Erbium:Yag Laser vs Hyaluronic Acid Suppository for GSM in Breast Cancer (BC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- genitorurinary symptoms of menopause (GSM) determined by vaginal health index score
研究概览
简要总结
All women from the outpatient department with a history of BC and GSM (genitourinary symptoms of menopause) symptoms will be invited to participate.
After informed consent patients are either randomized to intravaginal laser or hyaluronic acid suppository treatment intravaginally, respectively. Laser treatment will be performed twice, at baseline and after 1 month. The intravaginal hyaluronic acid suppository therapy will be applied daily during the first 10 days and then every third day until the three months follow-up.
At baseline and three months follow-up the following questionnaires will be filled out (VAS, (PGI-I, PGI-S, Female Sexual health questionnaire (EORTC), Baessler questionnaire, EORTC quality of life questionnaire, ZUF-8).
详细描述
Device I- Laser The laser device is the Juliet feminine laser to treat women with SUI (Stress Urinary Incontinence), GSM and vaginal laxity. Asclepion' s headquarters are located in "Asclepion Laser Technologies GmbH - Brüsseler Str. 10 - 07747 Jena - Germany".
Device II- Suppository The second device is a vaginal suppository called "Cikatridina" manufactured by the company Angelini to treat women with GSM. Angelini Pharma Österreich GmbH's headquarters are located in Brigittenauer Lände 50-54, 1200 Wien, Austria.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •genital symptoms of dryness/ burning/ irritation
- •and/ or lack of lubrication during sexual intercourse/ sexual discomfort or pain
- •and/or symptoms of urgency and dysuria or recurrent urinary tract infection
- •Age 18-80
- •History of BC and/ or DCIS
- •Completed locoregional therapy
- •Current antihormonal therapy for BC possible
- •Intravaginal treatment with creams/ suppositories other than study medicationshould be ceased during the trial
排除标准
- •Current or past genitourinary malignancy
- •Abnormal PAP smear
- •Current genitourinary tract infection
- •Abnormal uterine bleeding
- •photosensitive medication
结局指标
主要结局
genitorurinary symptoms of menopause (GSM) determined by vaginal health index score
时间窗: 3 months
Vaginal Health Score Index (VHIS) evaluates the appearance of the vaginal mucosa (elasticity, pH, vaginal discharge, mucosal integrity and moisture) on a scale from 1 to 5 each. The lower the score the worse the symptom.
次要结局
- Symptoms severity- visual analogue scale(3 months)
- Patient satisfaction with treatment/ inpatient management(3 months)
- Discontinuation rate(3 months)
- Treatment discomfort / pain; assessed by visual analogue scale(3 months)
- Patient Global Impression of Improvement(3 months)
- Patient Global Impression of Severity(3 months)
- pelvic floor symptoms(3 months)
- Dyspareunia rate(3 months)
- Female Sexual health(3 months)
- Quality of life: EORTC quality of life questionnaire(3 months)