Efficacy of Fractional CO2 Laser Treatment in Post-Menopausal Women With Vaginal Atrophy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The Vulvovaginal Symptoms Questionnaire (VVSQ)
研究概览
简要总结
Vaginal dryness, itching, burning, irritability, secretion, and various urinary problems are the symptoms of vulvovaginal atrophy. Therefore, more attention must be paid to relieve these symptoms in order to provide better sexual health for postmenopausal women. At present, an accumulating body of evidence suggests safety and efficacy of laser and energy-based devices for the treatment of women's genitourinary conditions. More clinical studies are needed to assess the safety profile and clinical outcomes of the lasers and energy-based devices to treat the symptoms associated with vulvovaginal atrophy (VVA)
详细描述
This is a prospective, investigational study that will be performed in private outpatient clinic on 30 participants.
All participants will be scheduled for four visits (V1, V2, V3, and V4) with a 4- week interval where they will receive the interventions in the first three visits (V1, V2, and V3), While in the last visit (V4), the study will assess the participants' satisfaction with the treatment and any adverse events they experienced during the study period.
Detailed medical history of all participants will be collected including age, age at menopause, parity, type of delivery, history of vaginal reconstructive surgery, history of hormonal treatment, and sexual activity status.
At each visit (V1, V2, V3, and V4), the participants will be interviewed to assess Vaginal Health Index using the VHI score and assess the changes in the Female Sexual Function Index FSFI.
Signs of vaginal atrophy will be evaluated during pelvic examination After pelvic examination and completion of the questionnaire, the interventions will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 whose ages ranged from 45 to 65 years.
- •Sexually active
- •Had symptoms of VVA (vaginal dryness, irritation, soreness, or dyspareunia)
排除标准
- •Any history of hormonal therapy within the past 6 months
- •Vaginal moisturizer or lubricant applications within the past 30 days
- •Acute/recurrent urinary tract infection
- •Active genital infection
- •Prolapse stage II or more based on examination
- •Psychiatric disorders
- •Undiagnosed vaginal bleeding
- •Any serious disease or chronic condition that could interfere with study compliance
研究组 & 干预措施
intervention by using the Fractional CO2 laser
. Using the following settings with the internal handpiece: square pattern with Deep Mode, fractional density of 5% and energy level of 50 mJ and fluence of 283 J/cm2. The handpiece will be inserted into the vagina (up to 10 cm) The handpiece will be positioned with contact to the vagina and will be rotated to apply 12 pulses at each 1-cm marking (application of laser energy at 3-10-cm depths) until the distal end of the vaginal probe reaches the introitus.
The laser application will be performed on an outpatient basis without local anesthesia in outpatient clinic.
干预措施: Fractional CO2 laser (Device)
结局指标
主要结局
The Vulvovaginal Symptoms Questionnaire (VVSQ)
时间窗: 4-6 months
The Vaginal Health Index VHI assessment.
时间窗: 4-6 months
次要结局
- Urogenital Distress Short Form (UDI-6(4-6 months)
- Incontinence Impact Questionnaire Short Form (IIQ-7)(4-6 months)
- Female Sexual Function Index (FSFI)(4-6 months)