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The Aesthetic Surgery Education and Research Foundation

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

The ASERF Scientific Research Committee and Board of Directors are pleased to announce the following grant award:

Researcher: Jeffrey Kenkel, MD

Grant Award: ASERF Interim Grant

Amount Awarded: $159,574

Project Name: A Randomized Placebo-Controlled Trial Evaluating Radiofrequency and Hybrid Fractional Laser for Vaginal Rejuvenation

Project Summary: Recently there has been an explosion of new minimally invasive technologies for the management of postmenopausal vulvovaginal symptoms, vaginal wall laxity, sexual dysfunction, and even mild to moderate urinary incontinence with very limited scientific studies to back the merits of these technologies and their claims.

This is a single-center, randomized, prospective study designed to evaluate the efficacy of radiofrequency and hybrid fractional laser for vaginal rejuvenation.  100 subjects will undergo 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 have completed the study at this time and will be provided treatment, should they choose.  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, and descriptive statistics will be obtained.

We will prospectively study one-hundred consecutive subjects who will be visiting the Plastic Surgery Clinic at the Outpatient Surgery Center for consultation, pre-operative, post-operative, skin care treatment, massage treatments, and miscellaneous visits, or are an employee of the study site (including faculty and residents) or are a UT Southwestern student or trainee (includes medical students or fellows), or are a normal healthy volunteer.  Volunteers will be solicited via word of mouth, flyers, the Center Times, Campus Update emails, and/or the Volunteer Research Participant Registry.

The purpose of the study and specific inclusion and exclusion criteria and potential risks/benefits will be discussed with the potential study subject.  All interested subjects will be given the Consent Form with adequate time for review.  The Investigator and/or his designee will address questions and concerns raised by the subject.  Those subjects who elect to participate will sign the Consent Forms prior to any study procedures.


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