Genitourinary syndrome of menopause Vaginal atrophy Vaginal radiofrequency Monopolar radiofrequency Genitourinary syndrome of menopause Vaginal atrophy
Conditions
Interventions
Vaginal monopolar RF at 448 kHz (INDIBA, Spain) for 20 minutes each session weekly for six consecutive weeks. This machine was approved by both the US FDA and the Thai FDA,The procedure will be perfor
Experimental Radiation,Sham Comparator No treatment
Vaginal RF ,Sham
Sponsors
Ratchadapisek Sompot Research Fund type 1
Eligibility
Sex/Gender
Female
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Thai postmenopausal women age at least 45 years or older who experienced amenorrhea for 12 months or more 2. Diagnosed with genitourinary syndrome of menopause (GSM). 3. Unable or unwilling to use other treatment options for GSM and express a preference for participating in the study. 4. Capable of completing the treatment and follow-up visits throughout the study period.
Exclusion criteria
Exclusion criteria: 1.History of hormonal therapy within the past 6 months or current use medications such as estrogen compound, Tamoxifen, Aromatase inhibitors 2. History of vaginal moisturizer, lubricant applications or other treatments for GSM within the past 30 days or currently 3. Presence of Acute/recurrent urinary tract infection or active genital infection, such as Abscess or Herpes zoster 4. Contagious genital infection including Condyloma, HIV infection 5. Use Intrauterine Device (IUD) 6. Presence of pacemakers or other electronic implants. 7. Abnormal cervical cytology, vulvar lesions, vaginal lesions 8. History of deep venous thrombosis or emboli (VTE) 9. Recent pelvic surgery within 12 months 10.History of genital surgery with mesh includes transvaginal mesh or mid-urethral sling 11.Prior pelvic irradiation 12.Unexplained Abnormal vaginal bleeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GSM symptoms at 4 weeks posttreatment Vaginal Health Index (VHI) score | — |
Secondary
| Measure | Time frame |
|---|---|
| QOL at 4 weeks posttreatment International Consultation on Incontinence Modular Questionnaire-Vaginal Symptoms (ICIQ-VS) questionnaire,GSM symptoms at 4 weeks posttreatment Vaginal Atrophy Score (VAS),Satisfaction Every session and at 4 weeks posttreatment Visual analog scale,Adverse events Every session and at 4 weeks posttreatment open ended questions | — |
Countries
Thailand
Contacts
Public ContactApisit Rungruengsirichok
King Chulalongkorn Memorial Hospital
Outcome results
None listed