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This protocol was cancelled due to the COVID pandemic restrictions in our country. It was imposible to complete the recruitment of patients to achive the study objectives.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 - Laser intervention | Experimental | Laser diiodo treatment, 3 procedures of 5-10 minutes at intervals of 4 weeks |
|
| 2 - Laser placebo | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser diiodo | Procedure | 3 laser diiodo procedures of 5-10 minutes at intervals of 4 weeks It is an outpatient procedure, not anesthesia required. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participant with Adverse events reported in each visit | 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 | Baseline,and week 48 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| claudia E Marchitelli, MD | Hospital Italiano de Buenos Aires, Argentina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Italiano de Buenos Aires | CABA | 1199 | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32010212 | Background | Knight C, Logan V, Fenlon D. A systematic review of laser therapy for vulvovaginal atrophy/genitourinary syndrome of menopause in breast cancer survivors. Ecancermedicalscience. 2019 Dec 12;13:988. doi: 10.3332/ecancer.2019.988. eCollection 2019. | |
| 32099629 | Result | Adabi K, Golshahi F, Niroomansh S, Razzaghi Z, Ghaemi M. Effect of the Fractional CO2 Laser on the Quality of Life, General Health, and Genitourinary Symptoms in Postmenopausal Women With Vaginal Atrophy: A Prospective Cohort. J Lasers Med Sci. 2020 Winter;11(1):65-69. doi: 10.15171/jlms.2020.11. Epub 2020 Jan 18. |
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Double blind, randomized, control clinical trial
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The patient and the outcomes assessor and principal investigator has not access to the randomization system
| Laser Placebo | Procedure | 3 laser diiodo procedures of 5-10 minutes at intervals of 4 weeks. It is an outpatient procedure, not anesthesia required. |
|
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 |