Tensi+ European Registry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 15
- Primary Endpoint
- Subjective improvement
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
Subjective improvement
Time Frame: 3 and 12 months
The Patient Global Impression of Improvement (PGI-I) uses a 7-point scale, where post-treatment condition is rated as follows: 1. = Very much better 2. = Much better 3. = A little better 4. = No change 5. = A little worse 6. = Much worse 7. = Very much worse. For analysis, patients with a PGI-I score of 1, 2, or 3 are typically considered responders, reflecting meaningful improvement.
Secondary Outcomes
- Patient-reported Outcomes Measures (PROMs)(0; 3 and 12 months)
- Quality of life measures(0; 3 and 12 months)