The Use of Laser in the Treatment of Atrophic Vulvovaginitis and Its Consequent Improvement in Sexual Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from Baseline in Female Sexual Function Index questionnaire
研究概览
简要总结
This study evaluates the efficacy and security of laser for atrophy treatment. Half of participants will receive the laser treatment and the other half placebo.
详细描述
Thermal laser treatments are proposed as the newest treatments for atrophy. Through the thermal effect it would stimulates de mucosa, enhances the collagen component and the vascularization. Collagen remodeling and new collagen synthesis has been suggested as a mechanism of laser induced skin resurfacing and remodeling of vaginal connective tissue.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The patient and the outcomes assessor and principal investigator has not access to the randomization system
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Menopause women with vulvovaginal symptoms of atrophy
- •No previous estrogen treatment for the last 30 days
- •Active sexual life (vaginal penetration)
- •Accept to participate
- •Pap atrophy or hypotrophy in the last year
排除标准
- •Vulvovaginal diseases
- •Abnormal uterine bleeding
- •Antidepressants drugs
- •Uncontrolled diabetes
- •Cervical intraepithelial lesions or cancer
- •Photosensitized or under treatment with photosensibilized drugs
- •Collagen diseases
- •Vulvovaginal infections in the last 15 days
- •Immunosuppressed patients or under immunosuppressed treatments
结局指标
主要结局
Change from Baseline in Female Sexual Function Index questionnaire
时间窗: baseline, and week 36 after treatment
Female Sexual Function Index is a self- administered questionnaire that evaluate 19 items about sexual life. Minimum score is 2, and the highest is 36. Higher score mean a better outcome
Vaginal Cytology Improvement
时间窗: baseline, and week 36 after treatment
Vagina cytology will be obtain to evaluate initial conditions of the vagina and modifications after treatment. Papanicolaou coloration and the count of superficial, intermediate, parabasal and basal cells will be applied to measure improvement of vaginal atrophy
Change in vaginal acidity measure
时间窗: baseline, and week 12 after treatment
the normal vaginal acidity is between 3,8 a 4,5. In postmenopausal women is higher. We are going to evaluate the improvement in vaginal acidity to normal values of premenopausal women. It will be evaluate with specific acidity measurement strips (this strips measures between 3.8 y 5.4)
Change in vaginal pH measure
时间窗: baseline,and week 36 after treatment
the normal vaginal ph is between 3,8 a 4,5. In postmenopausal women is higher. We are going to evaluate the improvement in vaginal acidity to normal values of premenopausal women. It will be evaluate with specific acidity measurement strips (this strips measures between 3.8 y 5.4)
次要结局
- Number of patient with Local Estrogen therapy requirement post intervention(baseline,and week 48)
研究者
CLAUDIA ESTER MARCHITELLI
Chief of the Gynecology department
Hospital Italiano de Buenos Aires