Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors

University of Aarhus

Status: Enrolling

Conditions: Genitourinary Syndrome of Menopause

Treatments: Device: SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy

Study type: Interventional

Funder types: Other

Identifiers

NCT06007027

VagLaser

Details and patient eligibility

About

This project will be based on three studies over a period on three years. The first study is a dose response study that includes 30 breast cancer survivors. They will receive a total of 5 laser treatments with 4-6 weeks intervals The second study is a double-blind randomized controlled trial, that includes 60 breast cancer survivors. 30 of those will receive active intervention and 30 will receive placebo laser treatment and act as controls. Based on the results of the dose response study, a treatment consists of three to five laser treatments every 3 weeks. The third and last study is a one-year follow-up on study two. The conditions are evaluated before and after each treatment by questionnaires, vaginal fluid pH values, punch biopsies and vaginal and urine microbiome. The studies is conducted at the Department of Obstetrics and Gynaecology at Randers Regional Hospital in collaboration with Department of Obstetrics and Gynaecology and Department of Oncology at Aarhus University Hospital.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Breast cancer survivor in endocrine therapy
• Symptomatic genitourinary symdrom of menopause with vaginal discomfort and/or dyspareunia
• Able to read and understand Danish
• Able to give written informed consent

Exclusion criteria

• Pelvic organ prolapse ≥ stage 2 according to the Pelvic Organ Prolapse Quantification staging system
• Use of non-hormonal/hormonal vaginal therapies (1 and 12 months prior to the baseline visit, respectively)
• Use of Chemotherapy (6 months prior to the baseline visit)
• Acute urinary tract infection or active genital infection
• History of vaginal reconstructive surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Active laser group

Experimental group

Description:

In the active laser group, participants are treated intravaginally with the fractional microablative CO2 laser system (SmartXIDE2V2LR, MonaLisa Touch, DEKA, Florence, Italy), using the following setting; dot power 30 watt, dwell time 1000 μs, dot spacing 1000 μs and the smart stack parameter from 2 to 3. At the level of the vaginal introitus, the dot power decreases to 20 Watt.

Treatment:

Device: SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy

Sham laser group

Sham Comparator group

Description:

In the sham laser group, participants are treated intravaginally with the fractional microablative CO2 laser system (SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy), using the following setting; dot power 0,5 watt, dwell time 100 μs, dot spacing 2000 μs and the smart stack parameter from 1 to 1

Treatment:

Device: SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy