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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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This is a randomized controlled trial to evaluate the use of LASER, Micro Ablative radiofrequency and topic strogen to treat symptoms of vulvovaginal atrophy of post menopause.
Post menopause women with moderate or severe signs or symptoms of vulvovaginal atrophy will be eligible for the study.
The patients will be randomized to receive one of the three intravaginal therapies: LASER, Micro Ablative radiofrequency or Estriol. The applications will occur in the interval of 30 days for 3 times, for LASER and Radiofrequency groups. For the estriol group, the application will be done by the patient, daily for 2 weeks and them twice a week for 3 months, and each 30 days, the patients will have an appointment when will be checked the weight of the estriol tube, to verify the correct use.
The follow-up visits will occur 30, 90, 180 and 360 days after the conclusion of the third month of treatment.
Will be evaluated: vulvar and vaginal histology before and after the use of LASER, radiofrequency or estriol; microbiota and vaginal pH before and after the use of LASER, radiofrequency or estriol; extracellular matrix and metalloproteinases in the remodeling of vulvovaginal collagen induced by estrogen, LASER and radiofrequency; quality of life, sexual dysfunctions and complaints before and after the use of LASER, radiofrequency or hormones; metabolomics and vaginal microbiome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LASER | Active Comparator | The patients will receive 3 consecutive applications of intravaginal and vulvar CO2 (carbon dioxide)LASER, according to the manufacturer protocol for vaginal atrophy. The applications will be separated by the interval of 30 days |
|
| Micro Ablative Radiofrequency | Active Comparator | The patients will receive 3 consecutive applications of intravaginal and vulvar MIcro ablative radiofrequency, according to the manufacturer protocol for vaginal atrophy. The applications will be separated by the interval of 30 days |
|
| Estriol | Active Comparator | The patient will use intravaginal estriol, daily for 2 weeks and them twice a week for 3 months . Each 30 days, the patients will have an appointment when will be checked the weight of the estriol tube to verify the correct use. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LASER | Procedure | Use of the SmartXide Touch V²LR, Co2 Laser System to perform ambulatory intravaginal and vulvar application of LASER, to postmenopausal genitourinary syndrome. The patient will be in gynecological position, after remove of vaginal secretion, with gauze and under topic anesthesia, the LASER will be applied, according to the protocol of the manufactured. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Improvement of signs and symptoms postmenopausal genitourinary syndrome with intravaginal LASER, Microablative Radiofrequency, and topic estriol | Will be applied a Visual Analogic Scale (0-10) to access the improvement of genitourinary signs and symptoms, the results of the three groups will be compared | The evaluation will be done 180 days after treatment |
| Satisfaction of postmenopausal women with genitourinary syndrome with the treatment by intravaginal LASER, Micro ablative Radiofrequency, and topic estriol | Will be applied a LIKERT Satisfaction Scale (1-5) to access the satisfaction with the treatment, the results of the three groups will be compared | The evaluation will be done 180 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Microbiota before and after the use of intravaginal LASER, Micro Ablative radiofrequency or topic estriol. | The vaginal flora will be evaluated by vaginal smear. The results of the three groups will be compared | The evaluation will occur pre treatment 30, 90 , 180 and 360 days after treatment |
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Inclusion Criteria:
Women between 2 and 5 years after menopause, without hormone therapy for at least 2 years
To present, at least moderate, or severe intensity (score 4 or more of visual analog scale ( 0-10)) of one of the signs or symptoms of of vulvovaginal atrophy:
The Exclusion criteria will be:
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| Name | Affiliation | Role |
|---|---|---|
| Zsuzsanna IK Jarmy - di Bella, PhD | Professor | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Sao Paulo - Unifesp | São Paulo | São Paulo | 0-4023- 062 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38085184 | Derived | de Oliveira CD, de Mello Bianchi AMH, Campos MLP, Nogueira MCC, Sartori MGF, de Gois Speck NM. Women with Genitourinary Syndrome of Menopause Treated with Vaginal Estriol, Microablative Fractional CO2 Laser and Microablative Fractional Radiofrequency: A Randomized Pilot Study. Photobiomodul Photomed Laser Surg. 2023 Dec;41(12):718-724. doi: 10.1089/photob.2023.0113. |
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| ID | Term |
|---|---|
| D059268 | Atrophic Vaginitis |
| ID | Term |
|---|---|
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D007834 | Lasers |
| D054020 | Lasers, Gas |
| D004964 | Estriol |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
| D004963 | Estrenes |
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The patient will be randomized in block to receive one of the three intravaginal therapies: LASER, Radiofrequency and topic estriol
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the outcomes assessor will not know which therapy was used by the patient
|
|
| Microablative Radiofrequency | Procedure | Use of Linly™ equipment to perform ambulatory intravaginal and vulvar application of fractionated microablative radiofrequency, to postmenopausal genitourinary syndrome. The patient will be in gynecological position, after remove of vaginal secretion, with gauze and under topic anesthesia, the radiofrequency will be applied, according to the protocol of the manufactured. |
|
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| Estriol | Drug | The patient will perform self application of this vaginal estriol daily for 2 weeks and after that the applications will occur twice a week. |
|
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| Evaluation of vaginal pH before and after the use of intravaginal LASER, Micro ablative radiofrequency or topic estriol. |
The vaginal pH will be verified by the use of pH tape's .The results of the three groups will be compared |
| The evaluation will occur pre treatment and 30, 90, 180 and 360 days after treatment |
| Histologic evaluation of vagina and vulva before and after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol. | Thickness of epithelium (mm and number of layers), and evaluation of expression of Ki-67 and VEGF (vascular endothelial growth factor) will be done on vaginal and vulvar biopsies.The results of the three groups will be compared | The evaluation will occur pre treatment and 30 days after treatment |
| Evaluation of impact in Quality of life after treatment with intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol. | The IQol (incontinence quality of life questionnaire, validated to portuguese language - score 0-100) will be used to evaluate quality of life .The results of the three groups will be compared | The evaluation will occur pre treatment and 30 days after treatment |
| Evaluation of impact in Sexual function after treatment with intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol. | The FSF-I(Female Sexual Function Index , validated to portuguese language- score range from 2 - 36) will be used to evaluate sexual function . The results of the three groups will be compared | The evaluation will occur pre treatment and 30 days after treatment |
| Evaluation of extracellular matrix before and after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol. | Evaluation of the composition and concentration of the glycosaminoglycans of extracellular matrix in the vaginal and vulvar biopsies by specific markers. The results of the three groups will be compared | The evaluation will occur pre treatment and 30 days after treatment |
| Evaluation of matrix metalloproteinases(MMP) in remodeling of vulvovaginal collagen induced by intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol. | Evaluation of the tissue distribution of the MMP-1, MMP-2, MMP-3, MMP-7, MMP-9 metalloproteinases of collagen I, II, IV and elastin proteins by specific markers on vaginal and vulvar biopsies. The results of the three groups will be compared | The evaluation will occur pre treatment and 30 days after treatment |
| Evaluation of visual aspect of vulva after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol. | Pictures of vulva will be taken before and after treatment. The images will be evaluated by a blind gynecologist and dermatologist regarding the type of treatment and the chronological order of the photos, which will classify the images as: better; equal or worse, in relation to tropism and number of vulvar skin grooves, The results of the three groups will be compared | The pictures will be taken before and 30 days and 180 days after treatment. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004962 |
| Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |