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Recruiting NCT06007027

Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors

No phase Interventional Genitourinary Syndrome of Menopause

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy.
Who it may be relevant to
Registry conditions: Genitourinary Syndrome of Menopause. Basic parameters: 18 years — 100 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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    The laser probe is gently inserted up to the top of the vagina, and subsequently withdrawn and rotated in order to deliver a complete treatment of the vaginal wall.

Primary outcome measures

  • Vaginal dryness [Time frame: Symptom data is collected at baseline visit and one month after the last treatment]
Secondary outcome measures (8)
  • Change in vaginal pain, itching and soreness [Time frame: Symptom data is collected at baseline visit and one month after the last treatment]
  • Female Sexual Function Index [Time frame: Symptom data is collected at baseline visit and one month after the last treatment]
  • Sexual complaint screener - women [Time frame: Symptom data is collected at baseline visit and one month after the last treatment]
  • Urogenital Distress Inventory [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 [Time frame: Symptom data is collected at baseline visit and one month after the last treatment]
  • Vaginal health index [Time frame: Vaginal health index is evaluated at baseline visit and one month after the last treatment]
  • Vaginal biopsy [Time frame: Vaginal biopsy is collected at baseline visit and one month after the last treatment]
  • Vaginal and urinary microbiota [Time frame: Vaginal and urine microbiota are collected at baseline visit and one month after the last treatment]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Department of Obstetrics and Gynaecology, Randers Regional Hospital — Randers

Publications

  • Jacobsen S, Bennetsen MH, Nielsen PS, Glavind-Kristensen M, Jensen AB, Forman A, Waldstrom M, Bor P. Impact of fractional CO2 laser therapy on vaginal wall histology in breast cancer survivors. Lasers Med Sci. 2026 Feb 10;41(1):26. doi: 10.1007/s10103-026-04829-0. PMID 41665827
  • Jacobsen S, Glavind-Kristensen M, Jensen AB, Forman A, Bor P. Vaginal CO2 laser therapy for genitourinary syndrome in breast cancer survivors-VagLaser study protocol: a randomized blinded, placebo-controlled trial. BMC Cancer. 2023 Nov 29;23(1):1164. doi: 10.1186/s12885-023-11656-x. PMID 38031020

Identifiers

NCT: NCT06007027 · VagLaser

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