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Research & Clinical Trials > Study Search Tool > Radiofrequency and Hybrid Fractional Laser for Vaginal Rejuvenation

Radiofrequency and Hybrid Fractional Laser for Vaginal Rejuvenation

This study is open to:

The study is open to women who:

  • are between 40 and 65 years of age
  • are post-menopausal with one or more of the following:
    • vulvar itching
    • vulvar burning or stinging
    • vulvar pain
    • vulvar irritation
    • vulvar dryness
    • vulva or vaginal discharge or odor
  • must be willing to complete one year of appointments in Dallas
This study is not open to:

Women who have any of the following are not eligible:

  • history of other laser vaginal therapy within one year
  • vaginal hormone replacement therapy (systemic replacement is not excluded)
  • prior labiaplasty surgery
  • prior abdominoplasty surgery
  • 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
  • on steroids 
  • diffuse pain syndrome or chronic pain requiring daily narcotics
  • chronic vaginitis including bacterial vaginosis, HPV, herpes, or other active STI
  • recent abnormal Pap smear test result
  • recent abnormal pelvic exam (i.e. concerning lesions)
  • abnormal genital bleeding
Radiofrequency and Hybrid Fractional Laser for Vaginal Rejuvenation

Laser Procedures for Vaginal Atrophy - Dallas

Clinicaltrials.gov identifier:
NCT03316950

Quality of Life:
Breast Cancer Survivor
High Risk But No Cancer

Study Contact Information

Debby Noble: Contact by phone 214-648-8686 or by email       

About the Study

This is a clinical trial designed to test the effectiveness of laser procedure for treating vaginal symptoms associated with menopause.

Study Background

Women can have vaginal and pelvic changes after menopause that can cause vaginal and sexual symptoms. Genitourinary Syndrome of Menopause (GSM) is a condition of postmenopausal women due to estrogen deprivation. GSM can lead to these symptoms: 

  • vulvar itching
  • pain during intercourse
  • vaginal dryness
  • urinary urgency and frequency
  • frequent bladder infections
  • vaginal bleeding
  • pelvic pain or pressure

"Vaginal rejuvenation" is a catch-all term of procedures that may provide relief from postmenopausal vaginal symptoms. Several companies have emerged with non-invasive or minimally-invasive technologies to alleviate these conditions through laser treatments. 

Type of Study

This is a placebo-controlled, four-arm, randomized, blinded study with crossover. The study is designed to evaluate the efficacy of laser treatment for vaginal rejuvenation. 

  • The study is  placebo-controlled. Placebos are harmless, but inactive treatments. Placebos are only used in research in situations where there is no standard treatment. Participants in the placebo group will receive "sham" treatment using an inactive laser. All other care in the placebo group will be similar to the active group.
  • The study has four arms. This means that participants in the study will be placed into one of four groups and receive one of four treatments 
    • IntraGen RF treatment 
    • IntraGen RF unit placebo 
    • DiVa HFL unit 
    • DiVa HFL unit placebo 
  • This is a randomized study, which means that participants will be placed into one of the two treatment groups by chance. Neither patients nor the research doctor will choose the group participants are placed in. 
  • The study is blinded. This means that the participants will not know whether they are receiving the active or the inactive laser treatments. The study doctor will know which treatment the patient is receiving. 
  • This is a crossover study. Participants who received placebo will be allowed to cross-over to the treatment group at the end of the study, should they choose to. 

What the Study Entails

  • 100 subjects will be randomized to one of the four groups listed above. 
  • Participants will undergo a three-part treatment of the vulvovaginal area using an active unit or a placebo based on the arm they are assigned to.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 for vaginal symptoms.
  • Participants 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. 

Study Site

This study is open at one site:

UT Southwestern Medical Center
Dallas, TX

Study Principal Investigator

Jeffrey Kenkel, MD Chair & Professor
Contact by email
 

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