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Tensi+ European Post-Market Clinical Follow-Up

Recruitingn/aAges 18 Years - anyAllStimuli Technology
NCT07205445 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years * Patients suffering from idiopathic or neurological overactive bladder Exclusion Criteria: * 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).
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What it tests

  • Tensi+
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Where

17 sites
HFME - Hospices Civils de Lyon
Bron, France
CHU de Rennes
Rennes, France
CHU de Rennes
Rennes, France
CHU de Rouen - Hôpital Charles Nicolle
Rouen, France
Nuova Villa Esther
Avellino, Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, Italy
Hesperia Hospital
Modena, Italy
Santa Maria la Gruccia Hospital
Montevarchi, Italy

…and 9 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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