Tensi+ European Registry

Stimuli Technology

Status: Enrolling

Conditions: Overactive Bladder

Treatments: Device: Tensi+

Study type: Observational

Funder types: Industry

Identifiers

NCT07205445

2024-A01420-47

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).