Laser Therapy Following Radiotherapy for Gynecological Cancer

National and Kapodistrian University of Athens

Status: Unknown

Conditions: Pelvic Radiotherapy; Dyspareunia; Vaginal Dryness; Gynecological Cancer

Treatments: Device: Microablative Fractional CO2 Laser Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03714581

143/21-03-2018

Details and patient eligibility

About

Women with a history of pelvic radiotherapy due to gynecological cancer, will receive laser therapy for the management of genitourinary syndrome of menopause.

Enrollment: 112 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• History of gynecological cancer treated with pelvic radiotherapy
• 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

• Relapse of gynecological cancer
• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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112 participants in 2 patient groups, including a placebo group

Laser

Experimental group

Description:

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.)

Treatment:

Device: Microablative Fractional CO2 Laser Therapy

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Device: Microablative Fractional CO2 Laser Therapy