Trial Outcomes & Findings for A Study to Measure the Degree and Effectiveness of the Various vSculpt Operating Modes (NCT NCT02856490)
NCT ID: NCT02856490
Last Updated: 2021-11-24
Results Overview
The primary outcomes assessed will be change in blood flow as measured by temperature change in Celsius in the genitalia using thermography technology.
Recruitment status
COMPLETED
Target enrollment
6 participants
Primary outcome timeframe
Pre and post treatment at baseline and pre and post treatment at day 30
Results posted on
2021-11-24
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
InTone Device
InTone genital device using electric muscle stimulation only.
InTone: A genital device using electric muscle stimulation to treat incontinence.
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Measure the Degree and Effectiveness of the Various vSculpt Operating Modes
Baseline characteristics by cohort
| Measure |
vSculpt With Vibration Only
n=2 Participants
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.
|
vSculpt With Vibration and Light
n=2 Participants
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.
|
InTone Device
n=2 Participants
InTone genital device using electric muscle stimulation only.
InTone: A genital device using electric muscle stimulation to treat incontinence.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Pre and post treatment at baseline and pre and post treatment at day 30The primary outcomes assessed will be change in blood flow as measured by temperature change in Celsius in the genitalia using thermography technology.
Outcome measures
| Measure |
vSculpt With Vibration Only
n=2 Participants
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.
|
vSculpt With Vibration and Light
n=2 Participants
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.
|
InTone Device
n=2 Participants
InTone genital device using electric muscle stimulation only.
InTone: A genital device using electric muscle stimulation to treat incontinence.
|
|---|---|---|---|
|
Change in Blood Flow as Measured by Temperature Change in the Genitalia Using Thermography Technology
Baseline
|
-0.5 Celsius degree
Standard Deviation 0.7
|
1.8 Celsius degree
Standard Deviation 1.3
|
-0.3 Celsius degree
Standard Deviation 0.7
|
|
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
|
0 Celsius degree
Standard Deviation 2.0
|
-0.8 Celsius degree
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Baseline and 30 daysChange 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.
Outcome measures
| Measure |
vSculpt With Vibration Only
n=2 Participants
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.
|
vSculpt With Vibration and Light
n=2 Participants
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.
|
InTone Device
n=2 Participants
InTone genital device using electric muscle stimulation only.
InTone: A genital device using electric muscle stimulation to treat incontinence.
|
|---|---|---|---|
|
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
|
21.6 units on a scale
Standard Deviation 6.0
|
22.7 units on a scale
Standard Deviation 8.3
|
|
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
|
29.6 units on a scale
Standard Deviation 2.3
|
22.3 units on a scale
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: Baseline and 30 daysChange 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.
Outcome measures
| Measure |
vSculpt With Vibration Only
n=2 Participants
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.
|
vSculpt With Vibration and Light
n=2 Participants
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.
|
InTone Device
n=2 Participants
InTone genital device using electric muscle stimulation only.
InTone: 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.
Baseline
|
25.5 units on a scale
Standard Deviation 12.0
|
22.0 units on a scale
Standard Deviation 5.7
|
11.0 units on a scale
Standard Deviation 5.7
|
|
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
|
19.5 units on a scale
Standard Deviation 2.1
|
5.0 units on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Baseline and 30 daysChange 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.
Outcome measures
| Measure |
vSculpt With Vibration Only
n=2 Participants
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.
|
vSculpt With Vibration and Light
n=2 Participants
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.
|
InTone Device
n=2 Participants
InTone genital device using electric muscle stimulation only.
InTone: A genital device using electric muscle stimulation to treat incontinence.
|
|---|---|---|---|
|
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
|
72.2 units on a scale
Standard Deviation 15.7
|
47.2 units on a scale
Standard Deviation 27.5
|
|
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
|
41.7 units on a scale
Standard Deviation 19.6
|
36.1 units on a scale
Standard Deviation 19.6
|
SECONDARY outcome
Timeframe: Baseline and 30 daysChange 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.
Outcome measures
| Measure |
vSculpt With Vibration Only
n=2 Participants
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.
|
vSculpt With Vibration and Light
n=2 Participants
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.
|
InTone Device
n=2 Participants
InTone genital device using electric muscle stimulation only.
InTone: A genital device using electric muscle stimulation to treat incontinence.
|
|---|---|---|---|
|
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
|
47.6 units on a scale
Standard Deviation 26.9
|
14.3 units on a scale
Standard Deviation 20.2
|
|
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
|
40.5 units on a scale
Standard Deviation 43.8
|
2.4 units on a scale
Standard Deviation 3.4
|
Adverse Events
vSculpt With Vibration Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
vSculpt With Vibration and Light
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
InTone Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER