Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors

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

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 Overview

• Status: Not yet recruiting
• Conditions: Genitourinary Syndrome of Menopause
• Intervention / Treatment: Device: SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sine Jacobsen, MD; Email: sinjac@rm.dk
• Study Contact Backup: Name: Pinar Bor; Phone Number: 78421069

Study Locations

• Denmark
  • Randers, Denmark, 8930
    • Department of Obstetrics and Gynaecology, Randers Regional Hospital
    • Contact: Sine Jacobsen; Email: sinjac@rm.dk
    • Contact: Phone Number: +4578421069

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active laser group; 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; 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.
Sham Comparator: Sham laser group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Aarhus

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): January 30, 2025
• Study Completion (Estimated): July 30, 2025

Study Registration Dates

• First Submitted: August 1, 2023
• First Submitted That Met QC Criteria: August 17, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: laser; mamma cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: VagLaser

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No