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Recruiting NCT07205445

Tensi+ European Post-Market Clinical Follow-Up

Conditions: Overactive Bladder

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 500
Sponsor: Stimuli Technology

Location: HFME - Hospices Civils de Lyon Bron

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).

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07205445). StuddyBuddy aggregates publicly available trial information.