Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Genitourinary Syndrome of Menopause | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Active laser group
- description
- 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.
- interventionNames
- Device: SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy
- type
- SHAM_COMPARATOR
- label
- Sham laser group
- description
- 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
- interventionNames
- Device: SmartXIDE2V2LR, Monalisa Touch, DEKA, Florence, Italy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDJacobsen 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
- DERIVEDJacobsen 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