A Randomized, Placebo-Controlled Trial Evaluating Radiofrequency and Hybrid Fractional Laser for Vaginal Rejuvenation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Vulvovaginal Symptoms Questionnaire
Study Overview
Brief 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.
Detailed Description
Vaginal rejuvenation is a catch-all term of trendy procedures which claim to provide relief of many issues affecting women's health, ranging from postmenopausal vulvovaginal symptoms (i.e. dryness, burning, itching), stress urinary incontinence, sexual dysfunction or discomfort, vaginal laxity, and labial appearance, amongst others2,3. Several companies have emerged with non-invasive or minimally-invasive technologies to alleviate these conditions which operate by radiofrequency delivery (IntraGen by Jeisys), Hybrid Fractional Laser (diVa by Sciton), or fractional CO2 laser (Mona Lisa Touch by Cynosure and Femi Lift by Alma Laser)4.
All of these technologies work theoretically by remodeling extracellular matrix configuration. It is of important note that radiofrequency therapies are typically delivered at 45-55 degrees Celsius in the tissues whereas the laser based products heat up to 60-70 degrees Celsius5. It is believed that "neocollagenesis" may only start if the temperatures are high enough and that such changes in the collagen matrix of the vagina could lead to durable vaginal wall changes. Sciton's diVa is hybrid fractional laser with wavelengths of 2940 nm and 1470 nm for ablation and coagulation, respectively, to treat vaginal tissue6. It is not known whether the changes experienced by patients are due to the reconfiguration of the extracellular matrix (ECM) deep in the vaginal wall or related to the acute swelling and inflammatory processes that occur at the surface of the vagina after these rejuvenation procedures.
The early anecdotal success reported on some user websites might be attributable to surface changes that may not be lasting or to possibly more lasting deeper muscular vaginal wall changes, which may or may not be beneficial. Based on the answer to this first set of questions, we might possibly surmise how such changes will ultimately improve vaginal dryness and/or stress urinary incontinence complaints.
An overriding question and concern is: Assuming these treatments induce collagen changes in the vagina, is it safe to induce such changes? If changes occur, are they long lasting? Can it age the vagina instead of making it "younger"? What are the long-term effects of doing so? Is tissue tightening really scar formation that may be deleterious in the future? The histological, genetic and dynamic changes following vaginal rejuvenation have never been studied.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
IntraGen RF
Patients will undergo treatment with radiofrequency device, using the device's standard protocol. Patients will have 3 treatments space one month apart. Each treatment will be a total of 20 minutes for internal treatment only. Prior to treatment, the Zimmern probe will be used to measure vaginal wall elasticity and a 0.33mm biopsy will be taken. At each visit, the Zimmern probe will be used. Biopsies will be taken 3 months after final treatment.
Intervention: IntraGen RF (Device)
DiVA
Patients randomized into the DiVA treatment group will receive treatment per DiVA protocol. Patients will have a total of 3 treatments, space 1 month apart. Each treatment will last approximately 10 minutes. Prior to treatment, the Zimmern probe will be used to measure vaginal wall elasticity and a 0.33mm biopsy will be taken. At each visit, the Zimmern probe will be used. Biopsies will be taken 3 months after final treatment.
Intervention: DiVA (Device)
Placebo Arm
Patients randomized into the Placebo arm will include participants from the DiVa PlaceboGroup and IntraGen Placebo Group combined and will receive treatment based on the DiVA Sham and IntraGen Sham protocols.
DiVa Placebo: patients will undergo a three-part placebo treatment, spaced 1 month apart (+/- 10 days) of the vulvovaginal area. The vaginal HFL handpiece will be inserted into the vaginal canal but sub-therapeutic energy will not be delivered to the tissue.
IntraGen Placebo: patients will undergo a three-part placebo treatment, space 1 month apart (+/- 10 days) of the vulvovaginal area. This will be achieved through application of the probe, but with applying sub-therapeutic energy to the tissue.
Intervention: Placebo (DIVA/IntraGen combined) (Device)
Dual Treatment
Patients previously randomized into the DiVA Sham and IntraGen Sham groups will be placed in the Dual Treatment group. Patients will have a total of 3 dual treatments, spaced 1 month apart. Each treatment will last approximately 20 minutes. Prior to dual treatments, the Zimmern probe will be used to measure vaginal wall elasticity and a 0.33mm biopsy will be taken. At each visit, the Zimmern probe will be used. Biopsies will be taken at follow up visits.
Intervention: IntraGen RF (Device)
Dual Treatment
Patients previously randomized into the DiVA Sham and IntraGen Sham groups will be placed in the Dual Treatment group. Patients will have a total of 3 dual treatments, spaced 1 month apart. Each treatment will last approximately 20 minutes. Prior to dual treatments, the Zimmern probe will be used to measure vaginal wall elasticity and a 0.33mm biopsy will be taken. At each visit, the Zimmern probe will be used. Biopsies will be taken at follow up visits.
Intervention: DiVA (Device)
Outcomes
Primary Outcomes
Vulvovaginal Symptoms Questionnaire
Time Frame: Baseline, 3 Month Post- treatments and 6 Month Post Treatments
VSQ is a 21-item validated survey designed to assess postmenopausal quality-of-life parameters, namely vulvovaginal symptoms, emotions, life and sexual impact. Min: 0; Max: 21 Higher score would indicate greater number of symptoms.
Vaginal Laxity Questionnaire
Time Frame: Baseline, 3 Months Post Treatments and 6 Months Post Treatments
The VLQ is a Likert scale with seven responses regarding self-reported vaginal laxity; answer option range from "Very Loose" to "Very Tight". Min: 1; Max: 7 A higher score would indicate "Very Tight" response provided by the subject.
Secondary Outcomes
- Perceived Changes in Vaginal Laxity as Measured by Zimmern Probe at 3 Months Post Treatment(Baseline and 3 Months Post Treatment)
- Incontinence Impact Questionnaire Short Form (IIQ-7)(Baseline, 3 Months Post Treatments and 6 Months Post Treatments)
- Female Sexual Function Index (FSFI)(Baseline, 3 Months Post Treatments and 6 Months Post Treatments)
- Urogenital Distress Short Form (UDI-6)(Baseline, 3 Months Post Treatments and 6 Months Post Treatments)
- Perceived Changes in Vaginal Laxity as Measured by Zimmern Probe at 6 Months Post Treatment(Baseline and 6 Months Post Treatment)
- Gene Expression- Col1A1 as Measured by Fold Change(Baseline and 3 Months Post Treatments)
- Gene Expression- ELN as Measured by Fold Change(Baseline and 3 Months Post Treatments)
- Gene Expression- LOX as Measured by Fold Change(Baseline and 3 Months Post Treatments)
- Gene Expression- Col3A1 as Measured by Fold Change(Baseline and 3 Months Post Treatments)
Investigators
Jeffrey M. Kenkel
Chair
University of Texas Southwestern Medical Center