Elastographic Improvement of Vaginal Atrophy Treated by Erbium Yag Laser

NCT06000202 | Completed

• 1 other identifier: 689852
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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)

Outcome Measures

Primary Outcomes (5)

• Efficacy: Rate of improvement in vaginal atrophy

  Evaluation of the efficacy and safety of vaginal atrophy by using ultrasonographic Elastography

  6 months

• Efficacy:Rate of improvement in sexual function

  Evaluation of dyspareunia by Female Sexual Function Index

  6 months

• Efficacy: Rate of improvement in vaginal atrophy

  Evaluation of Maturation Index

  6 months

• Efficacy: Rate of improvement in vaginal atrophy

  Evaluation of Vaginal Health Index

  6 months

• Efficacy: Rate of improvement in pain

  Evaluated by Visual Analogue Scale

  6 months

Secondary Outcomes (1)

• Safety:Incidence and severity of device related Adverse Events

  6 months

Study Arms (2)

Laser Arm

EXPERIMENTAL

Non-ablative thermal-only Er:YAG laser (Fotona Dynamis) treatment using R11 and PS03 handpieces

Device: Fotona Dynamis Er:YAG Laser System

Sham Arm

SHAM COMPARATOR

The same procedure is applied but with a sham handpiece.

Device: Sham

Interventions

Fotona Dynamis Er:YAG Laser System DEVICE

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.

Laser Arm

Sham DEVICE

Er:YAG laser is applied with sham handpiece.

Also known as: Placebo

Sham Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 18 years and older postmenopausal women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women with vaginal atrophy symptoms
• Adult Female, 18 years of age or older

You may not qualify if:

• Patients with a history of previous vaginal operation,
• Patients with pelvic organ prolapse

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (2)

Istanbul University-Cerrahpaşa

Istanbul, 34098, Turkey (Türkiye)

Location

Istanbul University-Cerrahpasa

Istanbul, 34450, Turkey (Türkiye)

Location

Related Publications (1)

• Bayraktar E, Erel CT, Akturk H, Erkan IBO, Hamid R, Alper E, Adaletli I, Urfalioglu M. A novel objective evaluation method, shear wave elastography, in the treatment of atrophic vaginitis by nonablative intravaginal Er:YAG laser, a randomized-sham controlled pilot study. Menopause. 2024 Aug 1;31(8):716-723. doi: 10.1097/GME.0000000000002380. Epub 2024 Jun 11.

  PMID: 38860935 DERIVED

MeSH Terms

Conditions

Dyspareunia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Cemal Tamer Erel, Prof.

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant doesn't know if she receives the sham or laser therapy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Principal investigator

Study Record Dates

• First Submitted: August 12, 2023
• First Posted: August 21, 2023
• Study Start: August 21, 2023
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: It will be available after the completion of the study for a year.

Locations

TU (2)