The Use of Laser in the Treatment of Atrophic Vulvovaginitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Use of Laser in the Treatment of Atrophic Vulvovaginitis and Its Consequent Improvement in Sexual Satisfaction

Conditions
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Lasers, Atrophy of Vagina, Atrophy Vulva

Intervention / Treatment
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* Procedure: Laser diiodo
* Procedure: Laser Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind, randomized, control clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 - Laser intervention<br>Laser diiodo treatment, 3 procedures of 5-10 minutes at intervals of 4 weeks | Procedure: Laser diiodo<br>* 3 laser diiodo procedures of 5-10 minutes at intervals of 4 weeks It is an outpatient procedure, not anesthesia required.<br>|
| Placebo Comparator: 2 - Laser placebo<br>Only the laser speculum is placed in the vagina but the laser is not activated. 3 procedures of 5-10 minutes at intervals of 4 weeks | Procedure: Laser Placebo<br>* 3 laser diiodo procedures of 5-10 minutes at intervals of 4 weeks. It is an outpatient procedure, not anesthesia required.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Female Sexual Function Index questionnaire | 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 | baseline, and week 4 after treatment | 
| Change from Baseline in Female Sexual Function Index questionnaire | 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 | baseline,and week 12 after treatment | 
| Change from Baseline in Female Sexual Function Index questionnaire | 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 | baseline, and week 36 after treatment | 
| Vaginal Cytology Improvement | 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 | baseline, and week 4 after treatment | 
| Vaginal Cytology Improvement | 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 | baseline, and week 12 after treatment | 
| Vaginal Cytology Improvement | 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 | baseline, and week 36 after treatment | 
| Change in vaginal acidity measure | 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) | baseline, and week 4 after treatment | 
| Change in vaginal acidity measure | 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) | baseline, and week 12 after treatment | 
| Change in vaginal pH measure | 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) | baseline,and week 36 after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient with Local Estrogen therapy requirement post intervention | Number of patients that Need estrogen replacement for atrophy vulvovaginal symptoms, despite the intervention.This will be evaluate with a Yes/No question. | baseline,and week 48 |