Clinical trial NCT03316950: Radiofrequency and Hybrid Fractional Laser for Vaginal Rejuvenation
Official title: A Randomized, Placebo-Controlled Trial Evaluating Radiofrequency and Hybrid Fractional Laser for Vaginal Rejuvenation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Atrophy
Keywords: postmenopause
rejuvenation
radiofrequency
diva
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: American Society for Aesthetic Plastic Surgery
First posted: 2017-10-23
Enrollment: 52
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Vulvovaginal Symptoms Questionnaire
timeFrame: Baseline, 3 Month Post- treatments and 6 Month Post Treatments
measure: Vaginal Laxity Questionnaire
timeFrame: Baseline, 3 Months Post Treatments and 6 Months Post Treatments
Secondary outcomes:
measure: Perceived Changes in Vaginal Laxity as Measured by Zimmern Probe at 3 Months Post Treatment
timeFrame: Baseline and 3 Months Post Treatment
measure: Perceived Changes in Vaginal Laxity as Measured by Zimmern Probe at 6 Months Post Treatment
timeFrame: Baseline and 6 Months Post Treatment
measure: Urogenital Distress Short Form (UDI-6)
timeFrame: Baseline, 3 Months Post Treatments and 6 Months Post Treatments
measure: Incontinence Impact Questionnaire Short Form (IIQ-7)
timeFrame: Baseline, 3 Months Post Treatments and 6 Months Post Treatments
measure: Female Sexual Function Index (FSFI)
timeFrame: Baseline, 3 Months Post Treatments and 6 Months Post Treatments
measure: Gene Expression- Col1A1 as Measured by Fold Change
timeFrame: Baseline and 3 Months Post Treatments
measure: Gene Expression- Col3A1 as Measured by Fold Change
timeFrame: Baseline and 3 Months Post Treatments
measure: Gene Expression- ELN as Measured by Fold Change
timeFrame: Baseline and 3 Months Post Treatments
measure: Gene Expression- LOX as Measured by Fold Change
timeFrame: Baseline and 3 Months Post Treatments
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: Chair & Professor
name: Jeffrey Kenkel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alinsod RM. Transcutaneous temperature controlled radiofrequency for orgasmic dysfunction. Lasers Surg Med. 2016 Sep;48(7):641-5. doi: 10.1002/lsm.22537. Epub 2016 May 19.
citation: Millheiser LS, Pauls RN, Herbst SJ, Chen BH. Radiofrequency treatment of vaginal laxity after vaginal delivery: nonsurgical vaginal tightening. J Sex Med. 2010 Sep;7(9):3088-95. doi: 10.1111/j.1743-6109.2010.01910.x.
citation: Sekiguchi Y, Utsugisawa Y, Azekosi Y, Kinjo M, Song M, Kubota Y, Kingsberg SA, Krychman ML. Laxity of the vaginal introitus after childbirth: nonsurgical outpatient procedure for vaginal tissue restoration and improved sexual satisfaction using low-energy radiofrequency thermal therapy. J Womens Health (Larchmt). 2013 Sep;22(9):775-81. doi: 10.1089/jwh.2012.4123. Epub 2013 Aug 16.
citation: Zerbinati N, Serati M, Origoni M, Candiani M, Iannitti T, Salvatore S, Marotta F, Calligaro A. Microscopic and ultrastructural modifications of postmenopausal atrophic vaginal mucosa after fractional carbon dioxide laser treatment. Lasers Med Sci. 2015 Jan;30(1):429-36. doi: 10.1007/s10103-014-1677-2. Epub 2014 Nov 20.
citation: Paul M, Blugerman G, Kreindel M, Mulholland RS. Three-dimensional radiofrequency tissue tightening: a proposed mechanism and applications for body contouring. Aesthetic Plast Surg. 2011 Feb;35(1):87-95. doi: 10.1007/s00266-010-9564-0. Epub 2010 Sep 11.
citation: Peet J. Evaluation of the Safety and Efficacy of Hybrid Fractional 2940 nm and 1470 nm Lasers for Treatment of Vaginal Tissue: Pilot Study. [White paper].