vaginal atrophy Fractional carbon dioxide laser Vaginal atrophy Postmenopausal women
Conditions
Interventions
Patients will receive vaginal microablative fractional CO2 laser treatment for 3 sessions every 4 weeks interval using laser system(SmartXide2 V2LR,
Italy).
The vaginal laser probe will be inserted into the total length of vagina and subsequently withdrawn for every 0.5 centimeters following each laser beam application until the distal end of vagi
Experimental Device,Sham Comparator Device
vaginal microablative fractional carbon dioxide laser,sham procedure
Sponsors
THE 90TH ANNIVERSARY OF CHULALONGKORN UNIVERSITY FUND ( Ratchadaphiseksomphot Endowment Fund)
Eligibility
Sex/Gender
Female
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Postmenopausal women attending Gynecology outpatient clinic, King Chulalongkorn Memorial Hospital 2. Having symptoms and signs of vaginal atrophy with moderate to severe intensity 3. Age 50 years 4. Absence of menstruation for at least 12 months
Exclusion criteria
Exclusion criteria: 1. Using of any hormonal treatment within 6 months 2. Using vaginal moisturizers, lubricants or any local preparation within 30 days 3. Having narrow introitus less than 2 cms(vaginal probe size) 4. Women who have never had sexual intercourse 5. Having acute or recurrent urinary tract infection 6. Having active genital infection(e.g. herpes genitalis, vaginal candidiasis) 7. Having pelvic organ prolapse stage 2 according to POP-Q classification(25) 8. Having previous pelvic reconstruction surgery 9. Having any serious medical condition that could interfere with study compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vaginal Health Index Score every 4 weeks determine 5 signs of vaginal atrophy by inspection and pH testing | — |
Secondary
| Measure | Time frame |
|---|---|
| Vaginal Atrophy Symptom(VAS) score every 4 weeks interview for assessment of intensity of vaginal atrophy symptoms ,vaginal symptom related to vaginal atrophy every 4 weeks complete the ICIQ-VS questionnaire,quality of life related to vaginal atrophy every 4 weeks complete of SF-12 questionnaire | — |
Countries
Thailand
Contacts
Public ContactPurim Ruanphoo
Chulalongkorn University
Outcome results
None listed