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LASER and Radiofrequency and Genitourinary Syndrome of Menopause (EPMLARF-arm1)

Primary Purpose

Postmenopausal Atrophic Vaginitis, Postmenopausal Symptoms, Genitourinary Symptoms

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
LASER
Microablative Radiofrequency
Estriol
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Atrophic Vaginitis focused on measuring postmenopause, atrophic vaginitis, vulvovaginal atrophy, treatment, LASER, Radiofrequency, estriol, strogen therapy

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Women between 2 and 5 years after menopause, without hormone therapy for at least 2 years
  2. 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:

    • Burning
    • Discomfort
    • Dryness
    • Cracks
    • Pruritus
    • Lack of vaginal lubrication
    • Penetration dyspareunia that began at the menopausal or postmenopausal transition
    • Decreased vaginal epithelium turgor and trophism
    • Deletion of mucous and skin folds.

The Exclusion criteria will be:

  1. Active genital infection, active infection of HPV (human papillomavirus) or Herpes, users of medications with estrogenic effect (digoxin, tamoxifen and other chemicals)
  2. Postmenopausal genital bleeding, uncontrolled diabetes, use of multivitamins with zinc, use of copper or hormonal IUDs (intrauterine device) at the time of inclusion, presence of genitourinary or rectovaginal fistulas.

Sites / Locations

  • Federal University of Sao Paulo - Unifesp

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

LASER

Micro Ablative Radiofrequency

Estriol

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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
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
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
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
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
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
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

Full Information

First Posted
May 20, 2019
Last Updated
September 12, 2023
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04045379
Brief Title
LASER and Radiofrequency and Genitourinary Syndrome of Menopause
Acronym
EPMLARF-arm1
Official Title
LASER and Radiofrequency as Alternative Treatments for Genitourinary Syndrome of Menopause
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 5, 2019 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Atrophic Vaginitis, Postmenopausal Symptoms, Genitourinary Symptoms
Keywords
postmenopause, atrophic vaginitis, vulvovaginal atrophy, treatment, LASER, Radiofrequency, estriol, strogen therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patient will be randomized in block to receive one of the three intravaginal therapies: LASER, Radiofrequency and topic estriol
Masking
Outcomes Assessor
Masking Description
the outcomes assessor will not know which therapy was used by the patient
Allocation
Randomized
Enrollment
195 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LASER
Arm Type
Active Comparator
Arm Description
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
Arm Title
Micro Ablative Radiofrequency
Arm Type
Active Comparator
Arm Description
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
Arm Title
Estriol
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
LASER
Other Intervention Name(s)
Fractional Co2 (carbon dioxide)Laser, MonaLisa Touch® treatment, SmartXide Touch V²LR® Deka
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Microablative Radiofrequency
Other Intervention Name(s)
FRAAX, Linly™ Loktal Medical Electronics
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Estriol
Other Intervention Name(s)
Estriol 01mg/ml
Intervention Description
The patient will perform self application of this vaginal estriol daily for 2 weeks and after that the applications will occur twice a week.
Primary Outcome Measure Information:
Title
Clinical Improvement of signs and symptoms postmenopausal genitourinary syndrome with intravaginal LASER, Microablative Radiofrequency, and topic estriol
Description
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
Time Frame
The evaluation will be done 180 days after treatment
Title
Satisfaction of postmenopausal women with genitourinary syndrome with the treatment by intravaginal LASER, Micro ablative Radiofrequency, and topic estriol
Description
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
Time Frame
The evaluation will be done 180 days after treatment
Secondary Outcome Measure Information:
Title
Evaluation of Microbiota before and after the use of intravaginal LASER, Micro Ablative radiofrequency or topic estriol.
Description
The vaginal flora will be evaluated by vaginal smear. The results of the three groups will be compared
Time Frame
The evaluation will occur pre treatment 30, 90 , 180 and 360 days after treatment
Title
Evaluation of vaginal pH before and after the use of intravaginal LASER, Micro ablative radiofrequency or topic estriol.
Description
The vaginal pH will be verified by the use of pH tape's .The results of the three groups will be compared
Time Frame
The evaluation will occur pre treatment and 30, 90, 180 and 360 days after treatment
Title
Histologic evaluation of vagina and vulva before and after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol.
Description
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
Time Frame
The evaluation will occur pre treatment and 30 days after treatment
Title
Evaluation of impact in Quality of life after treatment with intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol.
Description
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
Time Frame
The evaluation will occur pre treatment and 30 days after treatment
Title
Evaluation of impact in Sexual function after treatment with intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol.
Description
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
Time Frame
The evaluation will occur pre treatment and 30 days after treatment
Title
Evaluation of extracellular matrix before and after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol.
Description
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
Time Frame
The evaluation will occur pre treatment and 30 days after treatment
Title
Evaluation of matrix metalloproteinases(MMP) in remodeling of vulvovaginal collagen induced by intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol.
Description
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
Time Frame
The evaluation will occur pre treatment and 30 days after treatment
Title
Evaluation of visual aspect of vulva after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic estriol.
Description
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
Time Frame
The pictures will be taken before and 30 days and 180 days after treatment.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Burning Discomfort Dryness Cracks Pruritus Lack of vaginal lubrication Penetration dyspareunia that began at the menopausal or postmenopausal transition Decreased vaginal epithelium turgor and trophism Deletion of mucous and skin folds. The Exclusion criteria will be: Active genital infection, active infection of HPV (human papillomavirus) or Herpes, users of medications with estrogenic effect (digoxin, tamoxifen and other chemicals) Postmenopausal genital bleeding, uncontrolled diabetes, use of multivitamins with zinc, use of copper or hormonal IUDs (intrauterine device) at the time of inclusion, presence of genitourinary or rectovaginal fistulas.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zsuzsanna IK Jarmy - di Bella, PhD
Organizational Affiliation
Professor
Official's Role
Study Chair
Facility Information:
Facility Name
Federal University of Sao Paulo - Unifesp
City
São Paulo
State/Province
SP
ZIP/Postal Code
0-4023- 062
Country
Brazil

12. IPD Sharing Statement

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LASER and Radiofrequency and Genitourinary Syndrome of Menopause

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