Sexual Dysfunction, Stress Incontinence
Conditions
Brief summary
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
Detailed description
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.
Interventions
DEVICEvSculpt
A genital vibration device that operates in two modes, vibration only or vibration and light, to help tone and tighten pelvic floor muscles.
DEVICEInTone
A genital device using electric muscle stimulation to treat incontinence.
Sponsors
Joylux, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
48 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Study participants will be female * Female participants who are capable of giving informed consent * Female participants who are menopausal who have not had a menses within one year, and are within the ages of 48 and 60 * Female participants who have had one or more vaginal births * Female participants who are currently engaged in vaginal sexual intercourse with a partner * Female participants who are presently experiencing bladder control issues either leakage, frequency or urgency * Female participants who are presently experiencing pain during sexual intercourse
Exclusion criteria
* Female participants shall not have an active sexually transmitted disease and/or infection * Female participants who are actively undergoing chemotherapy * Female participants who are currently taking any cancer-related drugs * Female participants who are breastfeeding or lactating * Female participants who have a medical history of neurological disorders (e.g., multiple sclerosis, Parkinson's disease) * Female participants with an active urinary tract infection (UTI) * Female participants with active bladder stones * Female participants with active bladder tumor(s) * Females with prior laser or vaginal rejuvenation surgeries or treatments * Females with a medical history of vaginal cancer or radiation or surgery with exception of related to childbirth * Females with prior non-invasive treatments (estrogen cream) or pelvic floor physical therapy for the vaginal area/ pelvic floor in the past six month * Females with a physical disability precluding her from holding a lithotomy for an hour * Females who are homeless
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Blood Flow as Measured by Temperature Change in the Genitalia Using Thermography Technology | Pre and post treatment at baseline and pre and post treatment at day 30 | The primary outcomes assessed will be change in blood flow as measured by temperature change in Celsius in the genitalia using thermography technology. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Quality of Life as Measured by Female Sexual Function Index (FSFI) Scores at Baseline and 30 Days Post Treatment. | Baseline and 30 days | 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. |
| Patient Quality of Life as Measured by Female Sexual Distress Scores (FSDS) at Baseline and 30 Days Post Treatment. | Baseline and 30 days | 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. |
| Patient Quality of Life as Measured by the Urogenital Distress Inventory, Short Form (UDI-6) | Baseline and 30 days | 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. |
| Patient Quality of Life as Measured by the Incontinence Impact Questionnaire, Short Form (IIQ-7) | Baseline and 30 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| 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. | 2 |
| InTone Device InTone genital device using electric muscle stimulation only.
InTone: A genital device using electric muscle stimulation to treat incontinence. | 2 |
| Total | 6 |
Baseline characteristics
| Characteristic | vSculpt With Vibration Only | vSculpt With Vibration and Light | InTone Device | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants | 2 Participants | 6 Participants |
| Region of Enrollment United States | 2 participants | 2 participants | 2 participants | 6 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 0 / 2 | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 | 0 / 2 |
Outcome results
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.
Time frame: Pre and post treatment at baseline and pre and post treatment at day 30
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| vSculpt With Vibration Only | Change in Blood Flow as Measured by Temperature Change in the Genitalia Using Thermography Technology | Baseline | -0.5 Celsius degree | Standard Deviation 0.7 |
| vSculpt With Vibration Only | Change in Blood Flow as Measured by Temperature Change in the Genitalia Using Thermography Technology | 30 Days Post Treatment | -0.2 Celsius degree | Standard Deviation 0.4 |
| vSculpt With Vibration and Light | Change in Blood Flow as Measured by Temperature Change in the Genitalia Using Thermography Technology | Baseline | 1.8 Celsius degree | Standard Deviation 1.3 |
| vSculpt With Vibration and Light | Change in Blood Flow as Measured by Temperature Change in the Genitalia Using Thermography Technology | 30 Days Post Treatment | 0 Celsius degree | Standard Deviation 2 |
| InTone Device | Change in Blood Flow as Measured by Temperature Change in the Genitalia Using Thermography Technology | Baseline | -0.3 Celsius degree | Standard Deviation 0.7 |
| InTone Device | Change in Blood Flow as Measured by Temperature Change in the Genitalia Using Thermography Technology | 30 Days Post Treatment | -0.8 Celsius degree | Standard Deviation 0.1 |
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.
