Laser Procedures for Vaginal Atrophy - Dallas
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.
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.
This study is open at one site:
UT Southwestern Medical Center
Study Principal Investigator
Jeffrey Kenkel, MD Chair & Professor
Contact by email