The Efficacy of Intravaginal Laser Therapy in Women With History of Gynecological Cancer Treated With Pelvic Radiotherapy: Double-blind Randomized Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- 10-centimeter Visual Analogue Scale assessing intensity of dyspareunia and dryness
研究概览
简要总结
Women with a history of pelvic radiotherapy due to gynecological cancer, will receive laser therapy for the management of genitourinary syndrome of menopause.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •History of gynecological cancer treated with pelvic radiotherapy
- •last radiotherapy >1 year
- •women sexually active or willing to resume sexual activity
- •symptoms of dyspareunia, vaginal dryness, itching/burning and vaginal bleeding related to sexual intercourse
排除标准
- •Relapse of gynecological cancer
- •prolapse stage >1
- •active genital infection (i.e herpes, vaginitis)
- •underlying pathologies that could interfere with patients compliance to the protocol (i.e any psychiatric condition)
研究组 & 干预措施
Laser
Microablative Fractional CO2 Laser Therapy (The parameters that will be used are the following: 1) Power: 30 ή 40 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter from 1-3 depending on the treatment status, 5) D-pulse mode.)
干预措施: Microablative Fractional CO2 Laser Therapy (Device)
Placebo
Placebo therapy (The parameters that will be used are the following: 1) Power: 0.5 watts, 2) Dwell time:1000μs, 3) Spacing 1000 μm, 4) Depth: SmartStak parameter 1, 5) Smart-pulse mode.
干预措施: Microablative Fractional CO2 Laser Therapy (Device)
结局指标
主要结局
10-centimeter Visual Analogue Scale assessing intensity of dyspareunia and dryness
时间窗: Change from baseline at 1 month post-treatment
It is a straight line with 2 endpoints "0" and "10". Zero defines "no dyspareunia at all" and "no dryness at all" , while 10 "dyspareunia as bad as it could be" and "dryness as bad as it could be". Participants will draw a line at or between the 2 end points. The distance between zero and drawn line will define the intensity of dyspareunia and dryness
次要结局
- Day-to Day Impact of vaginal aging questionnaire (DIVA)(Change from baseline at 1 month post-treatment)
- The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ) cervical cancer module (CX24)(Change from baseline Quality of Life questionnaire (QLQ) cervical cancer module (CX24) at 1-month post-treatment)
- International Consultation on Incontinence Questionnaire Short Form/Female Lower Urinary tract Symptoms (ICIQ-FLUTS)(Change from baseline International Consultation on Incontinence Questionnaire Short Form/Female Lower Urinary tract Symptoms (ICIQ-FLUTS) at 1-month post-treatment)
- Vaginal Health Index Score(Change from baseline Vaginal Health Index Score at 1-month post-treatment)
- 3 days voiding diary(Change from baseline at 1 month post-treatment)
- Patients Global Impression of Improvement(At 1-month post-treatment)
- King's Health Questionnaire (KHQ)(Change from baseline King's Health Questionnaire at 1-month post-treatment)
- Female Sexual Function Index(Change from baseline Female Sexual Function Index at 1-month post-treatment)
- Partner Performance Questionnaire(Change from baseline Partner Performance Questionnaire at 1-month post-treatment)
- Vaginal Maturation Value(Change from baseline Vaginal Maturation Value at 1-month post-treatment)
研究者
Themos Grigoriadis
MD, PhD, Assistant Professor
National and Kapodistrian University of Athens