Tensi+ European Registry
ConditionOveractive Bladder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorStimuli Technology
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Patients suffering from idiopathic or neurological overactive bladder
Disqualifiers
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;
Trial population
Age ≥ 18 years Overactive bladder symptoms
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Tensi+
DeviceTensi+ (Stimuli Technology, Boulogne Billancourt, France) is a newly released, medical transcutaneous-posterior tibial nerve stimulation (TC-pTNS) device marketed for overactive bladder (OAB) management.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 months2
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 months3
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 monthsOther outcomes
1
Patient-reported Outcomes Measures (PROMs)
By filling up International Consultation on Incontinence Questionnaire - Bowel (ICIQ-B) which is a questionnaire for evaluating symptoms of anal incontinence. Lower scores are typically associated with reduced symptom severity.
Time frame
0; 3 and 12 months2
Evaluation of voiding frequency
Evaluation of daytime voiding frequency averaged over three days from bladder diary entries
Time frame
0; 3 and 12 months3
Evaluation of urgency
Evaluation of daily urgency episodes averaged over three days from bladder diary entries
Time frame
0; 3 and 12 months4
Evaluation of nocturia
Evaluation of nocturia episodes averaged over three days from bladder diary entries
Time frame
0; 3 and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov