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.
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
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
Parallel
SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy
DeviceThe laser probe is gently inserted up to the top of the vagina, and subsequently withdrawn and rotated in order to deliver a complete treatment of the vaginal wall.
Vaginal dryness
Participant are asked to complete the 10-cm visual analog scale (VAS) ranging for 0 to 10, with higher score indicating worse vaginal dryness.
Change in vaginal pain, itching and soreness
Evaluated with visual analog scale for vaginal pain, itching, soreness. 10-cm visual analog scale (VAS) ranging for 0 to 10, with higher score indicating worse symptoms.
Female Sexual Function Index
Sexual function parameters; desire, arousal, lubrication, orgasm, satisfaction and pain. Range 2-36, the threshold of 26.55 indicates sexual dysfunction
Sexual complaint screener - women
Addressing all domains of sexual dysfunction. Range 0-60, higher score indicate increased symptom severity
Urogenital Distress Inventory
For urinary symptoms; irritative symptoms, obstructive/discomfort and stress symptoms. Range 0-18, higher score indicate higher disability
Click on the lead sponsor to view all of their trials.
