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The purpose of the study is to evaluate the safety and effectiveness of the Tensi+ device using Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS) for treating patients suffering from OAB symptoms urinary frequency, urgency, with or without urge urinary incontinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tensi+ device to be delivered for use by patient | Active Comparator |
| |
| Identical Tensi+ Sham device to be delivered for use by patient | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tensi+ | Device | Transcutaneous Tibial Nerve Stimulation |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment success | Percentage of responders in urgency events, where a responder is defined as a subject that either achieves a 50% or greater reduction, from baseline to Week 12, in total urgency events per day, or returns to normal (0 events per day) at Week 12. This endpoint will be evaluated through 3-day bladder diaries. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of urinary voids | Percentage of responders in urinary frequency, where a responder is defined as a subject that either achieves a 30% or greater reduction, from baseline to Week 12, in total urinary frequency per day, or returns to normal | 12 weeks |
| Urge urinary incontinence |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
|---|---|---|---|---|---|---|
| Cedars-Sinai | Beverly Hills | California | 90211 | United States |
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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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Percentage of responders in urge urinary incontinence, where a responder is defined as a subject that either achieves a 30% or greater reduction, from baseline to Week 12, in total urinary frequency per day, or returns to normal (0 events per day) |
| 12 weeks |
| Overall Responder Rate Across OAB Symptoms | Overall Responder rate defined as the percentage of responders who meet at least the responder criteria in one of the 3 symptoms of OAB, from baseline to Week 12 (urgency, frequency and UUI) from baseline | 12 weeks |
| Quality of life measures | Measured using the OAB-q Short Form (SF) questionnaire, which includes 19 questions scored from 1 ("none of the time") to 6 ("all of the time"). The total score ranges from 19 (best QOL) to 114 (worst QOL). A decrease in score from baseline to Week 12 indicates an improvement in quality of life. | 12 weeks |
| Endurance of effect | Maintenance of responder status from the primary endpoint (Week 12) through the last follow-up visit without relapse (Week 24), indicating a sustained treatment effect until the end-of-study visit. | 24 weeks |
| NYU Langone Health | New York | New York | 10017 | United States |
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| Toronto Western Hospital | Toronto | Canada |
|
| 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 |