Vaginal CO2 Laser and the Genitourinary Syndrome of Menopause
NCT ID: NCT03754205
Last Updated: 2020-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2018-01-18
2021-01-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Laser Group
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.
Microablative Fractional CO2 laser
3 therapies intravaginally administered will be applied at monthly intervals
Placebo Group
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.
Microablative Fractional CO2 laser
3 therapies intravaginally administered will be applied at monthly intervals
Interventions
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Microablative Fractional CO2 laser
3 therapies intravaginally administered will be applied at monthly intervals
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Menopause
Exclusion Criteria
* 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
FEMALE
Yes
Sponsors
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IRCCS San Raffaele
OTHER
National and Kapodistrian University of Athens
OTHER
Responsible Party
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Themos Grigoriadis
Assistant Professor
Principal Investigators
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Stavros Athanasiou, Associate Proffesor
Role: PRINCIPAL_INVESTIGATOR
National and Kapodistrian University of Athens, Greece
Locations
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Urogynecological Unit of Alexandra Hospital
Athens, , Greece
Countries
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References
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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.
Other Identifiers
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674/03-09-2018
Identifier Type: -
Identifier Source: org_study_id
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