Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-100
SponsorUniversity of Aarhus

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators