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Recruiting NCT07205445

Tensi+ European Registry

Trial Parameters

Condition Overactive Bladder
Sponsor Stimuli Technology
Study Type OBSERVATIONAL
Phase N/A
Enrollment 500
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-02-27
Completion 2027-10-01
Interventions
Tensi+

Brief 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 Criteria

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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