Tensi+ European Registry
Stimuli Technology
500 participants
Feb 27, 2025
OBSERVATIONAL
Conditions
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. 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.
Eligibility
Inclusion Criteria2
- Age ≥ 18 years
- Patients suffering from idiopathic or neurological overactive bladder
Exclusion Criteria7
- 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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Interventions
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.
Locations(17)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07205445