Laser Therapy Following Radiotherapy for Gynecological Cancer
NCT ID: NCT03714581
Last Updated: 2019-07-30
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
112 participants
INTERVENTIONAL
2018-11-15
2021-06-30
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
Microablative Fractional CO2 Laser Therapy (The 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 Therapy
5 laser therapies intravaginally administered will be applied at monthly intervals.
Placebo
Placebo therapy (The 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 Therapy
5 laser therapies intravaginally administered will be applied at monthly intervals.
Interventions
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Microablative Fractional CO2 Laser Therapy
5 laser therapies intravaginally administered will be applied at monthly intervals.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* last radiotherapy \>1 year
* women sexually active or willing to resume sexual activity
* symptoms of dyspareunia, vaginal dryness, itching/burning and vaginal bleeding related to sexual intercourse
Exclusion Criteria
* prolapse stage \>1
* active genital infection (i.e herpes, vaginitis)
* underlying pathologies that could interfere with patients compliance to the protocol (i.e any psychiatric condition)
FEMALE
Yes
Sponsors
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National and Kapodistrian University of Athens
OTHER
Responsible Party
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Themos Grigoriadis
MD, PhD, Assistant Professor
Principal Investigators
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Stavros Athanasiou, Associate Proffesor
Role: STUDY_DIRECTOR
National and Kapodistrian University of Athens, Greece
Locations
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Urogynecological Unit of Alexandra Hospital
Athens, , Greece
Countries
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Central Contacts
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Facility Contacts
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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.
Athanasiou S, Pitsouni E, Grigoriadis T, Michailidis G, Tsiveleka A, Rodolakis A, Loutradis D. A study protocol of vaginal laser therapy in gynecological cancer survivors. Climacteric. 2020 Feb;23(1):53-58. doi: 10.1080/13697137.2019.1646720. Epub 2019 Sep 2.
Other Identifiers
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143/21-03-2018
Identifier Type: -
Identifier Source: org_study_id
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