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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
The laser probe is gently inserted up to the top of the vagina, and subsequently withdrawn and rotated in order to deliver a complete treatment of the vaginal wall.
Department of Obstetrics and Gynaecology, Randers Regional Hospital
Randers, Denmark
RECRUITINGVaginal 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.
Time frame: Symptom data is collected at baseline visit and one month after the last treatment
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.
Time frame: Symptom data is collected at baseline visit and one month after the last treatment
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
Time frame: Symptom data is collected at baseline visit and one month after the last treatment
Sexual complaint screener - women
Addressing all domains of sexual dysfunction. Range 0-60, higher score indicate increased symptom severity
Time frame: Symptom data is collected at baseline visit and one month after the last treatment
Urogenital Distress Inventory
For urinary symptoms; irritative symptoms, obstructive/discomfort and stress symptoms. Range 0-18, higher score indicate higher disability
Time frame: Symptom data is collected at baseline visit and one month after the last treatment
International Consultation on Incontinence Questionnaire Female Urinary Tract Symptoms Sex
Evaluation of female sexual matters associated with their lower urinary tract symptoms. Range 0-14, higher values indicating increased symptom severity.
Time frame: Symptom data is collected at baseline visit and one month after the last treatment
Vaginal health index
subjective scoring of moisture, fluid volume, epithelial integrity and elasticity and objective scoring of pH. Range 5-25, higher scores indicate better health
Time frame: Vaginal health index is evaluated at baseline visit and one month after the last treatment
Vaginal biopsy
The biopsy of 4\*4 mm is taken from the lateralt vaginal wall, 2-3 cm from inotroitus. Afterwards fixated i formalin and the processed for light microsopy by a specialized gynaecological pathologist reporting on the changes in the histology of vaginal epithel and lamina propria.
Time frame: Vaginal biopsy is collected at baseline visit and one month after the last treatment
Vaginal and urinary microbiota
One polyester swap (FLOQSwab) is used to sample mid-vagina for microbial analysis and immediately been placed at - 80 °C until further processing. Urine is collected in a 50 mL collection tube using the clean catch method for women. Afterwards aliquoted into 10 mL fractions and immediately been placed at - 80 °C until further processing. DNA is isolated from samples using standard DNA isolation kits and microbiota composition determined using 16S rRNA gene sequencing. Microbiota composition is compared between groups and over time based on alpha- and beta-diversity measures, as well as changes in relative abundances of individual bacteria.
Time frame: Vaginal and urine microbiota are collected at baseline visit and one month after the last treatment
Pinar Bor
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.