Vaginal Atrophy Treatment Using Microablative Fractional Carbon Dioxide Laser: A Randomized Patient and Evaluator-Blinded Sham-Controlled Trial
- Conditions
- vaginal atrophyPostmenopausal womenFractional carbon dioxide laserVaginal atrophy
- Registration Number
- TCTR20160627002
- Lead Sponsor
- THE 90TH ANNIVERSARY OF CHULALONGKORN UNIVERSITY FUND ( Ratchadaphiseksomphot Endowment Fund)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 88
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Vaginal Health Index Score every 4 weeks determine 5 signs of vaginal atrophy by inspection and pH testing
- Secondary Outcome Measures
Name Time Method 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