Tensi+ European registry for overactive bladder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter observational registry collecting real-world data on the Tensi+ transcutaneous posterior tibial nerve stimulation device over a 12‑month period. Participating adult patients with idiopathic or neurological overactive bladder will receive Tensi+ per routine clinical practice and complete symptom and voiding diaries. The registry will record safety events, symptom changes, and potential predictors of response in a current clinical setting. Data come from hospital sites in France and are intended to reflect everyday use rather than a controlled intervention protocol.

Why it matters

Who can join: the full rules

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).

Where it's running

• 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
• Hesperia Hospital
  Modena, Italy Recruiting

Study contacts

• Study coordinator: Akshaya Mariadassou
• Email: a.mariadassou@stimuli-technology.com
• Phone: +331 84 60 48 25

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.