Tensi+ European Registry

N/ARecruitingNCT07205445

Stimuli Technology500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Overactive Bladder

Interventions

Tensi+DEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (17)

HFME - Hospices Civils de Lyon

Bron, France

RECRUITING

CHU de Rennes

Rennes, France

Outcomes

Primary Outcomes

Subjective improvement

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.

Time frame: 3 and 12 months

Secondary Outcomes

Patient-reported Outcomes Measures (PROMs)

Urinary symptoms by filling up International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) which is a questionnaire intended to assess female storage, voiding and incontinence symptoms. Lower scores are typically associated with reduced symptom severity.

Time frame: 0; 3 and 12 months

Patient-reported Outcomes Measures (PROMs)

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.

Time frame: 0; 3 and 12 months

Quality of life measures

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.

Time frame: 0; 3 and 12 months

Central Contacts

Akshaya Mariadassou

CONTACT

+331 84 60 48 25 a.mariadassou@stimuli-technology.com

Sarah Todeschini

CONTACT

+331 84 60 48 25 s.todeschini@stimuli-technology.com

Data from ClinicalTrials.gov

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