Tensi+ European Registry
Recruiting now
Conditions studied: Overactive Bladder
In brief
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.
Key facts
- Study ID
- NCT07205445
- Run by
- Stimuli Technology
- People needed
- 500
- Starts
- 2025-02-27
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2025-10-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years
- Patients suffering from idiopathic or neurological overactive bladder
You may not qualify if…
- 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).
Where it is running
- HFME - Hospices Civils de Lyon — Bron, France (enrolling)
- CHU de Rennes — Rennes, France (enrolling)
- CHU de Rennes — Rennes, France (enrolling)
- CHU de Rouen - Hôpital Charles Nicolle — Rouen, France (enrolling)
- Nuova Villa Esther — Avellino, Italy
- Azienda Ospedaliero-Universitaria Careggi — Florence, Italy
- Hesperia Hospital — Modena, Italy
- Santa Maria la Gruccia Hospital — Montevarchi, Italy
- Policlinico Tor Vergata — Roma, Italy
- Casa di Cura Villa Stuart — Roma, Italy
- Villa Salaria Hospital — Roma, Italy
- Azienda Ospedaliero Universitaria Sant'Andrea — Roma, Italy
- Azienda Ospedaliero Universitaria Sant'Andrea — Roma, Italy
- Clinica Nuova Villa Claudia — Roma, Italy
- Bristol Urological Institute — Bristol, United Kingdom
- Addenbrooke's Hospital, Cambridge University Hospital Trust — Cambridge, United Kingdom
- University College Hospital London — London, United Kingdom
Full record on ClinicalTrials.gov
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