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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
San Diego Sexual Medicine
San Diego, California, United States
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.
Time frame: Pre and post treatment at baseline and pre and post treatment at day 30
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.
Time frame: Baseline and 30 days
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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline and 30 days