LASER and Radiofrequency and Genitourinary Syndrome of Menopause

NCT04045379 | Active Not Recruiting

• 1 other identifier: CEP0431/2018 arm 1
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal Atrophic Vaginitis; Postmenopausal Symptoms; Genitourinary Symptoms

Keywords

postmenopause; atrophic vaginitis; vulvovaginal atrophy; treatment; LASER; Radiofrequency; estriol; strogen therapy

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (8)

• Evaluation of Microbiota before and after the use of intravaginal LASER, Micro Ablative radiofrequency or topic estriol.

  The evaluation will occur pre treatment 30, 90 , 180 and 360 days after treatment

• Evaluation of vaginal pH before and after the use of intravaginal LASER, Micro ablative radiofrequency or topic estriol.

  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.

  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 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 evaluation will occur pre treatment and 30 days after treatment

Study Arms (3)

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

Procedure: LASER

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

Procedure: Microablative Radiofrequency

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.

Drug: Estriol

Interventions

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.

Also known as: Fractional Co2 (carbon dioxide)Laser, MonaLisa Touch® treatment, SmartXide Touch V²LR® Deka

LASER

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.

Also known as: FRAAX, Linly™ Loktal Medical Electronics

Micro Ablative Radiofrequency

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.

Also known as: Estriol 01mg/ml

Estriol

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Active genital infection, active infection of HPV (human papillomavirus) or Herpes, users of medications with estrogenic effect (digoxin, tamoxifen and other chemicals)

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Federal University of Sao Paulo - Unifesp

São Paulo, São Paulo, 0-4023- 062, Brazil

Location

Related Publications (1)

• 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.

  PMID: 38085184 DERIVED

MeSH Terms

Conditions

Atrophic Vaginitis

Interventions

Lasers; Lasers, Gas; Estriol

Condition Hierarchy (Ancestors)

Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Zsuzsanna IK Jarmy - di Bella, PhD

  Professor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the outcomes assessor will not know which therapy was used by the patient
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigador

Model Details: The patient will be randomized in block to receive one of the three intravaginal therapies: LASER, Radiofrequency and topic estriol

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: August 5, 2019
• Study Start: August 5, 2019
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 22, 2025

Record last verified: 2025-04

Locations

BR (1)