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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tensi+ | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective improvement | The Patient Global Impression of Improvement (PGI-I) uses a 7-point scale, where post-treatment condition is rated as follows:
For analysis, patients with a PGI-I score of 1, 2, or 3 are typically considered responders, reflecting meaningful improvement. | 3 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0; 3 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0; 3 and 12 months |
| Evaluation of voiding frequency |
Inclusion Criteria:
Exclusion Criteria:
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Age ≥ 18 years Overactive bladder symptoms
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HFME - Hospices Civils de Lyon | Recruiting | Bron | 69500 | France |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 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. | 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. | 0; 3 and 12 months |
Evaluation of daytime voiding frequency averaged over three days from bladder diary entries |
| 0; 3 and 12 months |
| Evaluation of urgency | Evaluation of daily urgency episodes averaged over three days from bladder diary entries | 0; 3 and 12 months |
| Evaluation of nocturia | Evaluation of nocturia episodes averaged over three days from bladder diary entries | 0; 3 and 12 months |
| Evaluation of urgency urinary incontinence | Evaluation of urgency urinary incontinence episodes averaged over three days from bladder diary entries | 0; 3 and 12 months |
| Evaluation of adverse events | 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. | 3 and 12 months |
| CHU de Rennes | Recruiting | Rennes | 35033 | France |
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| CHU de Rennes | Recruiting | Rennes | 35033 | France |
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| CHU de Rouen - Hôpital Charles Nicolle | Recruiting | Rouen | 76031 | France |
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| Nuova Villa Esther | Not yet recruiting | Avellino | 83100 | Italy |
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| Azienda Ospedaliero-Universitaria Careggi | Not yet recruiting | Florence | 50139 | Italy |
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| Hesperia Hospital | Not yet recruiting | Modena | 41125 | Italy |
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| Santa Maria la Gruccia Hospital | Not yet recruiting | Montevarchi | 52025 | Italy |
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| Policlinico Tor Vergata | Not yet recruiting | Roma | 00133 | Italy |
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| Casa di Cura Villa Stuart | Not yet recruiting | Roma | 00135 | Italy |
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| Villa Salaria Hospital | Not yet recruiting | Roma | 00139 | Italy |
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| Azienda Ospedaliero Universitaria Sant'Andrea | Not yet recruiting | Roma | 00189 | Italy |
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| Azienda Ospedaliero Universitaria Sant'Andrea | Not yet recruiting | Roma | 00189 | Italy |
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| Clinica Nuova Villa Claudia | Not yet recruiting | Roma | 00191 | Italy |
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| Bristol Urological Institute | Not yet recruiting | Bristol | BS10 5NB | United Kingdom |
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| Addenbrooke's Hospital, Cambridge University Hospital Trust | Not yet recruiting | Cambridge | CB22 0QQ | United Kingdom |
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| University College Hospital London | Not yet recruiting | London | NW1 2BU | United Kingdom |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |