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Trial record 1 of 4 for:    25410301 [PUBMED-IDS]
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Radiofrequency and Hybrid Fractional Laser for Vaginal Rejuvenation

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ClinicalTrials.gov Identifier: NCT03316950
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : December 17, 2018
Sponsor:
Collaborator:
American Society for Aesthetic Plastic Surgery
Information provided by (Responsible Party):
Jeffrey M. Kenkel, University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Vaginal Atrophy Device: IntraGen RF Device: DiVA Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled Trial Evaluating Radiofrequency and Hybrid Fractional Laser for Vaginal Rejuvenation
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : May 30, 2020

Arm Intervention/treatment
Experimental: 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.
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.

Sham Comparator: IntraGen Sham
Patients will undergo all acts of receiving radiofrequency treatment, but no direct energy will be applied. Patients will have 3 sham treatments space one month apart. Each treatment session will be a total of 20 minutes. Prior to sham 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.
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.

Experimental: 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.
Device: 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.

Sham Comparator: DiVA Sham
Patients randomized into the DiVA sham group will undergo all acts of receiving DiVA treatment, but not direct energy will be applied. Patients will have a total of 3 treatments, spaced 1 month apart. Each treatment will last approximately 10 minutes. Prior to sham 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.
Device: 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.

Experimental: 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.
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.

Device: 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.




Primary Outcome Measures :
  1. Vulvovaginal Symptoms Questionnaire [ Time Frame: 12 months - 18 months ]
    questionnaire assessing vulvovaginal symptoms in postmenopausal women including discomfort, emotions, life-impact, and sexual impact

  2. Vaginal Laxity Questionnaire [ Time Frame: 12 months - 18 months ]
    validated questionnaire assessing laxity


Secondary Outcome Measures :
  1. Zimmern Probe [ Time Frame: 12 months - 18 month ]
    measures vaginal wall elasticity

  2. Urogenital Distress Short Form (UDI-6) [ Time Frame: 12 months - 18 months ]
    questionnaire assessing urinary incontinence

  3. Incontinence Impact Questionnaire Short Form (IIQ-7) [ Time Frame: 12 months - 18 months ]
    questionnaire assessing urinary incontinence

  4. Female Sexual Function Index (FSFI) [ Time Frame: 12 months - 18 months ]
    questionnaire assessing sexual dysfunction

  5. Histological changes [ Time Frame: 12 months - 18 months ]
    Biopsies taken of the anterior vaginal wall will be analyzed for histology and gene expression



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03316950


Contacts
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Contact: Jennifer Barillas 214-645-8907 jennifer.barillas@utsouthwestern.edu
Contact: Debby Noble 214-648-8686 debby.noble@utsouthwestern.edu

Locations
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United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Debby Noble       debby.noble@utsouthwestern.edu   
Principal Investigator: Jeffrey Kenkel, MD         
Sub-Investigator: John Hoopman         
Sub-Investigator: Yucel Akgul, MD, PhD         
Sub-Investigator: Deniz Basci, MD         
Sub-Investigator: Kimberly Kho, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
American Society for Aesthetic Plastic Surgery
Investigators
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Principal Investigator: Jeffrey Kenkel, MD Chair & Professor

Publications:
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].

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Responsible Party: Jeffrey M. Kenkel, Chair, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03316950     History of Changes
Other Study ID Numbers: STU 012017-006
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Jeffrey M. Kenkel, University of Texas Southwestern Medical Center:
postmenopause
rejuvenation
radiofrequency
diva

Additional relevant MeSH terms:
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Atrophy
Pathological Conditions, Anatomical