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A pilot study to determine the degree and effectiveness of the various modes of vSculpt, an over-the-counter "OTC" medical device, on enhanced genital blood flow and improvement in quality of life in menopausal women who suffer sexual dysfunction and stress incontinence
The primary aim of this study is to determine the degree and effectiveness of the various modes of vSculpt on enhanced genital blood flow with menopausal women who experience sexual dysfunction and stress incontinence as measured by temperature change in the genitalia immediately after initial and final treatment and an improvement in quality of life after using the vSculpt device over the course of four weeks. The secondary aim is to compare the differences in genital blood flow and improvement in quality of life of vSculpt's various modes against Intone, another over-the-counter "OTC" medical device that utilizes a different technology to treat stress incontinence and improve sexual dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vSculpt with Vibration Only | Active Comparator | vSculpt genital device used in vibration mode only. |
|
| vSculpt with Vibration and Light | Active Comparator | vSculpt genital device used in vibration and light mode. |
|
| InTone Device | Active Comparator | InTone genital device using electric muscle stimulation only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vSculpt | Device | A genital vibration device that operates in two modes, vibration only or vibration and light, to help tone and tighten pelvic floor muscles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood Flow as Measured by Temperature Change in the Genitalia Using Thermography Technology | The primary outcomes assessed will be change in blood flow as measured by temperature change in Celsius in the genitalia using thermography technology. | Pre and post treatment at baseline and pre and post treatment at day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Quality of Life as Measured by Female Sexual Function Index (FSFI) Scores at Baseline and 30 Days Post Treatment. | Change in patient quality of life as measured by an improvement in Female Sexual Function Index (FSFI) scores at baseline and 30 days post treatment. The range being from 2 (minimum) to 36 (maximum), with maximum being better. | Baseline and 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego Sexual Medicine | San Diego | California | 92120 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | vSculpt With Vibration Only | vSculpt genital device used in vibration mode only. vSculpt: A genital vibration device that operates in two modes, vibration only or vibration and light, to help tone and tighten pelvic floor muscles. |
| FG001 | vSculpt With Vibration and Light | vSculpt genital device used in vibration and light mode. vSculpt: A genital vibration device that operates in two modes, vibration only or vibration and light, to help tone and tighten pelvic floor muscles. |
| FG002 | InTone Device | InTone genital device using electric muscle stimulation only. InTone: A genital device using electric muscle stimulation to treat incontinence. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | vSculpt With Vibration Only | vSculpt genital device used in vibration mode only. vSculpt: A genital vibration device that operates in two modes, vibration only or vibration and light, to help tone and tighten pelvic floor muscles. |
| BG001 | vSculpt With Vibration and Light |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Blood Flow as Measured by Temperature Change in the Genitalia Using Thermography Technology | The primary outcomes assessed will be change in blood flow as measured by temperature change in Celsius in the genitalia using thermography technology. | Posted | Mean | Standard Deviation | Celsius degree | Pre and post treatment at baseline and pre and post treatment at day 30 |
|
30 Days
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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 | vSculpt With Vibration Only | vSculpt genital device used in vibration mode only. vSculpt: A genital vibration device that operates in two modes, vibration only or vibration and light, to help tone and tighten pelvic floor muscles. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Colette Courtion | Joylux | 206.219.6444 | sophia@joylux.com |
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| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
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| InTone | Device | A genital device using electric muscle stimulation to treat incontinence. |
|
|
| Patient Quality of Life as Measured by Female Sexual Distress Scores (FSDS) at Baseline and 30 Days Post Treatment. | Change in patient quality of life as measured by an improvement in Female Sexual Distress Scores (FSDS) at baseline and 30 days post treatment. The range being from 0 (minimum) to 52 (maximum), with minimum being better. | Baseline and 30 days |
| Patient Quality of Life as Measured by the Urogenital Distress Inventory, Short Form (UDI-6) | Change in patient quality of life as measured by an improvement in Urogenital Distress Inventory, Short Form (UDI-6) scores. The range being from 0 (minimum) to 100 (maximum), with minimum being better. | Baseline and 30 days |
| Patient Quality of Life as Measured by the Incontinence Impact Questionnaire, Short Form (IIQ-7) | Change in patient quality of life as measured by an improvement in Incontinence Impact Questionnaire, Short Form (IIQ-7) scores. The range being from 0 (minimum) to 100 (maximum), with minimum being better. | Baseline and 30 days |
vSculpt genital device used in vibration and light mode. vSculpt: A genital vibration device that operates in two modes, vibration only or vibration and light, to help tone and tighten pelvic floor muscles. |
| BG002 | InTone Device | InTone genital device using electric muscle stimulation only. InTone: A genital device using electric muscle stimulation to treat incontinence. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | InTone Device | InTone genital device using electric muscle stimulation only. InTone: A genital device using electric muscle stimulation to treat incontinence. |
|
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| Secondary | Patient Quality of Life as Measured by Female Sexual Function Index (FSFI) Scores at Baseline and 30 Days Post Treatment. | Change in patient quality of life as measured by an improvement in Female Sexual Function Index (FSFI) scores at baseline and 30 days post treatment. The range being from 2 (minimum) to 36 (maximum), with maximum being better. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 30 days |
|
|
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| Secondary | Patient Quality of Life as Measured by Female Sexual Distress Scores (FSDS) at Baseline and 30 Days Post Treatment. | Change in patient quality of life as measured by an improvement in Female Sexual Distress Scores (FSDS) at baseline and 30 days post treatment. The range being from 0 (minimum) to 52 (maximum), with minimum being better. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 30 days |
|
|
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| Secondary | Patient Quality of Life as Measured by the Urogenital Distress Inventory, Short Form (UDI-6) | Change in patient quality of life as measured by an improvement in Urogenital Distress Inventory, Short Form (UDI-6) scores. The range being from 0 (minimum) to 100 (maximum), with minimum being better. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 30 days |
|
|
|
| Secondary | Patient Quality of Life as Measured by the Incontinence Impact Questionnaire, Short Form (IIQ-7) | Change in patient quality of life as measured by an improvement in Incontinence Impact Questionnaire, Short Form (IIQ-7) scores. The range being from 0 (minimum) to 100 (maximum), with minimum being better. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 30 days |
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|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | vSculpt With Vibration and Light | vSculpt genital device used in vibration and light mode. vSculpt: A genital vibration device that operates in two modes, vibration only or vibration and light, to help tone and tighten pelvic floor muscles. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG002 | InTone Device | InTone genital device using electric muscle stimulation only. InTone: A genital device using electric muscle stimulation to treat incontinence. | 0 | 2 | 0 | 2 | 0 | 2 |
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| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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