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The objective of this trial is to evaluate the safety and efficacy of the combined FormaV and VTone Applicators for Symptoms of Mixed Urinary Incontinence.
Eligible subjects will receive 3 treatments(every 2 weeks) with the FormaV and VTone Applicators according to the study protocol.
The subject will return for 3 follow-up visits: 4 weeks (1M FU), 3 months follow up (3M FU), 6 months follow up (6M FU) after the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FormaV and VTone | Device | Eligible subjects will receive 3 treatments(every 2 weeks) with the FormaV and VTone Applicators according to the study protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cough stress test | Change as measured by standardized cough stress test performed in standing position before treatment and 6 months after the treatment | Baseline through month 6 |
| Quality of Life (IQOL) Questionnaire | The effect of the treatment on urinary symptoms and quality of life by means of the Incontinence Quality of Life (IQOL) Questionnaire. | baseline through month 6 |
| Female Sexual Function Index questionnaire | The effect of the treatment on female sexual function by means of Female Sexual Function Index | baseline through month 6 |
| Urogenital Distress Inventory 6 Questionnaire | The effect of the treatment on urinary symptoms by means of Urogenital Distress Inventory 6 Questionnaire | baseline through month 6 |
| Medical, Epidemiologic, and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire | The effect of the treatment on urinary symptoms by means of Medical, Epidemiologic, and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire ( | baseline through month 6 |
| Patient Global Impression of Improvement (PGI), using a 5-point Likert scale | The rate of satisfaction of patients with treatment assessed by the Patient Global Impression of Improvement (PGI), using a 5-point Likert scale | month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Discomfort scale | A 10cm visual analog scale from 0 (no discomfort) to 10 (worst possible discomfort) to measure discomfort associated with probe insertion, and RF/EMS energy application at the treatment visit | post treatment |
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
7.5 Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Women's Care of the Lowcountry, PC | Bluffton | South Carolina | 29910 | United States | ||
| Lisa M Jukes MD |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Number, severity and type of any adverse event recorded throughout the course of the study.
| throughout the study |
| West Lake Hills |
| Texas |
| 78746 |
| United States |
| 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 |