Vaginal Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors - A Randomized, Blinded, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Vaginal dryness
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Vaginal dryness
时间窗: 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.
次要结局
- Sexual complaint screener - women(Symptom data is collected at baseline visit and one month after the last treatment)
- Urogenital Distress Inventory(Symptom data is collected at baseline visit and one month after the last treatment)
- Change in vaginal pain, itching and soreness(Symptom data is collected at baseline visit and one month after the last treatment)
- Vaginal health index(Vaginal health index is evaluated at baseline visit and one month after the last treatment)
- Vaginal biopsy(Vaginal biopsy is collected at baseline visit and one month after the last treatment)
- International Consultation on Incontinence Questionnaire Female Urinary Tract Symptoms Sex(Symptom data is collected at baseline visit and one month after the last treatment)
- Female Sexual Function Index(Symptom data is collected at baseline visit and one month after the last treatment)
- Vaginal and urinary microbiota(Vaginal and urine microbiota are collected at baseline visit and one month after the last treatment)