Elastographic Improvement of Vaginal Atrophy Treated by Er:YAG Laser
Status: Completed
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study is a randomized controlled sham applied study. Its aim is to evaluate the efficacy of Er:YAG laser for the treatment of atrophic vaginitis in postmenopausal women. In this study, demonstration of the efficacy of Er:YAG laser for the treatment of atrophic vaginitis in postmenopausal women is intended with Maturation Index (MI), vaginal pH measurement, Female Sexual Function Index (FSFI), Vaginal Health Index (VaHI), Visual Analogue Scale (VAS) and ultrasonographic elastography
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Postmenopausal women with vaginal atrophy symptoms
• Adult Female, 18 years of age or older
Locations
Other Locations
Turkey
Istanbul University-Cerrahpasa
Istanbul
Istanbul University-Cerrahpaşa
Istanbul
Time Frame
Start Date: 2023-08-21
Completion Date: 2024-02-01
Participants
Target number of participants: 20
Treatments
Experimental: Laser Arm
Non-ablative thermal-only Er:YAG laser (Fotona Dynamis) treatment using R11 and PS03 handpieces
Sham_comparator: Sham Arm
The same procedure is applied but with a sham handpiece.
Related Therapeutic Areas
Sponsors
Leads: Istanbul University - Cerrahpasa