N/A
Completed N=6
A Study to Measure the Degree and Effectiveness of the Various vSculpt Operating Modes
sexual dysfunction · Stress Incontinence
Source: ClinicalTrials.gov NCT02856490 ↗
Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Change in Blood Flow as Measured by Temperature Change in the Genitalia Using Thermography Technology — -0.5; 1.8; -0.3; -0.2 Celsius degree
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Blood Flow as Measured by Temperature Change in the Genitalia Using Thermography Technology |
-0.5; 1.8; -0.3; -0.2; 0; -0.8 | — |
| SECONDARY Patient Quality of Life as Measured by Female Sexual Function Index (FSFI) Scores at Baseline and 30 Days Post Treatment. |
13.9; 21.6; 22.7; 19.0; 29.6; 22.3 | — |
| SECONDARY Patient Quality of Life as Measured by Female Sexual Distress Scores (FSDS) at Baseline and 30 Days Post Treatment. |
25.5; 22.0; 11.0; 20.0; 19.5; 5.0 | — |
| SECONDARY Patient Quality of Life as Measured by the Urogenital Distress Inventory, Short Form (UDI-6) |
30.6; 72.2; 47.2; 33.3; 41.7; 36.1 | — |
| SECONDARY Patient Quality of Life as Measured by the Incontinence Impact Questionnaire, Short Form (IIQ-7) |
9.5; 47.6; 14.3; 9.5; 40.5; 2.4 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02856490). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.