Status:

RECRUITING

Tensi+ European Registry

Lead Sponsor:

Stimuli Technology

Conditions:

Overactive Bladder

Eligibility:

All Genders

18+ years

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) manageme...

Eligibility Criteria

Inclusion

  • Age ≥ 18 years
  • Patients suffering from idiopathic or neurological overactive bladder

Exclusion

  • 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).

Key Trial Info

Start Date :

February 27 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

October 1 2027

Estimated Enrollment :

500 Patients enrolled

Trial Details

Trial ID

NCT07205445

Start Date

February 27 2025

End Date

October 1 2027

Last Update

October 3 2025

Active Locations (17)

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Page 1 of 5 (17 locations)

1

HFME - Hospices Civils de Lyon

Bron, France, 69500

2

CHU de Rennes

Rennes, France, 35033

3

CHU de Rennes

Rennes, France, 35033

4

CHU de Rouen - Hôpital Charles Nicolle

Rouen, France, 76031