Time frame: Baseline and 30 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| vSculpt With Vibration Only | Patient Quality of Life as Measured by Female Sexual Distress Scores (FSDS) at Baseline and 30 Days Post Treatment. | Baseline | 25.5 units on a scale | Standard Deviation 12 |
| vSculpt With Vibration Only | Patient Quality of Life as Measured by Female Sexual Distress Scores (FSDS) at Baseline and 30 Days Post Treatment. | 30 Days Post | 20.0 units on a scale | Standard Deviation 5.7 |
| vSculpt With Vibration and Light | Patient Quality of Life as Measured by Female Sexual Distress Scores (FSDS) at Baseline and 30 Days Post Treatment. | Baseline | 22.0 units on a scale | Standard Deviation 5.7 |
| vSculpt With Vibration and Light | Patient Quality of Life as Measured by Female Sexual Distress Scores (FSDS) at Baseline and 30 Days Post Treatment. | 30 Days Post | 19.5 units on a scale | Standard Deviation 2.1 |
| InTone Device | Patient Quality of Life as Measured by Female Sexual Distress Scores (FSDS) at Baseline and 30 Days Post Treatment. | Baseline | 11.0 units on a scale | Standard Deviation 5.7 |
| InTone Device | Patient Quality of Life as Measured by Female Sexual Distress Scores (FSDS) at Baseline and 30 Days Post Treatment. | 30 Days Post | 5.0 units on a scale | Standard Deviation 2.8 |
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.
Time frame: Baseline and 30 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| vSculpt With Vibration Only | Patient Quality of Life as Measured by Female Sexual Function Index (FSFI) Scores at Baseline and 30 Days Post Treatment. | Baseline | 13.9 units on a scale | Standard Deviation 1.1 |
| vSculpt With Vibration Only | Patient Quality of Life as Measured by Female Sexual Function Index (FSFI) Scores at Baseline and 30 Days Post Treatment. | 30 Days Post | 19.0 units on a scale | Standard Deviation 5.7 |
| vSculpt With Vibration and Light | Patient Quality of Life as Measured by Female Sexual Function Index (FSFI) Scores at Baseline and 30 Days Post Treatment. | Baseline | 21.6 units on a scale | Standard Deviation 6 |
| vSculpt With Vibration and Light | Patient Quality of Life as Measured by Female Sexual Function Index (FSFI) Scores at Baseline and 30 Days Post Treatment. | 30 Days Post | 29.6 units on a scale | Standard Deviation 2.3 |
| InTone Device | Patient Quality of Life as Measured by Female Sexual Function Index (FSFI) Scores at Baseline and 30 Days Post Treatment. | Baseline | 22.7 units on a scale | Standard Deviation 8.3 |
| InTone Device | Patient Quality of Life as Measured by Female Sexual Function Index (FSFI) Scores at Baseline and 30 Days Post Treatment. | 30 Days Post | 22.3 units on a scale | Standard Deviation 5.5 |
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.
Time frame: Baseline and 30 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| vSculpt With Vibration Only | Patient Quality of Life as Measured by the Incontinence Impact Questionnaire, Short Form (IIQ-7) | Baseline | 9.5 units on a scale | Standard Deviation 13.5 |
| vSculpt With Vibration Only | Patient Quality of Life as Measured by the Incontinence Impact Questionnaire, Short Form (IIQ-7) | 30 Days Post | 9.5 units on a scale | Standard Deviation 6.7 |
| vSculpt With Vibration and Light | Patient Quality of Life as Measured by the Incontinence Impact Questionnaire, Short Form (IIQ-7) | Baseline | 47.6 units on a scale | Standard Deviation 26.9 |
| vSculpt With Vibration and Light | Patient Quality of Life as Measured by the Incontinence Impact Questionnaire, Short Form (IIQ-7) | 30 Days Post | 40.5 units on a scale | Standard Deviation 43.8 |
| InTone Device | Patient Quality of Life as Measured by the Incontinence Impact Questionnaire, Short Form (IIQ-7) | Baseline | 14.3 units on a scale | Standard Deviation 20.2 |
| InTone Device | Patient Quality of Life as Measured by the Incontinence Impact Questionnaire, Short Form (IIQ-7) | 30 Days Post | 2.4 units on a scale | Standard Deviation 3.4 |
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.
Time frame: Baseline and 30 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| vSculpt With Vibration Only | Patient Quality of Life as Measured by the Urogenital Distress Inventory, Short Form (UDI-6) | Baseline | 30.6 units on a scale | Standard Deviation 3.9 |
| vSculpt With Vibration Only | Patient Quality of Life as Measured by the Urogenital Distress Inventory, Short Form (UDI-6) | 30 Days Post | 33.3 units on a scale | Standard Deviation 7.9 |
| vSculpt With Vibration and Light | Patient Quality of Life as Measured by the Urogenital Distress Inventory, Short Form (UDI-6) | Baseline | 72.2 units on a scale | Standard Deviation 15.7 |
| vSculpt With Vibration and Light | Patient Quality of Life as Measured by the Urogenital Distress Inventory, Short Form (UDI-6) | 30 Days Post | 41.7 units on a scale | Standard Deviation 19.6 |
| InTone Device | Patient Quality of Life as Measured by the Urogenital Distress Inventory, Short Form (UDI-6) | Baseline | 47.2 units on a scale | Standard Deviation 27.5 |
| InTone Device | Patient Quality of Life as Measured by the Urogenital Distress Inventory, Short Form (UDI-6) | 30 Days Post | 36.1 units on a scale | Standard Deviation 19.6 |