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Clinical trial

LASER and Radiofrequency as Alternative Treatments for Genitourinary Syndrome of Menopause

ID
Name
CEP0431/2018 arm 1
Description
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.
Trial arms
Trial start
2019-08-05
Estimated PCD
2024-08-01
Trial end
2025-08-01
Treatment
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.
Arms:
LASER
Other names:
Fractional Co2 (carbon dioxide)Laser, MonaLisa Touch® treatment, SmartXide Touch V²LR® Deka
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.
Arms:
Micro Ablative Radiofrequency
Other names:
FRAAX, Linly™ Loktal Medical Electronics
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.
Arms:
Estriol
Other names:
Estriol 01mg/ml
Size
195
Primary endpoint
Clinical Improvement of signs and symptoms postmenopausal genitourinary syndrome with intravaginal LASER, Microablative Radiofrequency, and topic estriol
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
The evaluation will be done 180 days after treatment
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. 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patient will be randomized in block to receive one of the three intravaginal therapies: LASER, Radiofrequency and topic estriol', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'the outcomes assessor will not know which therapy was used by the patient', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 195, 'type': 'ESTIMATED'}}
Updated at
2023-09-14

1 organization

1 product

3 indications

Organization
Federal University of São Paulo
Product
Estriol
Indication
Vaginal Atrophy
Indication
postmenopausal symptoms
Indication
Genitourinary Symptoms