Tensi+ European registry for overactive bladder

Tensi+ European Registry

This registry will collect information on adults with overactive bladder who use the Tensi+ posterior tibial nerve stimulation device to see if it helps symptoms and is safe over one year.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Stimuli Technology (Industry-sponsored)
• Locations: 17 sites (Bron and 16 other locations)
• Trial ID: NCT07205445 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with idiopathic or neurological overactive bladder who can use a posterior tibial nerve stimulation device and complete a voiding diary are the ideal candidates.

Not a fit: People with pacemakers or other electronic implants, nearby metal implants, pregnancy, ankle or skin problems at the electrode site, cognitive impairment, or inability to complete a voiding diary are unlikely to benefit or cannot participate.

Why it matters

Potential benefit: If successful, Tensi+ could offer a noninvasive nerve stimulation option to reduce urgency, frequency, and incontinence episodes.

How similar studies have performed: Early clinical reports and prior posterior tibial nerve stimulation work have shown favorable safety and symptom improvement, but larger real-world registries are limited.

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).

Where this trial is running

Bron and 16 other locations

• 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 (Not_yet_recruiting)
• Azienda Ospedaliero-Universitaria Careggi — Florence, Italy (Not_yet_recruiting)
• Hesperia Hospital — Modena, Italy (Not_yet_recruiting)
• Santa Maria la Gruccia Hospital — Montevarchi, Italy (Not_yet_recruiting)
• Policlinico Tor Vergata — Roma, Italy (Not_yet_recruiting)
• Casa di Cura Villa Stuart — Roma, Italy (Not_yet_recruiting)
• Villa Salaria Hospital — Roma, Italy (Not_yet_recruiting)
• Azienda Ospedaliero Universitaria Sant'Andrea — Roma, Italy (Not_yet_recruiting)
• Azienda Ospedaliero Universitaria Sant'Andrea — Roma, Italy (Not_yet_recruiting)
• Clinica Nuova Villa Claudia — Roma, Italy (Not_yet_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)

Study contacts

• Study coordinator: Akshaya Mariadassou

Conditions Overactive Bladder; Urology; TENS; Overactive bladder