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Effect of Vaginal Laser in menopause: a comparative study on Genitourinary Symptoms

Genitourinary Syndrome of menopause in patients treated with Vaginal CO2 Laser: a randomized clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7bb6mhc
Enrollment
Unknown
Registered
2025-02-14
Start date
2018-10-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrophic vaginitis

Interventions

This is a controlled clinical study with two arms. Genitourinary Syndrome of Menopause (GSM) will be evaluated in postmenopausal women before and after vaginal laser treatment (one session every 30 da

Sponsors

Hospital de Clínicas de Porto Alegre
Lead Sponsor
Hospital de Clínicas de Porto Alegre
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Healthy postmenopausal women (at least 12 months since their last menstrual period, or with bilateral oophorectomy, or hysterectomized with follicle-stimulating hormone higher than 40 U/L; estradiol lower than 25 pg/mL); negative oncotic colpocytology within the last year; who agree to participate in the study and sign the informed consent form (ICF)

Exclusion criteria

Exclusion criteria: Active or recent (<15 days) vaginal lesions; use of hormone replacement therapy in the last 6 months; untreated genitourinary tract infections; abnormal uterine bleeding; history of photosensitivity disorder or use of photosensitizing drugs; grade II-III genital prolapse (according to the Pelvic Organ Prolapse Quantification system, POP-Q); bacterial or viral vaginal infection (HPV, Herpes); immunosuppression; chronic corticosteroid use; scleroderma; extensive prior radiotherapy; burns in the area; collagen disorders; pregnancy and breastfeeding; genital neoplasia; anticoagulant therapy; patients with sling/mesh; uncontrolled diabetes

Design outcomes

Primary

MeasureTime frame
An improvement in the symptoms of Genitourinary Syndrome of Menopause (GSM) is expected, assessed through standardized questionnaires on quality of life and intimate well-being, as well as morphometric analysis of the vaginal mucosa. Data will be collected before the start of treatment and three months after the intervention.

Countries

Brazil

Contacts

Public ContactEdison Capp

Hospital de Clínicas de Porto Alegre

edcapp@ufrgs.br+55 51 33598117

Outcome results

None listed

Source: REBEC (via WHO ICTRP)