NCT03754205

Brief Summary

This study evaluates the clinical, histopathological, cytological and microbiological efficacy of Microablative Fractional CO2 laser intravaginally administered in postmenopausal women with Genitourinary Syndrome of Menopause. Half participants will receive active CO2 laser therapy, while the other half will receive placebo CO2 laser therapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

2.2 years

First QC Date

October 28, 2018

Last Update Submit

January 13, 2020

Conditions

Vaginal Atrophy

Outcome Measures

Primary Outcomes (1)

  • 10-centimeter Visual Analogue Scale assessing intensity of dyspareunia and dryness

    It is a straight line with 2 endpoints "0" and "10". Zero defines "no dyspareunia at all" and "no dryness at all" , while 10 "dyspareunia as bad as it could be" and "dryness as bad as it could be". Participants will draw a line at or between the 2 end points. The distance between zero and drawn line will define the intensity of dyspareunia and dryness

    24-months

Secondary Outcomes (15)

  • Day-to Day Impact of vaginal aging questionnaire (DIVA)

    24 months

  • Patients Global Impression of Improvement

    24 months

  • 10-centimeter Visual Analogue Scale assessing intensity of itching, burning and dysuria

    24 months

  • 3 days voiding diary

    24 months

  • Female Sexual Function Index

    24 months

  • +10 more secondary outcomes

Study Arms (2)

Laser Group

EXPERIMENTAL

Microablative Fractional CO2 laser therapy at monthly intervals. The laser parameters that will be used are the following: (1) Power: 30 ή 40 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter from 1-3 depending on the treatment status, 5) D-pulse mode.

Device: Microablative Fractional CO2 laser

Placebo Group

PLACEBO COMPARATOR

Placebo CO2 laser therapies at monthly intervals. The laser parameters that will be used are the following: 1) Power: 0.5 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter 1, 5) Smart-pulse mode.

Device: Microablative Fractional CO2 laser

Interventions

Microablative Fractional CO2 laserDEVICE

3 therapies intravaginally administered will be applied at monthly intervals

Also known as: SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy
Laser GroupPlacebo Group

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Symptoms of vaginal atrophy (dyspareunia and/or vaginal dryness)
  • Menopause

You may not qualify if:

  • Systemic or local hormonal therapy the last 6 months
  • Use of moisturizers or lubricants the last month
  • Active genital infection (i.e herpes, vaginitis)
  • Prolapse stage \>=2
  • Underlying pathologies that could interfere with the protocol compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urogynecological Unit of Alexandra Hospital

Athens, 11528, Greece

Location

Related Publications (1)

  • Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.

    PMID: 40709601DERIVED

Study Officials

  • Stavros Athanasiou, Associate Proffesor

    National and Kapodistrian University of Athens, Greece

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 28, 2018

First Posted

November 27, 2018

Study Start

January 18, 2018

Primary Completion

April 15, 2020

Study Completion

January 15, 2021

Last Updated

January 14, 2020

Record last verified: 2020-01

Locations

GR(1)