N/A
N=47
Radiofrequency and Hybrid Fractional Laser for Vaginal Rejuvenation
Vaginal Atrophy
Bottom Line
View on ClinicalTrials.gov: NCT03316950 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Vulvovaginal Symptoms Questionnaire — 8; 7.88; 5.93; 5.93 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- IntraGen RF (Device); DiVA (Device); Placebo (DIVA/IntraGen combined) (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vulvovaginal Symptoms Questionnaire |
8; 7.88; 5.93; 5.93; 3.22; 5 | — |
| PRIMARY Vaginal Laxity Questionnaire |
3.57; 3.67; 2.79; 2.79; 4.44; 3.75 | — |
| SECONDARY Perceived Changes in Vaginal Laxity as Measured by Zimmern Probe at 3 Months Post Treatment |
0.44; 0.78; 0.7; 0.36 | — |
| SECONDARY Perceived Changes in Vaginal Laxity as Measured by Zimmern Probe at 6 Months Post Treatment |
— | — |
| SECONDARY Urogenital Distress Short Form (UDI-6) |
36.11; 34.38; 28.15; 28.15; 25.65; 41.15 | — |
| SECONDARY Incontinence Impact Questionnaire Short Form (IIQ-7) |
22.75; 22.02; 10.2; 10.2; 7.41; 11.31 | — |
| SECONDARY Female Sexual Function Index (FSFI) |
14.96; 15.69; 15.98; 16.09; 21.38; 18.73 | — |
| SECONDARY Gene Expression- Col1A1 as Measured by Fold Change |
0.67; 0.48; 1; 0.95 | — |
| SECONDARY Gene Expression- Col3A1 as Measured by Fold Change |
0.95; 0.82; 1; 1.23 | — |
| SECONDARY Gene Expression- ELN as Measured by Fold Change |
0.40; 0.33; 1; 0.79 | — |
| SECONDARY Gene Expression- LOX as Measured by Fold Change |
2.72; 0.75; 1; 0.95 | — |
Summary
This is a single-center, randomized, prospective study designed to evaluate the efficacy of radiofrequency and hybrid fractional laser for vaginal rejuvenation. 120 subjects will be screened with 100 undergoing a three-part treatment of the vulvovaginal area IntraGen RF unit, IntraGen RF unit placebo, DiVa HFL unit, or DiVa HFL unit placebo. These treatments will be spaced one month apart and last about 25 minutes each. Each subject will be screened, undergo testing at baseline, and will be followed conservatively with no further therapy until they reach 6 months after the initiation of the designated treatment. At that time, all subjects will undergo subjective and objective testing. Those in the treatment group will be followed to 9 and 12 months after the initiation of treatment with appropriate analysis. Those in the placebo group will be provided a three-part treatment of the vulvovaginal area with the IntraGen RF unit and DiVA HFL unit. These treatments will be spaced one month apart and last about 25 minutes each. Six months after receiving three treatments of the dual therapy these patients will undergo subjective and objective testing. The primary outcome measure is improvement in vulvovaginal symptoms measured by the validated Vulvovaginal Symptoms Questionnaire. Data obtained from each investigation will be recorded in a password-protected digital spreadsheet, REDCap database and descriptive statistics will be obtained.
Eligibility Criteria
Inclusion Criteria
- Women should be between 40 and 65 years of age
- Women should be post-menopausal
- Women should be amenorrheic for at least 12 months
- Postmenopausal women presenting with one or more of the following:
- Vulvar itching
- Vulvar burning or stinging
- Vulvar pain
- Vulvar irritation
- Vulvar dryness
- Discharge from subject's vulva or vagina
- Odor from subject's vulva or vagina
Exclusion Criteria
- Unable to commit to future appointments within one year
- Planning on moving away from Dallas within one year
- History of other energy-based vaginal therapy within one year
- Vaginal hormone replacement therapy must have a one month washout period prior to treatment and discontinued use for duration of study, systemic replacement is not excluded
- Prior labiaplasty, or vaginal injections of fat or fillers within 6 months
- Prior anti-incontinence surgery in the last 12 months
- Urinary incontinence requiring more than 2 pads/day
- Clinically significant pelvic organ prolapse (POP)
- Urinary tract infection in the past 3 months
- Unstable diabetes
- Ongoing chemotherapy
- Immunodeficiency status (steroid intake, ongoing chemotherapy)
- Diffuse pain syndrome or chronic pain requiring daily narcotics
- Chronic vaginitis including bacterial vaginosis, HPV, herpes, or other active STI
- Recent abnormal Papanicolaou test result
- Recent abnormal pelvic exam (i.e. concerning lesions)
- Vulvar dermatologic pathology requiring local steroid use
- Undiagnosed abnormal genital bleeding
- If less than two years postmenopausal, not using a medically approved method of contraception (i.e. oral, transdermal, implanted contraceptives, intrauterine device, diaphragm, condom, etc.)
- Pregnancy
- History of genital fistula or a thin rectovaginal septum
- Uncontrolled psychiatric conditions (well-controlled depression/anxiety is not excluded)
- Body Mass Index > 35
- Actively participating in or planning on participating in pelvic floor muscle strengthening exercise
- Presence of pacemaker, AICD, or other electrical health maintenance device
Data sourced from ClinicalTrials.gov (NCT03316950). 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.