NCT04021966已完成不适用
Use of Fractional CO2 Laser for the Treatment of Vulvovaginal Atrophy: a Double-blinded Randomized Placebo-controlled Clinical Trial.
prof. dr. Jan Deprest2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Primary outcome measure is the change in severity of most bothersome symptom (MBS)
研究概览
简要总结
Purpose of the trial is to study the efficacy of fractional laser in alleviating genitourinary symptoms in menopausal women.
Primary outcome of the study is the efficacy of the laser procedure, intended as the amelioration of the severity of most bothersome symptom (MBS).
Therefore we conducted a single center, double-blinded randomized placebo-controlled cross-over trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women with menopausal status (>1 year amenorrhea) AND with moderate to severe symptoms of VVA as measured by the MBS score ≥2.
排除标准
- •Acute or recurrent urogenital infections
- •Prolapse ≥ grade 3 according to the Pelvic Organ Prolapse Quantification System
- •Hormonal replacement therapy within the last 6 months before study entry
- •Use of local estrogens, moisturizers, lubricants or homeopathic preparations within the last 3 months
- •Pelvic floor physiotherapy for pelvic floor disorders within the last 3 months
- •Any condition that could interfere with study compliance
结局指标
主要结局
Primary outcome measure is the change in severity of most bothersome symptom (MBS)
时间窗: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
The MBS is derived from a selected list of symptoms (consisting of the four most common symptoms of vaginal dryness, vaginal itching/irritation, vaginal soreness and dyspareunia). At baseline, participants are instructed to rate each of these symptoms as not present, mild, moderate or severe and then are asked to select a single symptom among those classified as moderate or severe as the MBS. The MBS is then followed through to the end of treatment, and the change in its severity is used to evaluate symptomatic improvement.
次要结局
- Assessment of the degree of difficulty encountered by the physician in performing the treatment, by means of a 5-point Likert scale (1=very difficult, 2=difficult, 3=neutral, 4=easy, 5=very easy).(Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment)
- Assessment of the effect of treatment on the female urogenital health, by means of vaginal pH measurements.(Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment)
- Assessment of the long term satisfaction with, and the longevity of the effect of laser therapy, measured by the need for, and the timing for repeating the same, or initiating an alternative therapy.(Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment)
- Assessment of the effect of treatment on VVA symptoms (vaginal dryness, vaginal burning, vaginal itching, dyspareunia and dysuria) using the Visual Analog Scale (0-10cm, continuous scale).(Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment)
- Effect of treatment, in sexually active patients, on female sexual function, by means of the validated "Female Sexual Function Index" (FSFI) specific questionnaire(Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment)
- Assessment of the effect of treatment on the female urogenital health, by means of the globally validated "Vaginal Health Index Score" (VHIS).(Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment)
- Assessment of the rate of patient satisfaction by means of the Patient Global Impression of Improvement (PGI), using a 5-point Likert scale (1=much worse, 2=worse, 3=same, 4=better, 5=much better).(Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment)
- Assessment of the degree of discomfort of the treatment procedure by the patient, by mean of a VAS-score(0-10cm, continuous scale).(Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment)
- Assessment of the vaginal wall thickness using in vivo microscopy (vaginal focal depth measurement).(Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment)
研究者
prof. dr. Jan Deprest
Professor
Universitaire Ziekenhuizen KU Leuven
研究点 (2)
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