Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors

• ClinicalTrials.gov Identifier: NCT06007027
• Recruitment Status: Not yet recruiting
• First Posted: August 23, 2023
• Last Update Posted: August 23, 2023
• Sponsor: University of Aarhus
• Information provided by (Responsible Party): University of Aarhus

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Genitourinary Syndrome of Menopause	Device: SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Vaginal Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors - A Randomized, Blinded, Placebo-controlled Study
• Estimated Study Start Date: March 1, 2024
• Estimated Primary Completion Date: January 30, 2025
• Estimated Study Completion Date: July 30, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Vaginal dryness [ Time Frame: Symptom data is collected at baseline visit and one month after the last treatment ]
   Participant are asked to complete the 10-cm visual analog scale (VAS) ranging for 0 to 10, with higher score indicating worse vaginal dryness.

Secondary Outcome Measures :

1. Change in vaginal pain, itching and soreness [ Time Frame: Symptom data is collected at baseline visit and one month after the last treatment ]
   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.
2. Female Sexual Function Index [ Time Frame: Symptom data is collected at baseline visit and one month after the last treatment ]
   Sexual function parameters; desire, arousal, lubrication, orgasm, satisfaction and pain. Range 2-36, the threshold of 26.55 indicates sexual dysfunction
3. Sexual complaint screener - women [ Time Frame: Symptom data is collected at baseline visit and one month after the last treatment ]
   Addressing all domains of sexual dysfunction. Range 0-60, higher score indicate increased symptom severity
4. Urogenital Distress Inventory [ Time Frame: Symptom data is collected at baseline visit and one month after the last treatment ]
   For urinary symptoms; irritative symptoms, obstructive/discomfort and stress symptoms. Range 0-18, higher score indicate higher disability
5. International Consultation on Incontinence Questionnaire Female Urinary Tract Symptoms Sex [ Time Frame: Symptom data is collected at baseline visit and one month after the last treatment ]
   Evaluation of female sexual matters associated with their lower urinary tract symptoms. Range 0-14, higher values indicating increased symptom severity.
6. Vaginal health index [ Time Frame: Vaginal health index is evaluated at baseline visit and one month after the last treatment ]
   subjective scoring of moisture, fluid volume, epithelial integrity and elasticity and objective scoring of pH. Range 5-25, higher scores indicate better health
7. Vaginal biopsy [ Time Frame: Vaginal biopsy is collected at baseline visit and one month after the last treatment ]
   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.
8. Vaginal and urinary microbiota [ Time Frame: Vaginal and urine microbiota are collected at baseline visit and one month after the last treatment ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Sine Jacobsen, MD; sinjac@rm.dk

Contact: Pinar Bor; 78421069

Locations

Denmark

Department of Obstetrics and Gynaecology, Randers Regional Hospital

Randers, Denmark, 8930

Contact: Sine Jacobsen sinjac@rm.dk

Contact +4578421069

Sponsors and Collaborators

University of Aarhus

More Information

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT06007027
• Other Study ID Numbers: VagLaser
• First Posted: August 23, 2023
• Last Update Posted: August 23, 2023
• Last Verified: June 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Aarhus:

laser; mamma cancer

Additional relevant MeSH terms:

Syndrome; Disease; Pathologic Processes