NCT04045379

LASER and Radiofrequency and Genitourinary Syndrome of Menopause

LASER and Radiofrequency as Alternative Treatments for Genitourinary Syndrome of Menopause

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 195 (estimated)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2019-08-05
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2019-08-05
• Last updated: 2025-04-22

Locations

1 site across 1 country: Brazil