Lasers, Atrophy of Vagina, Atrophy Vulva
Conditions
Brief summary
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
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.
Interventions
PROCEDURELaser diiodo
3 laser diiodo procedures of 5-10 minutes at intervals of 4 weeks It is an outpatient procedure, not anesthesia required.
PROCEDURELaser Placebo
3 laser diiodo procedures of 5-10 minutes at intervals of 4 weeks. It is an outpatient procedure, not anesthesia required.
Sponsors
Hospital Italiano de Buenos Aires
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The patient and the outcomes assessor and principal investigator has not access to the randomization system
Intervention model description
Double blind, randomized, control clinical trial
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Female Sexual Function Index questionnaire | baseline, and week 4 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 | baseline, and week 4 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 | baseline, and week 4 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patient with Local Estrogen therapy requirement post intervention | baseline,and week 48 | Number of patients that Need estrogen replacement for atrophy vulvovaginal symptoms, despite the intervention.This will be evaluate with a Yes/No question. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participant with Adverse events reported in each visit | Baseline,and week 48 | It will be evaluate the number of patients that reported adverse events such as dyspareunia, irritation, edema, vaginal dryness, genital bleeding, vaginal discharge, pain, lesions |
Countries
Argentina
Outcome results
None listed