NCT05713435招募中不适用
Use of Fractional CO2 Laser Versus Erbium:YAG Laser for the Treatment of Genitourinary Syndrome of Menopause (GSM) in Patients Using Aromatase Inhibitors: Double Blinded Randomized Controlled Clinical Trial.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- change in severity dryness as most bothersome symptom (MBS) of GSM at 3 months after the end of treatment
研究概览
简要总结
To study the efficacy and safety of intravaginal CO2 laser versus intravaginal Er:YAG laser and sham application in alleviating genitourinary symptoms in patients receiving an aromatase inhibitor as adjuvant treatment of breast cancer
详细描述
The objective is to compare microablative fractional CO2 laser (CO2 laser) (SmartXide2 V2 LR, Monalisa Touch; DEKA, Florence, Italy) and non-ablative photothermal Erbium:YAG laser (Er:YAG laser) (Fotona Smooth™ XS; Fotona, Ljubljana, Slovenia) - with sham vaginal applications for treatment of vaginal dryness as the leading symptom in breast cancer patients with iatrogenic menopause and treated with an AI.
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
- Double (Participant, Outcomes Assessor)
盲法说明
participant and outcome assessor are blinded
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
- •Recruited participants will meet all of these criteria:
- •a history of breast cancer
- •premenopausal at diagnosis of breast cancer
- •using AI as an adjuvant treatment
- •moderate to severe symptoms of GSM (VAS ≥ 4/10)
- •currently menopausal, which can be either biochemical menopause as confirmed after chemotherapy, surgical or medicinally induced (GnRH analogues for the duration of the trial)
排除标准
- •Not willing to abstain from vaginal intercourse for 1 week following laser therapy
- •Use of non-hormonal vaginal preparations within the last 6 weeks before inclusion
- •Use of hormonal therapy within 6 months prior to inclusion (systemic or local)
- •Acute urinary or genital tract infections
- •A history of genital fistula, a thin rectovaginal septum as determined by the investigator, or history of fourth degree laceration
- •Prolapse ≥ grade 2 according to the Pelvic Organ Prolapse Quantification System
- •Previous vaginal mesh implantation
- •Abnormal result in the last cervical smear (maximum 36 month before enrollment)
- •Active cancer treatment (radiotherapy or chemotherapy) ongoing or planned prior to the measurement of the primary outcome (6 months after inclusion, 3 months after last laser)
- •Vaginal stenosis that does not allow the placement of the laser probe
- •Any condition that could interfere with study compliance
结局指标
主要结局
change in severity dryness as most bothersome symptom (MBS) of GSM at 3 months after the end of treatment
时间窗: at 3 months after the end of treatment
scored on a 10 cm VAS
次要结局
- Patient reported effect of laser on other GSM symptoms(at 3 months after the end of treatment)
- Female Sexual Function Index (FSFI)(at 3 months after the end of treatment)
- Vaginal Maturation Value (VMV)(at 3 months after the end of treatment)
- Urinary Distress Index (UDI-6)(at 3 months after the end of treatment)
- Vaginal pH(at 3 months after the end of treatment)
- Description of adverse events(until 1 month after the last treatment visit)
- Vaginal Health Index Score (VHIS)(at 3 months after the end of treatment)
- The degree of discomfort of the treatment procedure by the participant(at the end of the each treatment-visit)
- The longevity of the effect(at 24 months after the end of treatment)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Fractional CO2 Vaginal LASER Therapy for Recurrent Urinary Tract InfectionUrinary Tract InfectionsNCT04301934Mayo Clinic12
Enrolling By Invitation
4 期
Efficacy of fractional CO2 vaginal laser treatment of overactive bladder in Postmenopausal women : a double- blinded randomized controlled studypostmenopausal women with overactive bladder symptompostmenopausal women , overactive bladder , fractional CO2 vaginal laserTCTR20211022005Routine to research unit Siriraj Hospital50
尚未招募
不适用
Fractional co2 Laser Followed by Either Vitamin c or Tranexamic Acid in Treatment of Melasma.MelasmaNCT05911698Khadija Qenawi25
Unknown
不适用
Fractional CO2 Laser Therapy Versus 4% Topical Lidocaine Gel for Dyspareunia in Breast Cancer SurvivorsDyspareuniaNCT03257670University of Cincinnati70
已完成
不适用
Fractional / Pixel CO2 Laser Treatment of Vulvar Atrophy and Lichen SclerosusVaginal AtrophyLichen SclerosusNCT03063684Hadassah Medical Organization16