An interventional study of SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy in Genitourinary Syndrome of Menopause, sponsored by University of Aarhus. Recruiting at 1 site in Denmark. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
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.
9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 6,515 interventional studies indexed under Syndrome.
Browse Syndrome studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
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.
Device: SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy
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
Device: SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy
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.
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.
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
Plan to share: Undecided
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