Tensi+ European Registry

Recruiting

• Conditions: Overactive Bladder

• Registration Number: NCT07205445
• Lead Sponsor: Stimuli Technology

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) 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-27
• Status Verified: 2025-09
• Study First Submitted: 2025-09-16
• Study First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Primary Completion: 2027-10-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Patient-reported Outcomes Measures (PROMs)	0; 3 and 12 months	Urinary symptoms by filling up International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) which is a questionnaire intended to assess male storage, voiding and incontinence symptoms. Lower scores are typically associated with reduced symptom severity.
Quality of life measures	0; 3 and 12 months	By filling up International Consultation on Incontinence Questionnaire - OAB quality of life (ICIQ-OABqol) which is a questionnaire evaluating quality of life in patients with overactive bladder. Lower scores are typically associated with improved quality of life.

Trial Locations

Locations (15)

HFME - Hospices Civils de Lyon; 🇫🇷 Bron, France

CHU de Rennes; 🇫🇷 Rennes, France

CHU de Rouen - Hôpital Charles Nicolle; 🇫🇷 Rouen, France

Nuova Villa Esther; 🇮🇹 Avellino, Italy

Azienda Ospedaliero-Universitaria Careggi; 🇮🇹 Florence, Italy

Hesperia Hospital; 🇮🇹 Modena, Italy

Santa Maria la Gruccia Hospital; 🇮🇹 Montevarchi, Italy

Policlinico Tor Vergata; 🇮🇹 Roma, Italy

Casa di Cura Villa Stuart; 🇮🇹 Roma, Italy

Villa Salaria Hospital; 🇮🇹 Roma, Italy

Scroll for more (5 remaining)