LASER and Radiofrequency and Genitourinary Syndrome of Menopause

Postmenopausal Symptoms Clinical Trial

— EPMLARF-arm1  

Official title:

LASER and Radiofrequency as Alternative Treatments for Genitourinary Syndrome of Menopause

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04045379
• Other study ID #: CEP0431/2018 arm 1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 5, 2019
• Est. completion date: August 2025

Study information

• Verified date: September 2023
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 195
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophic Vaginitis
• Atrophy
• Genitourinary Symptoms
• Postmenopausal Atrophic Vaginitis
• Postmenopausal Symptoms
• Vaginitis

Intervention

Procedure:
• LASER
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.
• Microablative Radiofrequency
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.

Drug:
• Estriol
The patient will perform self application of this vaginal estriol daily for 2 weeks and after that the applications will occur twice a week.

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo - Unifesp	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.