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An open-label long-term evaluation of a novel intravaginal device in female patients experiencing sexual and bladder function issues.
To determine the long-term clinical efficacy of the vSculpt therapy on treating the pelvic floor area and vaginal tissue for females who experience bladder and sexual dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vSculpt, model #VS1100 | Experimental | A novel intravaginal device for females |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vSculpt | Device | Pelvic Floor Toning and Vaginal Rejuvenation Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Patient Quality of Life as Measured by Female Sexual Response Index | Improvement in patient quality of life as measured by an improvement in Female Sexual Function Index (FSFI) scores. | 365 days |
| Improvement in patient quality of life as measured by the Female Sexual Distress | Improvement in patient quality of life as measured by an improvement Female Sexual Distress Score (FSDS) scores. | 365 days |
| Improvement in patient quality of life as measured by the Urogenital Distress Inventory, Short Form (UDI-6) | Improvement in patient quality of life as measured by an improvement Urogenital Distress Inventory, Short Form (UDI-6) scores. | 365 days |
| Improvement in patient quality of life as measured by the Incontinence Impact Questionnaire, Short Form (IIQ-7) | Improvement in patient quality of life as measured by an improvement Incontinence Impact Questionnaire, Short Form (IIQ-7) scores. | 365 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah De La Torre, MD | Seattle OB/GYN Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Egrari Non Invasive Center | Bellevue | Washington | 98004 | United States | ||
| Seattle Obstetrics and Gynecology Group |
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| ID | Term |
|---|---|
| D059952 | Pelvic Floor Disorders |
| D012735 | Sexual Dysfunction, Physiological |
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011248 | Pregnancy Complications |
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| Seattle |
| Washington |
| 98104 |
| United States |
| D052801 | Male Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |