Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors

Официальное название

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

Обзор

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.

Вмешательства

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  The laser probe is gently inserted up to the top of the vagina, and subsequently withdrawn and rotated in order to deliver a complete treatment of the vaginal wall.

Первичные конечные точки

• Vaginal dryness [Срок оценки: Symptom data is collected at baseline visit and one month after the last treatment]

Вторичные конечные точки (8)

• Change in vaginal pain, itching and soreness [Срок оценки: Symptom data is collected at baseline visit and one month after the last treatment]
• Female Sexual Function Index [Срок оценки: Symptom data is collected at baseline visit and one month after the last treatment]
• Sexual complaint screener - women [Срок оценки: Symptom data is collected at baseline visit and one month after the last treatment]
• Urogenital Distress Inventory [Срок оценки: Symptom data is collected at baseline visit and one month after the last treatment]
• International Consultation on Incontinence Questionnaire Female Urinary Tract Symptoms Sex [Срок оценки: Symptom data is collected at baseline visit and one month after the last treatment]
• Vaginal health index [Срок оценки: Vaginal health index is evaluated at baseline visit and one month after the last treatment]
• Vaginal biopsy [Срок оценки: Vaginal biopsy is collected at baseline visit and one month after the last treatment]
• Vaginal and urinary microbiota [Срок оценки: Vaginal and urine microbiota are collected at baseline visit and one month after the last treatment]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Department of Obstetrics and Gynaecology, Randers Regional Hospital — Randers

Публикации

• 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

Идентификаторы

NCT: NCT06007027 · VagLaser

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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