Tensi+ European Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tensi+.
- Who it may be relevant to
- Registry conditions: Overactive Bladder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, Italy, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Tensi+
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.
Primary outcome measures
- Subjective improvement [Time frame: 3 and 12 months]
Secondary outcome measures (3)
- Patient-reported Outcomes Measures (PROMs) [Time frame: 0; 3 and 12 months]
- Patient-reported Outcomes Measures (PROMs) [Time frame: 0; 3 and 12 months]
- Quality of life measures [Time frame: 0; 3 and 12 months]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 10 centers
- Nuova Villa Esther — Avellino
- Azienda Ospedaliero-Universitaria Careggi — Florence
- Hesperia Hospital — Modena
- Santa Maria la Gruccia Hospital — Montevarchi
- Policlinico Tor Vergata — Roma
- Casa di Cura Villa Stuart — Roma
- Villa Salaria Hospital — Roma
- Azienda Ospedaliero Universitaria Sant'Andrea — Roma
- … and 2 more centers
France · 4 centers
- HFME - Hospices Civils de Lyon — Bron
- CHU de Rennes — Rennes
- CHU de Rennes — Rennes
- CHU de Rouen - Hôpital Charles Nicolle — Rouen
United Kingdom · 3 centers
- Bristol Urological Institute — Bristol
- Addenbrooke's Hospital, Cambridge University Hospital Trust — Cambridge
- University College Hospital London — London
Identifiers
NCT: NCT07205445 · 2024-A01420-47