LASER and Radiofrequency and Genitourinary Syndrome of Menopause

NCT ID: NCT04045379

Last Updated: 2025-04-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-05
• Study Completion Date: 2025-08-31

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.

Conditions

Postmenopausal Atrophic Vaginitis; Postmenopausal Symptoms; Genitourinary Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

LASER

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

Group Type: ACTIVE_COMPARATOR

LASER

Intervention Type: 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.

Micro Ablative Radiofrequency

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

Group Type: ACTIVE_COMPARATOR

Microablative Radiofrequency

Intervention Type: 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.

Estriol

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.

Group Type: ACTIVE_COMPARATOR

Estriol

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Other Intervention Names

Fractional Co2 (carbon dioxide)Laser; MonaLisa Touch® treatment; SmartXide Touch V²LR® Deka; FRAAX; Linly™ Loktal Medical Electronics; Estriol 01mg/ml

Eligibility Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Ana Maria Homem de Mello Bianchi

Principal investigador

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zsuzsanna IK Jarmy - di Bella, PhD

Role: STUDY_CHAIR

Professor

Locations

Federal University of Sao Paulo - Unifesp

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 38085184 (View on PubMed)

Other Identifiers

CEP0431/2018 arm 1

Identifier Type: -

Identifier Source: org_study_id