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Elastographic Improvement of Vaginal Atrophy Treated by Erbium Yag Laser

NCT06000202 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-04-30

No results posted yet for this study

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

Conditions

  • Vaginal Atrophy
  • Dyspareunia
  • Laser
  • Genitourinary Syndrome of Menopause (GSM)

Interventions

DEVICE

Fotona Dynamis Er:YAG Laser System

The patient receives 2940 nm Er:YAG Laser (XS Dynamis, Fotona, Slovenia) at intervals of 21 days. She receives 3 sessions, in total. Each session consists of application of PS03 handpiece intravaginal with spot size of 7 mm, fluence of 10 j/cm2, frequency of 1.6 Hz and 4-7 pulses per point and 6 passes followed by R11 handpiece intravaginal with spot size of 7 mm, fluence of 10 j/cm2, frequency of 1.6 Hz and 4-7 pulses per point and 3 passes.

DEVICE

Sham

Er:YAG laser is applied with sham handpiece.

Sponsors & Collaborators

  • Istanbul University - Cerrahpasa

    lead OTHER

Principal Investigators

  • Cemal Tamer Erel, Prof. · Istanbul University - Cerrahpasa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-21
Primary Completion
2024-01-01
Completion
2024-02-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06000202 on ClinicalTrials.gov