Radiofrequency and Hybrid Fractional Laser for Vaginal Rejuvenation

Vaginal Atrophy Clinical Trial

Official title:

A Randomized, Placebo-Controlled Trial Evaluating Radiofrequency and Hybrid Fractional Laser for Vaginal Rejuvenation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03316950
• Other study ID #: STU 012017-006
• Status: Completed
• Phase: N/A
• Start date: June 15, 2018
• Est. completion date: April 8, 2021

Study information

• Verified date: December 2022
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 8, 2021
• Est. primary completion date: April 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Vaginal Atrophy

Intervention

Device:
• IntraGen RF
IntraGen is a radiofrequency vaginal rejuvenation device FDA approved for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The hand piece is a disposable monopolar applicator that is used to apply energy internally and externally.
• DiVA
DiVA device utilizes a hybrid fractional laser technology in a wand hand piece. The hand piece is covered by a single use strengthened quartz dilator that allows the hand piece to rotate and provide treatment in a uniform manner.
• Placebo (DIVA/IntraGen combined)
(DIVA/IntraGen combined) IntraGen RF: IntraGen is a radiofrequency vaginal rejuvenation device FDA approved for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The hand piece is a disposable monopolar applicator that is used to apply energy internally and externally. DiVA: DiVA device utilizes a hybrid fractional laser technology in a wand hand piece. The hand piece is covered by a single use strengthened quartz dilator that allows the hand piece to rotate and provide treatment in a uniform manner.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	American Society for Aesthetic Plastic Surgery

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. Erratum In: Lasers Surg Med. 2017 Sep;49(7):727. — View 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. — View 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. — View 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].

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vulvovaginal Symptoms Questionnaire	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.	Baseline, 3 Month Post- treatments and 6 Month Post Treatments
Primary	Vaginal Laxity Questionnaire	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.	Baseline, 3 Months Post Treatments and 6 Months Post Treatments
Secondary	Perceived Changes in Vaginal Laxity as Measured by Zimmern Probe at 3 Months Post Treatment	Perceived changes in vaginal laxity is measured by Zimmern probe which measures vaginal wall elasticity.	Baseline and 3 Months Post Treatment
Secondary	Perceived Changes in Vaginal Laxity as Measured by Zimmern Probe at 6 Months Post Treatment	Perceived changes in vaginal laxity is measured by Zimmern probe which measures vaginal wall elasticity.	Baseline and 6 Months Post Treatment
Secondary	Urogenital Distress Short Form (UDI-6)	UDI-6 measures multiple domains to assess for presence and severity of physical symptoms such as frequency in urination, urine leakage and pain/discomfort.; Min: 0; Max: 100 Higher score would indicate a higher disability	Baseline, 3 Months Post Treatments and 6 Months Post Treatments
Secondary	Incontinence Impact Questionnaire Short Form (IIQ-7)	The Incontinence Impact Questionnaire assesses the impact and extent of incontinence on patients' everyday lives.; Min: 0; Max: 100 Higher scores corresponds to greater degree of disability.	Baseline, 3 Months Post Treatments and 6 Months Post Treatments
Secondary	Female Sexual Function Index (FSFI)	The FSFI is a 19-item validated questionnaire that assesses several domains of sexual function including, desire, arousal, lubrication, orgasm, satisfaction and pain.; Min: 2; Max: 36 Higher scores indicate fewer symptoms and greater sexual satisfaction.	Baseline, 3 Months Post Treatments and 6 Months Post Treatments
Secondary	Gene Expression- Col1A1 as Measured by Fold Change	Biopsies taken of the anterior vaginal wall will be analyzed for gene expression; Fold change= sample/average of the baseline	Baseline and 3 Months Post Treatments
Secondary	Gene Expression- Col3A1 as Measured by Fold Change	Biopsies taken of the anterior vaginal wall will be analyzed for gene expression; Fold change= sample/average of the baseline	Baseline and 3 Months Post Treatments
Secondary	Gene Expression- ELN as Measured by Fold Change	Biopsies taken of the anterior vaginal wall will be analyzed for gene expression; Fold change= sample/average of the baseline	Baseline and 3 Months Post Treatments
Secondary	Gene Expression- LOX as Measured by Fold Change	Biopsies taken of the anterior vaginal wall will be analyzed for gene expression; Fold change= sample/average of the baseline	Baseline and 3 Months Post Treatments