Actively Recruiting

Age: 18Years +
All Genders
NCT07205445

Tensi+ European Registry

Led by Stimuli Technology · Updated on 2025-10-03

500

Participants Needed

17

Research Sites

135 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Tensi+ European Registry

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 2 18 years
  • Patients suffering from idiopathic or neurological overactive bladder
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 17 locations

1

HFME - Hospices Civils de Lyon

Bron, France, 69500

Actively Recruiting

2

CHU de Rennes

Rennes, France, 35033

Actively Recruiting

3

CHU de Rennes

Rennes, France, 35033

Actively Recruiting

4

CHU de Rouen - Hôpital Charles Nicolle

Rouen, France, 76031

Actively Recruiting

5

Nuova Villa Esther

Avellino, Italy, 83100

Not Yet Recruiting

6

Azienda Ospedaliero-Universitaria Careggi

Florence, Italy, 50139

Not Yet Recruiting

7

Hesperia Hospital

Modena, Italy, 41125

Not Yet Recruiting

8

Santa Maria la Gruccia Hospital

Montevarchi, Italy, 52025

Not Yet Recruiting

9

Policlinico Tor Vergata

Roma, Italy, 00133

Not Yet Recruiting

10

Casa di Cura Villa Stuart

Roma, Italy, 00135

Not Yet Recruiting

11

Villa Salaria Hospital

Roma, Italy, 00139

Not Yet Recruiting

12

Azienda Ospedaliero Universitaria Sant'Andrea

Roma, Italy, 00189

Not Yet Recruiting

13

Azienda Ospedaliero Universitaria Sant'Andrea

Roma, Italy, 00189

Not Yet Recruiting

14

Clinica Nuova Villa Claudia

Roma, Italy, 00191

Not Yet Recruiting

15

Bristol Urological Institute

Bristol, United Kingdom, BS10 5NB

Not Yet Recruiting

16

Addenbrooke's Hospital, Cambridge University Hospital Trust

Cambridge, United Kingdom, CB22 0QQ

Not Yet Recruiting

17

University College Hospital London

London, United Kingdom, NW1 2BU

Not Yet Recruiting

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Research Team

A

Akshaya Mariadassou

CONTACT

S

Sarah Todeschini

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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