Radiofrequency and Hybrid Fractional Laser for Vaginal Rejuvenation
Condition: Vaginal Atrophy
MeSH terms: Atrophy
Study type: Interventional

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.
    

Intervention name(s): IntraGen RF; DiVA; Placebo (DIVA/IntraGen combined)
Intervention type(s): Device; Device; Device
Intervention description(s): 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 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.; (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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: postmenopause; rejuvenation; radiofrequency; diva