Tensi+ European Registry
- Sponsor
- Stimuli Technology
- Study ID
- NCT07205445
- Status
- Recruiting
Conditions
- Overactive Bladder
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Tensi+ — DEVICETensi+ (Stimuli Technology, Boulogne Billancourt, France) is a newly released, medical transcutaneous-posterior tibial nerve stimulation (TC-pTNS) device marketed for overactive bladder (OAB) management.
Study Details
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.
Key Dates
- First listed
- Oct 3, 2025
- Start date
- Feb 27, 2025
- Status verified
- Sep 2025
- Primary completion
- Oct 1, 2027
- Completion
- Oct 1, 2027
Study Design
- Enrollment
- 500 participants (estimated)
Primary Outcome Measure
Subjective improvement [ Time Frame: 3 and 12 months ]
Central Contacts
- Akshaya Mariadassou+331 84 60 48 25
- Sarah Todeschini+331 84 60 48 25
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