
- ClinicalTrials.gov ID
- NCT07205445
- Acronym / sponsor ID
- 2024-A01420-47
- Conditions
- Overactive Bladder
- Keywords
- Urology, TENS, Overactive bladder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Stimuli TechnologyIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tensi+ (Stimuli Technology, Boulogne Billancourt, France) is a newly released, medical transcutaneous-posterior tibial nerve stimulation (TC-pTNS) device marketed for overactive bladder (OAB) management. Preliminary studies have shown a favorable safety and efficacy profile. The goal of the present registry is to collect data among an important number of patients to assess the efficacy, safety and potential predictive factors of success in a current clinical setting over a total period of 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Age ≥ 18 years Overactive bladder symptoms
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Patients suffering from idiopathic or neurological overactive bladder
Key exclusion criteria (7 listed)
- Patients with pacemaker, defibrillator, or any other electronic implant;
- Patients with metal implant near the stimulation area;
- Pregnant women;
- People suffering from ankle joint problems, swollen ankles or a dermatological condition or damaged skin in the area where the electrodes are to be placed;
- Patient with cognitive impairment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tensi+Tensi+ (Stimuli Technology, Boulogne Billancourt, France) is a newly released, medical transcutaneous-posterior tibial nerve stimulation (TC-pTNS) device marketed for overactive bladder (OAB) management. | Device | – |
Primary outcome
Subjective improvement
Time frame: 3 and 12 months
The Patient Global Impression of Improvement (PGI-I) uses a 7-point scale, where post-treatment condition is rated as follows: 1. = Very much better 2. = Much better 3. = A little better 4. = No change 5. = A little worse 6. = Much worse 7. = Very much worse. For analysis, patients with a PGI-I score of 1, 2, or 3 are typically considered responders, reflecting meaningful improvement.
3 secondary outcomes
Patient-reported Outcomes Measures (PROMs)
Time frame: 0; 3 and 12 months
Patient-reported Outcomes Measures (PROMs)
Time frame: 0; 3 and 12 months
Quality of life measures
Time frame: 0; 3 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder, run by Stimuli Technology at 17 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Italy, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Akshaya Mariadassou (+331 84 60 48 25, a.mariadassou@stimuli-technology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective improvement (time frame: 3 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.