Tensi+ European Registry
1 other identifier
observational
500
3 countries
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2025
Typical duration for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 27, 2025
CompletedFirst Submitted
Initial submission to the registry
September 16, 2025
CompletedFirst Posted
Study publicly available on registry
October 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
October 3, 2025
September 1, 2025
2.6 years
September 16, 2025
September 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Subjective improvement
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.
3 and 12 months
Secondary Outcomes (3)
Patient-reported Outcomes Measures (PROMs)
0; 3 and 12 months
Patient-reported Outcomes Measures (PROMs)
0; 3 and 12 months
Quality of life measures
0; 3 and 12 months
Other Outcomes (6)
Patient-reported Outcomes Measures (PROMs)
0; 3 and 12 months
Evaluation of voiding frequency
0; 3 and 12 months
Evaluation of urgency
0; 3 and 12 months
- +3 more other outcomes
Interventions
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.
Eligibility Criteria
Age ≥ 18 years Overactive bladder symptoms
You may qualify if:
- Age ≥ 18 years
- Patients suffering from idiopathic or neurological overactive bladder
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
HFME - Hospices Civils de Lyon
Bron, 69500, France
CHU de Rennes
Rennes, 35033, France
CHU de Rennes
Rennes, 35033, France
CHU de Rouen - Hôpital Charles Nicolle
Rouen, 76031, France
Nuova Villa Esther
Avellino, 83100, Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, 50139, Italy
Hesperia Hospital
Modena, 41125, Italy
Santa Maria la Gruccia Hospital
Montevarchi, 52025, Italy
Policlinico Tor Vergata
Roma, 00133, Italy
Casa di Cura Villa Stuart
Roma, 00135, Italy
Villa Salaria Hospital
Roma, 00139, Italy
Azienda Ospedaliero Universitaria Sant'Andrea
Roma, 00189, Italy
Azienda Ospedaliero Universitaria Sant'Andrea
Roma, 00189, Italy
Clinica Nuova Villa Claudia
Roma, 00191, Italy
Bristol Urological Institute
Bristol, BS10 5NB, United Kingdom
Addenbrooke's Hospital, Cambridge University Hospital Trust
Cambridge, CB22 0QQ, United Kingdom
University College Hospital London
London, NW1 2BU, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2025
First Posted
October 3, 2025
Study Start
February 27, 2025
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
October 3, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share