Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors

Launched by UNIVERSITY OF AARHUS · Aug 17, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring the use of vaginal CO2 laser therapy to help breast cancer survivors who are experiencing genitourinary syndrome, which includes symptoms like vaginal discomfort and pain during intercourse. The study will take place over three years and involves different phases. In the first part, 30 participants will receive a series of laser treatments to find the most effective dose. In the second part, 60 women will be divided into two groups—half will receive the active laser treatment, while the other half will receive a placebo (a treatment that looks the same but has no active effect) to see how well the treatment works. Finally, in the third part, the same participants will be followed for a year to assess the long-term effects.

To be eligible for the trial, participants must be breast cancer survivors currently receiving hormonal therapy and must be experiencing symptoms of genitourinary syndrome. They should also be able to read and understand Danish and provide written consent. However, women with certain conditions like pelvic organ prolapse or recent vaginal infections will not be included. Participants can expect to undergo multiple treatments and evaluations, including questionnaires and tests to measure the effects of the therapy. This study is being conducted at Randers Regional Hospital in collaboration with Aarhus University Hospital.

Gender

FEMALE

Eligibility 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