NCT03956563Unknown不适用
Effect of Hybrid Laser 10600+1540 nm on Vaginal Atrophy-genitourinary Syndrome of the Menopause
Quanta System, S.p.A.2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年5月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Atrophic vaginal epithelium change
研究概览
简要总结
The primary objective of the study is to clinically confirm, by comparison with a control group, the performance of the 10600 +1540 nm laser in the improvement of atrophic vaginal epithelium at 3 months after the last laser treatment.
The secondary objectives are:
- Confirm the performance of 10600 +1540 nm laser in the improvement of atrophic vaginal epithelium at 9 months post-laser treatment, and compare it with the results at 3 months.
- Evaluate the improvement of the GSM urinary symptoms and urinary incontinence (UI) and their impact on the Quality of Life, at each timepoint after the first laser treatment.
- To assess the Patient's Global Impression of Improvement (PGI) with the laser treatment
- For the GSM symptoms
- For the urinary symptoms and UI
- To assess the patient's satisfaction with the laser treatment.
- For the GSM symptoms
- For the urinary symptoms and UI.
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)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Menopausal women (defined as ³1 year without menstruation until 65 years of age and no more than 10 years within the menopause) with at least 1 GSM symptom (vaginal dryness, burning, itching or dyspareunia ) Atrophic vaginal epithelium measured with the VMV values of 0-49%
- •To have any of the urinary symptoms: urgency, frequency, nocturia and urinary incontinence as symptoms of GSM
- •Women able to understand , accept and signed the Informed Consent.
- •Women with adequate physical and mental ability to understand and complete the questionnaires of quality of life and with cooperative attitude.
排除标准
- •VMV 50-64% (moderate) 65-100% (high estrogenic effect on the vaginal epithelium)
- •Impossibility of introducing the laser device
- •History or other energy-based vaginal therapy within 6 months prior to enrollment.
- •Being on hormone replacement therapy to relieve menopausal symptoms 3 months before the study.
- •Being on regular and effective topical estrogen therapy within the last 3 months.
- •Being on concomitant anticoagulants therapy .
- •Patients suffering of epileptic attacks and immunosuppressive diseases.
- •Daily and effective use of moisturizers, lubricants or probiotics.
- •Previous pelvic radiotherapy or brachytherapy
- •Gynecologic or rectal cancer less than 5 years ago
- •Breast cancer with antiestrogenic therapy
- •Bladder emptying dysfunction.
- •Women operated on UI.
- •Subjects undergoing conservative supervised treatment, such as pelvic floor rehabilitation exercises.
- •Genital prolapse grade III or higher, according to the simplified POPQ classification.
- •Being on effective pharmacological treatment for overactive bladder.
- •Taking diuretics.
- •Patients with neurological diseases (Multiple Sclerosis, spinal cord injury, stroke, Parkinson's)
- •Insulin-dependent diabetes mellitus (IDDM) or non-dependent insulin poorly controlled.
- •Body Mass Index (BMI) > 40 kg/m2
- •Active urinary tract infection
- •Women who present active or recurrent genital herpes.
- •Undiagnosed metrorrhagia
- •Abnormal last cervical cytology
- •Developmental disability, cognitive impairment and/or serious mental health illness.
- •Language barrier.
- •Women who refuse to participate in the study.
研究组 & 干预措施
Active treatment arm
Active Comparator
Youlaser MT: sequential 10600+1540 nm with vaginal (2 passes) and intritus (1 pass) treatment
干预措施: Youlaser MT Group 1 (Device)
Control arm
Sham Comparator
Youlaser MT: no laser emission with vaginal (2 passes) and intritus (1 pass) treatment
干预措施: Youlaser MT Group 2 (Device)
结局指标
主要结局
Atrophic vaginal epithelium change
时间窗: 3 months and 9 months post laser treatments
The primary efficacy outcome measure in this study is to obtain on the atrophic vaginal epithelium at 3 months after the last laser treatment, values going from absent/low estrogenization (0-49%) to moderate or high estrogenization (50-64%) measured with VMV. The results will be compared between the treatment and the control arm.
次要结局
- Treatment area success for GSM #1(3 months and 9 months post laser treatments)
- Treatment area success for GSM #2(3 months and 9 months post laser treatments)
- Treatment area success for Urinary incontinence #1(3 months and 9 months post laser treatments)
- Patient Global Impression(3 months and 9 months post laser treatments)
- Safety evaluation(61 days (at each treatment))
- Treatment area success for Urinary incontinence #2(3 months and 9 months post laser treatments)
- Treatment area success for Urinary incontinence #3(3 months and 9 months post laser treatments)
- Patient Satisfaction(3 months and 9 months post laser treatments)
研究者
研究点 (2)
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