Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors

Genitourinary Syndrome of Menopause Clinical Trial

Official title:

Vaginal Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors - A Randomized, Blinded, Placebo-controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06007027
• Other study ID #: VagLaser
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: July 30, 2025

Study information

• Verified date: June 2023
• Source: University of Aarhus
• Contact: Sine Jacobsen, MD
• Email: sinjac[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 30, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Genitourinary Syndrome of Menopause
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Denmark	Department of Obstetrics and Gynaecology, Randers Regional Hospital	Randers

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Symptom data is collected at baseline visit and one month after the last treatment
Secondary	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.	Symptom data is collected at baseline visit and one month after the last treatment
Secondary	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	Symptom data is collected at baseline visit and one month after the last treatment
Secondary	Sexual complaint screener - women	Addressing all domains of sexual dysfunction. Range 0-60, higher score indicate increased symptom severity	Symptom data is collected at baseline visit and one month after the last treatment
Secondary	Urogenital Distress Inventory	For urinary symptoms; irritative symptoms, obstructive/discomfort and stress symptoms. Range 0-18, higher score indicate higher disability	Symptom data is collected at baseline visit and one month after the last treatment
Secondary	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.	Symptom data is collected at baseline visit and one month after the last treatment
Secondary	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	Vaginal health index is evaluated at baseline visit and one month after the last treatment
Secondary	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.	Vaginal biopsy is collected at baseline visit and one month after the last treatment
Secondary	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.	Vaginal and urine microbiota are collected at baseline visit and one month after the last treatment