Overactive Bladder
Conditions
Keywords
Urology, TENS, Overactive bladder
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.
Interventions
DEVICETensi+
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.
Sponsors
Stimuli Technology
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported Outcomes Measures (PROMs) | 0; 3 and 12 months | 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of nocturia | 0; 3 and 12 months | Evaluation of nocturia episodes averaged over three days from bladder diary entries |
| Patient-reported Outcomes Measures (PROMs) | 0; 3 and 12 months | 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. |
| Evaluation of adverse events | 3 and 12 months | Patients will be asked whether they experienced any adverse events during treatment. Patient responses will be collected and described qualitatively, enabling the identification of the types of adverse events reported as well as the frequency of their occurrence. |
| Evaluation of urgency urinary incontinence | 0; 3 and 12 months | Evaluation of urgency urinary incontinence episodes averaged over three days from bladder diary entries |
| Evaluation of voiding frequency | 0; 3 and 12 months | Evaluation of daytime voiding frequency averaged over three days from bladder diary entries |
| Evaluation of urgency | 0; 3 and 12 months | Evaluation of daily urgency episodes averaged over three days from bladder diary entries |
Countries
France, Italy, United Kingdom
Contacts
Primary ContactAkshaya Mariadassou
Backup ContactSarah Todeschini
Outcome results
None listed