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| Name | Class |
|---|---|
| Stanford University | OTHER |
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This pilot clinical study, which focuses on feasibility and proof-of-principle, will be conducted in 11 female subjects (55-100 years old) with UI. Subjects will use the device three times a week for 8 weeks and complete 3-day "voiding diaries" to record instances of UI episodes and OAB quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TENS Treatment Arm | Experimental | This study is an early feasibility study which will be treating all patients at least 3 times per week, for 8 weeks, using the device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TENS | Device | Transcutaneous electrical nerve stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Urge Incontinence Episodes | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Micturitions Per Day | Mean number of urinary voids per day (taken over a 3-day period) | Baseline and 8 weeks |
| Change in Health-related Quality of Life (HRQL) | Change in incontinence health-related quality of life (HRQL) scores compared to pre-treatment. The survey consists of 13 questions that can be scored from 1 to 6. Lower scores correspond with better quality of life. The lowest score possible is 13 and the highest is 78. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Palo Alto | California | 94304 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | TENS Treatment Arm | This study is an early feasibility study which will be treating all patients at least 3 times per week, for 8 weeks, using the device. TENS: Transcutaneous electrical nerve stimulation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TENS Treatment Arm | This study is an early feasibility study which will be treating all patients at least 3 times per week, for 8 weeks, using the device. TENS: Transcutaneous electrical nerve stimulation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Urge Incontinence Episodes | Posted | Mean | Standard Deviation | UUI | Baseline and 8 weeks |
|
|
Through study completion, an average of 8 weeks for each for each participant
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TENS Treatment Arm | This study is an early feasibility study which will be treating all patients at least 3 times per week, for 8 weeks, using the device. TENS: Transcutaneous electrical nerve stimulation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Associate | TheraNova | 415-926-8616 | akrajcevska@theranova.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 7, 2019 | Dec 16, 2019 | Prot_SAP_000.pdf |
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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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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| Baseline and 8 weeks |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| UUI | Urge Incontinence Episodes | Mean | Standard Deviation | Episodes |
|
|
| Secondary | Change in Micturitions Per Day | Mean number of urinary voids per day (taken over a 3-day period) | Posted | Mean | Standard Deviation | voids per day | Baseline and 8 weeks |
|
|
|
| Secondary | Change in Health-related Quality of Life (HRQL) | Change in incontinence health-related quality of life (HRQL) scores compared to pre-treatment. The survey consists of 13 questions that can be scored from 1 to 6. Lower scores correspond with better quality of life. The lowest score possible is 13 and the highest is 78. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 8 weeks |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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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 |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |