Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in France / NCT07205445
Recruiting Observational

Tensi+ European Post-Market Clinical Follow-Up

NCT07205445 · tracked via the Priya Life Science France tracker
Sponsor
Stimuli Technology
Phase
Observational
Started
2025-02-27
Last updated
2026-10-26

Condition(s) studied

Overactive Bladder

Investigational drug(s) / intervention(s)

Tensi+

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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).

Primary outcome measure(s)

  • Subjective improvement — 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.

Trial sites (17)

FacilityCityRegionStatus
HFME - Hospices Civils de Lyon Bron France Recruiting
CHU de Rennes Rennes France Recruiting
CHU de Rennes Rennes France Recruiting
CHU de Rouen - Hôpital Charles Nicolle Rouen France Recruiting
Nuova Villa Esther Avellino Italy Recruiting
Azienda Ospedaliero-Universitaria Careggi Florence Italy Not Yet Recruiting
Hesperia Hospital Modena Italy Recruiting
Santa Maria la Gruccia Hospital Montevarchi Italy Recruiting
Policlinico Tor Vergata Roma Italy Not Yet Recruiting
Casa di Cura Villa Stuart Roma Italy Recruiting
Villa Salaria Hospital Roma Italy Recruiting
Azienda Ospedaliero Universitaria Sant'Andrea Roma Italy Recruiting
Azienda Ospedaliero Universitaria Sant'Andrea Roma Italy Recruiting
Clinica Nuova Villa Claudia Roma Italy Recruiting
Bristol Urological Institute Bristol United Kingdom Not Yet Recruiting
Addenbrooke's Hospital, Cambridge University Hospital Trust Cambridge United Kingdom Not Yet Recruiting
University College Hospital London London United Kingdom Not Yet Recruiting

Other trials for the same condition

Clinical and Urodynamic Assessment of Bladder Sensation in Multiple Sclerosis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07205445 on ClinicalTrials.gov ↗ ← All trials in France