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Comparative study between CO2 laser and Fractional Radiofrequency in the treatment of Vaginal Atrophy

Not Applicable
Conditions
Atrophic Vaginitis
G08.686.157.500
Registration Number
RBR-2hgwvgy
Lead Sponsor
niversidade Brasil
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruitment completed
Sex
Female
Target Recruitment
Not specified
Inclusion Criteria

Physiologically postmenopausal women with amenorrhea longer than one year and plasma follicle-stimulating hormone dosage greater than 40 U/l and estradiol less than 25 pg/mL. Age between 50 and 70 years. Present clinical symptoms of the menopausal genitourinary syndrome. Current cervical cytological exam performed in the last six months negative for neoplasia

Exclusion Criteria

Women who have received any form of hormone replacement therapy in the past six months. Women who have used non-hormonal vaginal lubricants or moisturizers in the past month. Presence of active genital infections. Patients with a history of genital herpes who are unwilling to take oral Acyclovir prophylaxis. Women who have chronic inflammatory diseases that make the procedures unfeasible. Carriers of thrombophilia or regular users of anticoagulants or platelet antiaggregants. Patients that present vaginal prolapse of second or third degree according to the Pelvic Organ Prolapse Quantification System. Patients with a history of photosensitivity. Those who have had previous treatment with endovaginal CO2 laser or micro ablative Radiofrequency in any period

Study & Design

Study Type
Intervention
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Clinically and objectively assess urogenital health using the Vaginal Health Index (VHIS). The VHIS assesses the vaginal mucosa for its elasticity, pH, fluid volume, epithelial integrity, and mucosal lining. Each parameter is rated from 1 to 5, with a final score ranging from 5 to 25. If the total score is = 15, the vagina is considered atrophic.
Secondary Outcome Measures
NameTimeMethod
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