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The effect of vaginal erbium laser treatment for the genitourinary syndrome of menopause: A Randomized Controlled Study

The effect of vaginal erbium laser treatment for the genitourinary syndrome of menopause: A Quasi-Randomized Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20171025003
Enrollment
Unknown
Registered
2017-10-25
Start date
2017-04-26
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genitourinary symptoms of menopause quality of life vaginal health index vaginal maturation index vaginal microbiology genitourinary symptoms of menopause GSM vulvovaginal atrophy vaginal maturation index vaginal health index

Interventions

Vaginal Erbium laser( wave length 2940 nm&#44
frequency 1.6 Hz&#44
8 J/cm2) once a month procedure description: transmit the laser therapy within transparent vaginal speculum&#44
starting from inner vaginal canal&#44
then pull off 5 mm each time until reaching hymen.The laser therapy finish after repeat the procedure 3 times.,placebo (Fake vaginal laser procedure)
Experimental Procedure/Surgery,Placebo Comparator Procedure/Surgery
Vaginal Erbium laser,placebo

Sponsors

Faculty of medicine, Ramathibodi hospital, Mahidol university
Lead Sponsor
Faculty of medicine&#44
Collaborator
Ramathibodi hospital&#44
Collaborator
Mahidol university
Collaborator

Eligibility

Sex/Gender
Female
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Postmenopausal women including women with surgical menopause 2. Genitourinary symptoms of menopause affecting quality of life 3. Normal PAP smear 4. Willing to enrol the study

Exclusion criteria

Exclusion criteria: 1. Genital ulcers an and any sexually transmitted disease within 30 days prior enrollment 2.Undiagnosed abnormal uterine bleeding 3. History of any forms of hormone replacement therapy within 3 months 4.photosensitivity 5. Genital prolapse stage 2 or more, according to POP-Q system

Design outcomes

Primary

MeasureTime frame
Genitourinary symptoms 5 months Visual analog scale of each symptoms

Secondary

MeasureTime frame
vaginal maturation index 5 months vaginal cytology and calculate base on intermediate epithelial cells and superficial cells,Vaginal health index 5 months clinical evaluation and scale by investigator,Vaginal microobiology 5 months Nugent scale,adverse events 5 months number and characteristics of adverse events during the study

Countries

Thailand

Contacts

Public ContactArtitaya Singwongsa

Department of Obstetrics and Gynecology, Ramathibodi hospital

artitaya@me.com66890436303

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026